Trial Outcomes & Findings for A Study to Assess Wound Healing Efficacies of Different Adhesive Bandages (NCT NCT04040933)
NCT ID: NCT04040933
Last Updated: 2023-07-03
Results Overview
Time to complete wound healing: time(in days) elapsed from time of wound creation to 12 PM of day (up to Day 16) on which composite healing score(CHS) first meets complete healing criterion of being at least a score of 8 (threshold for complete healing). CHS was calculated from clinical grading of wound healing parameters as general wound appearance (0 \[Poor-New or fresh wound with epithelium layer missing, wound bed appears raw and possibly oozing\] to 4 \[Excellent-Fully healed, skin flush against surrounding skin, slight color mismatch may be present\])+smoothness (0 \[Rough, uneven wound\]- 4 \[complete smoothness, even wound\])+epithelial confluence (0 \[None\]- 4 \[91-100%full epithelial growth\]) - erythema (0 \[None\]- 4 \[Severe\]) - edema (0 \[None\]- 4 \[Severe\]) - crusting/scabbing (0 \[None\]- 4 \[90-100% crusting/scabbing\]). CHS on 25-point scale (-12 \[no healing\] to +12 \[towards healing\]) is indicative of extent of wound healing and was calculated for each wound site at each evaluation day.
COMPLETED
NA
36 participants
Up to Day 16
2023-07-03
Participant Flow
All participants received all eight intervention at the same time on their forearms. At Screening (Visit 1; 3 to 7 days prior to Baseline), participants were provided with an auxiliary cleanser to use on their forearms and for all body cleansing in place of their regular body cleanser for the duration of the study. As planned, for all outcome measures, the results are reported for each bandage separately.
Participant milestones
| Measure |
All Randomized Participants
All Participants with Fitzpatrick skin types II (burns easily; tans minimum)-III (burns moderately; tans gradually) with uniform skin color on forearms, minor wounds were created on forearms (four per arm) by a certified laser specialist received all eight intervention at the same time on the wounds created on forearms. Each wound site was subjected to one of eight randomly-assigned treatments included in an adhesive bandage that were: 1) a marketed adhesive bandage, 2) a marketed adhesive bandage (IP-benchmark control 1), 3) a non-marketed adhesive bandage (IP-benchmark control 2), 4-7) four non-marketed adhesive bandages (IP#1, IP#2, IP#3, IP#4), and 8) no treatment (uncovered, negative control). Bandages were changed daily/every other day until the wound reached a composite healing score of 8. The bandages were not left on after a composite healing score of 8 was achieved.
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|---|---|
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Overall Study
STARTED
|
36
|
|
Overall Study
Treated
|
36
|
|
Overall Study
COMPLETED
|
33
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
All Randomized Participants
All Participants with Fitzpatrick skin types II (burns easily; tans minimum)-III (burns moderately; tans gradually) with uniform skin color on forearms, minor wounds were created on forearms (four per arm) by a certified laser specialist received all eight intervention at the same time on the wounds created on forearms. Each wound site was subjected to one of eight randomly-assigned treatments included in an adhesive bandage that were: 1) a marketed adhesive bandage, 2) a marketed adhesive bandage (IP-benchmark control 1), 3) a non-marketed adhesive bandage (IP-benchmark control 2), 4-7) four non-marketed adhesive bandages (IP#1, IP#2, IP#3, IP#4), and 8) no treatment (uncovered, negative control). Bandages were changed daily/every other day until the wound reached a composite healing score of 8. The bandages were not left on after a composite healing score of 8 was achieved.
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|---|---|
|
Overall Study
Protocol Violation
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1
|
|
Overall Study
Withdrawal by Subject
|
2
|
Baseline Characteristics
A Study to Assess Wound Healing Efficacies of Different Adhesive Bandages
Baseline characteristics by cohort
| Measure |
All Randomized Participants
n=36 Participants
All Participants with Fitzpatrick skin types II (burns easily; tans minimum)-III (burns moderately; tans gradually) with uniform skin color on forearms, minor wounds were created on forearms (four per arm) by a certified laser specialist received all eight intervention at the same time on the wounds created on forearms. Each wound site was subjected to one of eight randomly-assigned treatments included in an adhesive bandage that were: 1) a marketed adhesive bandage, 2) a marketed adhesive bandage (IP-benchmark control 1), 3) a non-marketed adhesive bandage (IP-benchmark control 2), 4-7) four non-marketed adhesive bandages (IP#1, IP#2, IP#3, IP#4), and 8) no treatment (uncovered, negative control). Bandages were changed daily/every other day until the wound reached a composite healing score of 8. The bandages were not left on after a composite healing score of 8 was achieved.
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|---|---|
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Age, Continuous
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43.0 Years
STANDARD_DEVIATION 8.01 • n=99 Participants
|
|
Sex: Female, Male
Female
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30 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
28 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
33 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Fitzpatrick Skin Classification
Fitzpatrick Skin Classification - II
|
24 Participants
n=99 Participants
|
|
Fitzpatrick Skin Classification
Fitzpatrick Skin Classification - III
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12 Participants
n=99 Participants
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PRIMARY outcome
Timeframe: Up to Day 16Population: The Intent-to-Treat (ITT) set include all participants who received laser-induced wounds and started the study treatments. As planned, for this outcome measure, the data was reported for each bandage separately.
Time to complete wound healing: time(in days) elapsed from time of wound creation to 12 PM of day (up to Day 16) on which composite healing score(CHS) first meets complete healing criterion of being at least a score of 8 (threshold for complete healing). CHS was calculated from clinical grading of wound healing parameters as general wound appearance (0 \[Poor-New or fresh wound with epithelium layer missing, wound bed appears raw and possibly oozing\] to 4 \[Excellent-Fully healed, skin flush against surrounding skin, slight color mismatch may be present\])+smoothness (0 \[Rough, uneven wound\]- 4 \[complete smoothness, even wound\])+epithelial confluence (0 \[None\]- 4 \[91-100%full epithelial growth\]) - erythema (0 \[None\]- 4 \[Severe\]) - edema (0 \[None\]- 4 \[Severe\]) - crusting/scabbing (0 \[None\]- 4 \[90-100% crusting/scabbing\]). CHS on 25-point scale (-12 \[no healing\] to +12 \[towards healing\]) is indicative of extent of wound healing and was calculated for each wound site at each evaluation day.
Outcome measures
| Measure |
Negative Control
n=36 Participants
Minor wounds were created on participant's forearms (four per arm) by a certified laser specialist. On the randomized wound site, no treatment was applied as the wound remained uncovered as negative control.
|
Marketed Adhesive Bandage
n=36 Participants
Minor wounds were created on participant's forearms (four per arm) by a certified laser specialist. On the randomized wound site, marketed adhesive bandage was applied. Bandages were changed daily/every other day until the wound reached a composite healing score of 8. The bandage was not left on after a composite healing score of 8 was achieved.
|
Marketed Adhesive Bandage IP-1 Benchmark Control 1
n=36 Participants
Minor wounds were created on participant's forearms (four per arm) by a certified laser specialist. On the randomized wound site, benchmark control 1 bandage was applied. Bandages were changed daily/every other day until the wound reached a composite healing score of 8. The bandage was not left on after a composite healing score of 8 was achieved.
|
Non-marketed Adhesive Bandage IP-Benchmark Control 2
n=36 Participants
Minor wounds were created on participant's forearms (four per arm) by a certified laser specialist. On the randomized wound site, benchmark control 2 bandage was applied. Bandages were changed daily/every other day until the wound reached a composite healing score of 8. The bandage was not left on after a composite healing score of 8 was achieved.
|
Non-marketed Adhesive Bandage IP #1
n=36 Participants
Minor wounds were created on participant's forearms (four per arm) by a certified laser specialist. On the randomized wound site, non-marketed IP#1 bandage was applied. Bandages were changed daily/every other day until the wound reached a composite healing score of 8. The bandage was not left on after a composite healing score of 8 was achieved.
|
Non-marketed Adhesive Bandage IP #2
n=36 Participants
Minor wounds were created on participant's forearms (four per arm) by a certified laser specialist. On the randomized wound site, non-marketed IP#2 bandage was applied. Bandages were changed daily/every other day until the wound reached a composite healing score of 8. The bandage was not left on after a composite healing score of 8 was achieved.
|
Non-marketed Adhesive Bandage IP #3
n=36 Participants
Minor wounds were created on participant's forearms (four per arm) by a certified laser specialist. On the randomized wound site, non-marketed IP#3 bandage was applied. Bandages were changed daily/every other day until the wound reached a composite healing score of 8. The bandage was not left on after a composite healing score of 8 was achieved.
|
Non-marketed Adhesive Bandage IP #4
n=36 Participants
Minor wounds were created on participant's forearms (four per arm) by a certified laser specialist. On the randomized wound site, non-marketed IP#4 bandage was applied. Bandages were changed daily/every other day until the wound reached a composite healing score of 8. The bandage was not left on after a composite healing score of 8 was achieved.
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|---|---|---|---|---|---|---|---|---|
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Time to Complete Wound Healing
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11.8 Days
Interval 1.0 to 16.0
|
11.9 Days
Interval 1.0 to 16.0
|
6.9 Days
Interval 1.0 to 16.0
|
10.9 Days
Interval 1.0 to 16.0
|
5.1 Days
Interval 1.0 to 16.0
|
12.9 Days
Interval 1.0 to 16.0
|
12 Days
Interval 1.0 to 16.0
|
15.9 Days
Interval 1.0 to 16.0
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SECONDARY outcome
Timeframe: Day 0 (immediate after wound creation), Day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14Population: The Intent-to-Treat (ITT) set include all participants who received laser-induced wounds and started the study treatments. Here 'n' (number analyzed) included all evaluable participants analyzed at specified timepoints. As planned, for this outcome measure, the data was reported for each bandage separately.
Change from Baseline in TEWL was reported. TEWL is the passive transfer of water through stratum corneum and was measured for each wound site using Tewameter TM330T. TEWL is a non-invasive method to measure the integrity of stratum corneum barrier function. Tewameter probe measures the density gradient of the water evaporation from the skin indirectly by two pairs of sensors (temperature and relative humidity) inside a hollow cylinder. The probe was held in place on the skin for one measurement, for 40 sec, to ensure that a stable value has been established. The values of the last 10 sec are averaged as the actual measurement values. An increase in TEWL values shows damage to the skin barrier function.
Outcome measures
| Measure |
Negative Control
n=36 Participants
Minor wounds were created on participant's forearms (four per arm) by a certified laser specialist. On the randomized wound site, no treatment was applied as the wound remained uncovered as negative control.
|
Marketed Adhesive Bandage
n=36 Participants
Minor wounds were created on participant's forearms (four per arm) by a certified laser specialist. On the randomized wound site, marketed adhesive bandage was applied. Bandages were changed daily/every other day until the wound reached a composite healing score of 8. The bandage was not left on after a composite healing score of 8 was achieved.
|
Marketed Adhesive Bandage IP-1 Benchmark Control 1
n=36 Participants
Minor wounds were created on participant's forearms (four per arm) by a certified laser specialist. On the randomized wound site, benchmark control 1 bandage was applied. Bandages were changed daily/every other day until the wound reached a composite healing score of 8. The bandage was not left on after a composite healing score of 8 was achieved.
|
Non-marketed Adhesive Bandage IP-Benchmark Control 2
n=36 Participants
Minor wounds were created on participant's forearms (four per arm) by a certified laser specialist. On the randomized wound site, benchmark control 2 bandage was applied. Bandages were changed daily/every other day until the wound reached a composite healing score of 8. The bandage was not left on after a composite healing score of 8 was achieved.
|
Non-marketed Adhesive Bandage IP #1
n=36 Participants
Minor wounds were created on participant's forearms (four per arm) by a certified laser specialist. On the randomized wound site, non-marketed IP#1 bandage was applied. Bandages were changed daily/every other day until the wound reached a composite healing score of 8. The bandage was not left on after a composite healing score of 8 was achieved.
|
Non-marketed Adhesive Bandage IP #2
n=36 Participants
Minor wounds were created on participant's forearms (four per arm) by a certified laser specialist. On the randomized wound site, non-marketed IP#2 bandage was applied. Bandages were changed daily/every other day until the wound reached a composite healing score of 8. The bandage was not left on after a composite healing score of 8 was achieved.
|
Non-marketed Adhesive Bandage IP #3
n=36 Participants
Minor wounds were created on participant's forearms (four per arm) by a certified laser specialist. On the randomized wound site, non-marketed IP#3 bandage was applied. Bandages were changed daily/every other day until the wound reached a composite healing score of 8. The bandage was not left on after a composite healing score of 8 was achieved.
|
Non-marketed Adhesive Bandage IP #4
n=36 Participants
Minor wounds were created on participant's forearms (four per arm) by a certified laser specialist. On the randomized wound site, non-marketed IP#4 bandage was applied. Bandages were changed daily/every other day until the wound reached a composite healing score of 8. The bandage was not left on after a composite healing score of 8 was achieved.
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|---|---|---|---|---|---|---|---|---|
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Change From Baseline in Trans-Epidermal Water Loss (TEWL) Measurements
Day 0
|
39.27 gram (g)/meter(m)^2/hour (g/m^2/hr)
Standard Deviation 8.240
|
37.99 gram (g)/meter(m)^2/hour (g/m^2/hr)
Standard Deviation 10.050
|
—
|
39.57 gram (g)/meter(m)^2/hour (g/m^2/hr)
Standard Deviation 8.796
|
40.71 gram (g)/meter(m)^2/hour (g/m^2/hr)
Standard Deviation 9.284
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39.06 gram (g)/meter(m)^2/hour (g/m^2/hr)
Standard Deviation 11.257
|
36.47 gram (g)/meter(m)^2/hour (g/m^2/hr)
Standard Deviation 8.789
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38.74 gram (g)/meter(m)^2/hour (g/m^2/hr)
Standard Deviation 7.455
|
|
Change From Baseline in Trans-Epidermal Water Loss (TEWL) Measurements
Day 2
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25.31 gram (g)/meter(m)^2/hour (g/m^2/hr)
Standard Deviation 12.042
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16.74 gram (g)/meter(m)^2/hour (g/m^2/hr)
Standard Deviation 11.902
|
—
|
14.08 gram (g)/meter(m)^2/hour (g/m^2/hr)
Standard Deviation 14.260
|
7.47 gram (g)/meter(m)^2/hour (g/m^2/hr)
Standard Deviation 6.792
|
11.68 gram (g)/meter(m)^2/hour (g/m^2/hr)
Standard Deviation 7.032
|
9.59 gram (g)/meter(m)^2/hour (g/m^2/hr)
Standard Deviation 6.051
|
19.55 gram (g)/meter(m)^2/hour (g/m^2/hr)
Standard Deviation 11.594
|
|
Change From Baseline in Trans-Epidermal Water Loss (TEWL) Measurements
Day 3
|
12.80 gram (g)/meter(m)^2/hour (g/m^2/hr)
Standard Deviation 13.071
|
7.24 gram (g)/meter(m)^2/hour (g/m^2/hr)
Standard Deviation 9.361
|
2.33 gram (g)/meter(m)^2/hour (g/m^2/hr)
Standard Deviation 7.219
|
5.67 gram (g)/meter(m)^2/hour (g/m^2/hr)
Standard Deviation 11.081
|
4.60 gram (g)/meter(m)^2/hour (g/m^2/hr)
Standard Deviation 7.837
|
7.01 gram (g)/meter(m)^2/hour (g/m^2/hr)
Standard Deviation 5.896
|
5.37 gram (g)/meter(m)^2/hour (g/m^2/hr)
Standard Deviation 7.189
|
7.05 gram (g)/meter(m)^2/hour (g/m^2/hr)
Standard Deviation 8.513
|
|
Change From Baseline in Trans-Epidermal Water Loss (TEWL) Measurements
Day 1
|
39.70 gram (g)/meter(m)^2/hour (g/m^2/hr)
Standard Deviation 9.681
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37.86 gram (g)/meter(m)^2/hour (g/m^2/hr)
Standard Deviation 11.667
|
—
|
36.30 gram (g)/meter(m)^2/hour (g/m^2/hr)
Standard Deviation 10.345
|
31.48 gram (g)/meter(m)^2/hour (g/m^2/hr)
Standard Deviation 11.157
|
34.96 gram (g)/meter(m)^2/hour (g/m^2/hr)
Standard Deviation 10.541
|
30.48 gram (g)/meter(m)^2/hour (g/m^2/hr)
Standard Deviation 8.864
|
40.14 gram (g)/meter(m)^2/hour (g/m^2/hr)
Standard Deviation 13.278
|
|
Change From Baseline in Trans-Epidermal Water Loss (TEWL) Measurements
Day 4
|
5.81 gram (g)/meter(m)^2/hour (g/m^2/hr)
Standard Deviation 10.096
|
2.65 gram (g)/meter(m)^2/hour (g/m^2/hr)
Standard Deviation 7.517
|
—
|
1.14 gram (g)/meter(m)^2/hour (g/m^2/hr)
Standard Deviation 9.210
|
5.09 gram (g)/meter(m)^2/hour (g/m^2/hr)
Standard Deviation 7.174
|
5.55 gram (g)/meter(m)^2/hour (g/m^2/hr)
Standard Deviation 11.303
|
3.71 gram (g)/meter(m)^2/hour (g/m^2/hr)
Standard Deviation 6.299
|
1.37 gram (g)/meter(m)^2/hour (g/m^2/hr)
Standard Deviation 7.505
|
|
Change From Baseline in Trans-Epidermal Water Loss (TEWL) Measurements
Day 5
|
1.62 gram (g)/meter(m)^2/hour (g/m^2/hr)
Standard Deviation 7.636
|
-0.21 gram (g)/meter(m)^2/hour (g/m^2/hr)
Standard Deviation 6.273
|
-0.64 gram (g)/meter(m)^2/hour (g/m^2/hr)
Standard Deviation 6.867
|
-1.47 gram (g)/meter(m)^2/hour (g/m^2/hr)
Standard Deviation 5.626
|
7.33 gram (g)/meter(m)^2/hour (g/m^2/hr)
Standard Deviation 8.932
|
4.56 gram (g)/meter(m)^2/hour (g/m^2/hr)
Standard Deviation 5.270
|
1.88 gram (g)/meter(m)^2/hour (g/m^2/hr)
Standard Deviation 5.856
|
-2.42 gram (g)/meter(m)^2/hour (g/m^2/hr)
Standard Deviation 4.974
|
|
Change From Baseline in Trans-Epidermal Water Loss (TEWL) Measurements
Day 6
|
5.40 gram (g)/meter(m)^2/hour (g/m^2/hr)
Standard Deviation 7.519
|
3.02 gram (g)/meter(m)^2/hour (g/m^2/hr)
Standard Deviation 7.410
|
—
|
3.73 gram (g)/meter(m)^2/hour (g/m^2/hr)
Standard Deviation 7.495
|
9.36 gram (g)/meter(m)^2/hour (g/m^2/hr)
Standard Deviation 7.163
|
6.56 gram (g)/meter(m)^2/hour (g/m^2/hr)
Standard Deviation 5.736
|
6.35 gram (g)/meter(m)^2/hour (g/m^2/hr)
Standard Deviation 5.221
|
1.04 gram (g)/meter(m)^2/hour (g/m^2/hr)
Standard Deviation 6.633
|
|
Change From Baseline in Trans-Epidermal Water Loss (TEWL) Measurements
Day 7
|
1.89 gram (g)/meter(m)^2/hour (g/m^2/hr)
Standard Deviation 7.505
|
0.42 gram (g)/meter(m)^2/hour (g/m^2/hr)
Standard Deviation 6.266
|
4.33 gram (g)/meter(m)^2/hour (g/m^2/hr)
Standard Deviation 6.751
|
2.95 gram (g)/meter(m)^2/hour (g/m^2/hr)
Standard Deviation 14.523
|
9.45 gram (g)/meter(m)^2/hour (g/m^2/hr)
Standard Deviation 8.722
|
4.70 gram (g)/meter(m)^2/hour (g/m^2/hr)
Standard Deviation 5.079
|
3.51 gram (g)/meter(m)^2/hour (g/m^2/hr)
Standard Deviation 7.782
|
-0.78 gram (g)/meter(m)^2/hour (g/m^2/hr)
Standard Deviation 6.177
|
|
Change From Baseline in Trans-Epidermal Water Loss (TEWL) Measurements
Day 8
|
2.29 gram (g)/meter(m)^2/hour (g/m^2/hr)
Standard Deviation 6.629
|
2.22 gram (g)/meter(m)^2/hour (g/m^2/hr)
Standard Deviation 8.670
|
—
|
2.66 gram (g)/meter(m)^2/hour (g/m^2/hr)
Standard Deviation 7.315
|
9.24 gram (g)/meter(m)^2/hour (g/m^2/hr)
Standard Deviation 8.642
|
5.81 gram (g)/meter(m)^2/hour (g/m^2/hr)
Standard Deviation 5.742
|
5.16 gram (g)/meter(m)^2/hour (g/m^2/hr)
Standard Deviation 6.224
|
1.61 gram (g)/meter(m)^2/hour (g/m^2/hr)
Standard Deviation 8.170
|
|
Change From Baseline in Trans-Epidermal Water Loss (TEWL) Measurements
Day 9
|
2.67 gram (g)/meter(m)^2/hour (g/m^2/hr)
Standard Deviation 8.623
|
3.60 gram (g)/meter(m)^2/hour (g/m^2/hr)
Standard Deviation 6.604
|
7.75 gram (g)/meter(m)^2/hour (g/m^2/hr)
Standard Deviation 7.210
|
3.15 gram (g)/meter(m)^2/hour (g/m^2/hr)
Standard Deviation 9.808
|
7.44 gram (g)/meter(m)^2/hour (g/m^2/hr)
Standard Deviation 6.151
|
6.50 gram (g)/meter(m)^2/hour (g/m^2/hr)
Standard Deviation 5.898
|
4.49 gram (g)/meter(m)^2/hour (g/m^2/hr)
Standard Deviation 6.350
|
1.60 gram (g)/meter(m)^2/hour (g/m^2/hr)
Standard Deviation 7.721
|
|
Change From Baseline in Trans-Epidermal Water Loss (TEWL) Measurements
Day 10
|
0.61 gram (g)/meter(m)^2/hour (g/m^2/hr)
Standard Deviation 6.125
|
1.84 gram (g)/meter(m)^2/hour (g/m^2/hr)
Standard Deviation 7.714
|
—
|
0.81 gram (g)/meter(m)^2/hour (g/m^2/hr)
Standard Deviation 6.908
|
5.50 gram (g)/meter(m)^2/hour (g/m^2/hr)
Standard Deviation 6.187
|
3.79 gram (g)/meter(m)^2/hour (g/m^2/hr)
Standard Deviation 5.137
|
3.78 gram (g)/meter(m)^2/hour (g/m^2/hr)
Standard Deviation 6.538
|
-0.48 gram (g)/meter(m)^2/hour (g/m^2/hr)
Standard Deviation 6.885
|
|
Change From Baseline in Trans-Epidermal Water Loss (TEWL) Measurements
Day 11
|
1.30 gram (g)/meter(m)^2/hour (g/m^2/hr)
Standard Deviation 5.810
|
2.76 gram (g)/meter(m)^2/hour (g/m^2/hr)
Standard Deviation 7.082
|
4.20 gram (g)/meter(m)^2/hour (g/m^2/hr)
Standard Deviation 7.264
|
1.78 gram (g)/meter(m)^2/hour (g/m^2/hr)
Standard Deviation 7.190
|
5.60 gram (g)/meter(m)^2/hour (g/m^2/hr)
Standard Deviation 7.211
|
5.11 gram (g)/meter(m)^2/hour (g/m^2/hr)
Standard Deviation 4.491
|
6.89 gram (g)/meter(m)^2/hour (g/m^2/hr)
Standard Deviation 8.666
|
3.40 gram (g)/meter(m)^2/hour (g/m^2/hr)
Standard Deviation 13.542
|
|
Change From Baseline in Trans-Epidermal Water Loss (TEWL) Measurements
Day 12
|
0.60 gram (g)/meter(m)^2/hour (g/m^2/hr)
Standard Deviation 7.181
|
0.47 gram (g)/meter(m)^2/hour (g/m^2/hr)
Standard Deviation 6.433
|
—
|
0.52 gram (g)/meter(m)^2/hour (g/m^2/hr)
Standard Deviation 5.468
|
1.21 gram (g)/meter(m)^2/hour (g/m^2/hr)
Standard Deviation 4.225
|
3.99 gram (g)/meter(m)^2/hour (g/m^2/hr)
Standard Deviation 6.655
|
3.66 gram (g)/meter(m)^2/hour (g/m^2/hr)
Standard Deviation 7.701
|
0.79 gram (g)/meter(m)^2/hour (g/m^2/hr)
Standard Deviation 8.074
|
|
Change From Baseline in Trans-Epidermal Water Loss (TEWL) Measurements
Day 13
|
1.69 gram (g)/meter(m)^2/hour (g/m^2/hr)
Standard Deviation 6.367
|
1.96 gram (g)/meter(m)^2/hour (g/m^2/hr)
Standard Deviation 6.642
|
3.97 gram (g)/meter(m)^2/hour (g/m^2/hr)
Standard Deviation 7.060
|
0.59 gram (g)/meter(m)^2/hour (g/m^2/hr)
Standard Deviation 5.786
|
4.05 gram (g)/meter(m)^2/hour (g/m^2/hr)
Standard Deviation 5.576
|
5.68 gram (g)/meter(m)^2/hour (g/m^2/hr)
Standard Deviation 11.911
|
2.61 gram (g)/meter(m)^2/hour (g/m^2/hr)
Standard Deviation 6.831
|
1.13 gram (g)/meter(m)^2/hour (g/m^2/hr)
Standard Deviation 6.594
|
|
Change From Baseline in Trans-Epidermal Water Loss (TEWL) Measurements
Day 14
|
0.91 gram (g)/meter(m)^2/hour (g/m^2/hr)
Standard Deviation 6.472
|
0.32 gram (g)/meter(m)^2/hour (g/m^2/hr)
Standard Deviation 5.469
|
—
|
0.55 gram (g)/meter(m)^2/hour (g/m^2/hr)
Standard Deviation 6.035
|
3.17 gram (g)/meter(m)^2/hour (g/m^2/hr)
Standard Deviation 4.744
|
4.33 gram (g)/meter(m)^2/hour (g/m^2/hr)
Standard Deviation 4.902
|
4.81 gram (g)/meter(m)^2/hour (g/m^2/hr)
Standard Deviation 12.362
|
1.97 gram (g)/meter(m)^2/hour (g/m^2/hr)
Standard Deviation 9.991
|
SECONDARY outcome
Timeframe: Day 0 (immediate after wound creation), Day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15 and 16Population: The Intent-to-Treat (ITT) set include all participants who received laser-induced wounds and started the study treatments. Here 'n' (number analyzed) included all evaluable participants analyzed at specified timepoints. As planned, for this outcome measure, the data was reported for each bandage separately.
Change from baseline in Clinical grading of wound healing parameter (erythema) was evaluated on a scale of 0 (no erythema) to 4 (severe erythema).
Outcome measures
| Measure |
Negative Control
n=36 Participants
Minor wounds were created on participant's forearms (four per arm) by a certified laser specialist. On the randomized wound site, no treatment was applied as the wound remained uncovered as negative control.
|
Marketed Adhesive Bandage
n=36 Participants
Minor wounds were created on participant's forearms (four per arm) by a certified laser specialist. On the randomized wound site, marketed adhesive bandage was applied. Bandages were changed daily/every other day until the wound reached a composite healing score of 8. The bandage was not left on after a composite healing score of 8 was achieved.
|
Marketed Adhesive Bandage IP-1 Benchmark Control 1
n=36 Participants
Minor wounds were created on participant's forearms (four per arm) by a certified laser specialist. On the randomized wound site, benchmark control 1 bandage was applied. Bandages were changed daily/every other day until the wound reached a composite healing score of 8. The bandage was not left on after a composite healing score of 8 was achieved.
|
Non-marketed Adhesive Bandage IP-Benchmark Control 2
n=36 Participants
Minor wounds were created on participant's forearms (four per arm) by a certified laser specialist. On the randomized wound site, benchmark control 2 bandage was applied. Bandages were changed daily/every other day until the wound reached a composite healing score of 8. The bandage was not left on after a composite healing score of 8 was achieved.
|
Non-marketed Adhesive Bandage IP #1
n=36 Participants
Minor wounds were created on participant's forearms (four per arm) by a certified laser specialist. On the randomized wound site, non-marketed IP#1 bandage was applied. Bandages were changed daily/every other day until the wound reached a composite healing score of 8. The bandage was not left on after a composite healing score of 8 was achieved.
|
Non-marketed Adhesive Bandage IP #2
n=36 Participants
Minor wounds were created on participant's forearms (four per arm) by a certified laser specialist. On the randomized wound site, non-marketed IP#2 bandage was applied. Bandages were changed daily/every other day until the wound reached a composite healing score of 8. The bandage was not left on after a composite healing score of 8 was achieved.
|
Non-marketed Adhesive Bandage IP #3
n=36 Participants
Minor wounds were created on participant's forearms (four per arm) by a certified laser specialist. On the randomized wound site, non-marketed IP#3 bandage was applied. Bandages were changed daily/every other day until the wound reached a composite healing score of 8. The bandage was not left on after a composite healing score of 8 was achieved.
|
Non-marketed Adhesive Bandage IP #4
n=36 Participants
Minor wounds were created on participant's forearms (four per arm) by a certified laser specialist. On the randomized wound site, non-marketed IP#4 bandage was applied. Bandages were changed daily/every other day until the wound reached a composite healing score of 8. The bandage was not left on after a composite healing score of 8 was achieved.
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Clinical Grading of Wound Healing Parameter - Erythema
Day 0
|
1.04 Scores on a scale
Standard Deviation 0.469
|
1.06 Scores on a scale
Standard Deviation 0.459
|
—
|
1.08 Scores on a scale
Standard Deviation 0.486
|
1.08 Scores on a scale
Standard Deviation 0.486
|
1.07 Scores on a scale
Standard Deviation 0.509
|
1.07 Scores on a scale
Standard Deviation 0.550
|
1.06 Scores on a scale
Standard Deviation 0.459
|
|
Change From Baseline in Clinical Grading of Wound Healing Parameter - Erythema
Day 1
|
3.03 Scores on a scale
Standard Deviation 0.686
|
2.28 Scores on a scale
Standard Deviation 0.760
|
—
|
2.07 Scores on a scale
Standard Deviation 0.645
|
2.13 Scores on a scale
Standard Deviation 0.740
|
2.10 Scores on a scale
Standard Deviation 0.791
|
2.42 Scores on a scale
Standard Deviation 0.849
|
2.03 Scores on a scale
Standard Deviation 0.632
|
|
Change From Baseline in Clinical Grading of Wound Healing Parameter - Erythema
Day 2
|
3.51 Scores on a scale
Standard Deviation 0.624
|
2.14 Scores on a scale
Standard Deviation 0.703
|
—
|
1.83 Scores on a scale
Standard Deviation 0.747
|
1.60 Scores on a scale
Standard Deviation 0.746
|
1.79 Scores on a scale
Standard Deviation 0.730
|
2.30 Scores on a scale
Standard Deviation 0.769
|
1.81 Scores on a scale
Standard Deviation 0.665
|
|
Change From Baseline in Clinical Grading of Wound Healing Parameter - Erythema
Day 3
|
3.50 Scores on a scale
Standard Deviation 0.630
|
2.00 Scores on a scale
Standard Deviation 0.795
|
1.62 Scores on a scale
Standard Deviation 0.650
|
1.67 Scores on a scale
Standard Deviation 0.696
|
1.29 Scores on a scale
Standard Deviation 0.740
|
1.63 Scores on a scale
Standard Deviation 0.668
|
2.40 Scores on a scale
Standard Deviation 0.705
|
1.74 Scores on a scale
Standard Deviation 0.657
|
|
Change From Baseline in Clinical Grading of Wound Healing Parameter - Erythema
Day 4
|
3.44 Scores on a scale
Standard Deviation 0.600
|
1.82 Scores on a scale
Standard Deviation 0.797
|
—
|
1.50 Scores on a scale
Standard Deviation 0.728
|
1.03 Scores on a scale
Standard Deviation 0.651
|
1.49 Scores on a scale
Standard Deviation 0.702
|
2.25 Scores on a scale
Standard Deviation 0.751
|
1.69 Scores on a scale
Standard Deviation 0.718
|
|
Change From Baseline in Clinical Grading of Wound Healing Parameter - Erythema
Day 5
|
3.09 Scores on a scale
Standard Deviation 0.691
|
1.72 Scores on a scale
Standard Deviation 0.698
|
1.21 Scores on a scale
Standard Deviation 0.687
|
1.51 Scores on a scale
Standard Deviation 0.668
|
0.69 Scores on a scale
Standard Deviation 0.508
|
1.53 Scores on a scale
Standard Deviation 0.651
|
2.09 Scores on a scale
Standard Deviation 0.633
|
1.76 Scores on a scale
Standard Deviation 0.710
|
|
Change From Baseline in Clinical Grading of Wound Healing Parameter - Erythema
Day 6
|
2.82 Scores on a scale
Standard Deviation 0.727
|
1.66 Scores on a scale
Standard Deviation 0.648
|
—
|
1.31 Scores on a scale
Standard Deviation 0.640
|
0.54 Scores on a scale
Standard Deviation 0.528
|
1.28 Scores on a scale
Standard Deviation 0.630
|
2.04 Scores on a scale
Standard Deviation 0.829
|
1.62 Scores on a scale
Standard Deviation 0.729
|
|
Change From Baseline in Clinical Grading of Wound Healing Parameter - Erythema
Day 7
|
2.41 Scores on a scale
Standard Deviation 0.883
|
1.65 Scores on a scale
Standard Deviation 0.764
|
0.79 Scores on a scale
Standard Deviation 0.676
|
1.41 Scores on a scale
Standard Deviation 0.645
|
0.56 Scores on a scale
Standard Deviation 0.519
|
1.31 Scores on a scale
Standard Deviation 0.779
|
1.94 Scores on a scale
Standard Deviation 0.736
|
1.75 Scores on a scale
Standard Deviation 0.846
|
|
Change From Baseline in Clinical Grading of Wound Healing Parameter - Erythema
Day 8
|
2.33 Scores on a scale
Standard Deviation 0.747
|
1.45 Scores on a scale
Standard Deviation 0.754
|
—
|
1.24 Scores on a scale
Standard Deviation 0.675
|
0.62 Scores on a scale
Standard Deviation 0.587
|
1.17 Scores on a scale
Standard Deviation 0.633
|
1.68 Scores on a scale
Standard Deviation 0.694
|
1.89 Scores on a scale
Standard Deviation 0.726
|
|
Change From Baseline in Clinical Grading of Wound Healing Parameter - Erythema
Day 9
|
1.98 Scores on a scale
Standard Deviation 0.805
|
1.38 Scores on a scale
Standard Deviation 0.696
|
0.79 Scores on a scale
Standard Deviation 0.685
|
0.98 Scores on a scale
Standard Deviation 0.523
|
0.42 Scores on a scale
Standard Deviation 0.378
|
0.95 Scores on a scale
Standard Deviation 0.474
|
1.44 Scores on a scale
Standard Deviation 0.560
|
1.67 Scores on a scale
Standard Deviation 0.736
|
|
Change From Baseline in Clinical Grading of Wound Healing Parameter - Erythema
Day 10
|
1.88 Scores on a scale
Standard Deviation 0.839
|
1.14 Scores on a scale
Standard Deviation 0.628
|
—
|
0.88 Scores on a scale
Standard Deviation 0.500
|
0.44 Scores on a scale
Standard Deviation 0.390
|
0.86 Scores on a scale
Standard Deviation 0.462
|
1.15 Scores on a scale
Standard Deviation 0.569
|
1.52 Scores on a scale
Standard Deviation 0.798
|
|
Change From Baseline in Clinical Grading of Wound Healing Parameter - Erythema
Day 11
|
1.67 Scores on a scale
Standard Deviation 0.845
|
1.02 Scores on a scale
Standard Deviation 0.492
|
0.56 Scores on a scale
Standard Deviation 0.390
|
0.86 Scores on a scale
Standard Deviation 0.472
|
0.39 Scores on a scale
Standard Deviation 0.370
|
0.80 Scores on a scale
Standard Deviation 0.455
|
1.13 Scores on a scale
Standard Deviation 0.511
|
1.41 Scores on a scale
Standard Deviation 0.798
|
|
Change From Baseline in Clinical Grading of Wound Healing Parameter - Erythema
Day 12
|
1.38 Scores on a scale
Standard Deviation 0.650
|
0.88 Scores on a scale
Standard Deviation 0.662
|
—
|
0.68 Scores on a scale
Standard Deviation 0.411
|
0.32 Scores on a scale
Standard Deviation 0.302
|
0.67 Scores on a scale
Standard Deviation 0.433
|
0.91 Scores on a scale
Standard Deviation 0.538
|
1.25 Scores on a scale
Standard Deviation 0.660
|
|
Change From Baseline in Clinical Grading of Wound Healing Parameter - Erythema
Day 13
|
1.20 Scores on a scale
Standard Deviation 0.624
|
0.70 Scores on a scale
Standard Deviation 0.450
|
0.41 Scores on a scale
Standard Deviation 0.384
|
0.61 Scores on a scale
Standard Deviation 0.410
|
0.26 Scores on a scale
Standard Deviation 0.309
|
0.58 Scores on a scale
Standard Deviation 0.404
|
0.94 Scores on a scale
Standard Deviation 0.543
|
1.16 Scores on a scale
Standard Deviation 0.665
|
|
Change From Baseline in Clinical Grading of Wound Healing Parameter - Erythema
Day 14
|
1.23 Scores on a scale
Standard Deviation 0.574
|
0.65 Scores on a scale
Standard Deviation 0.537
|
—
|
0.53 Scores on a scale
Standard Deviation 0.394
|
0.27 Scores on a scale
Standard Deviation 0.333
|
0.42 Scores on a scale
Standard Deviation 0.383
|
0.95 Scores on a scale
Standard Deviation 0.567
|
1.05 Scores on a scale
Standard Deviation 0.601
|
|
Change From Baseline in Clinical Grading of Wound Healing Parameter - Erythema
Day 15
|
1.09 Scores on a scale
Standard Deviation 0.537
|
0.58 Scores on a scale
Standard Deviation 0.417
|
0.30 Scores on a scale
Standard Deviation 0.329
|
0.48 Scores on a scale
Standard Deviation 0.385
|
0.17 Scores on a scale
Standard Deviation 0.239
|
0.38 Scores on a scale
Standard Deviation 0.311
|
0.72 Scores on a scale
Standard Deviation 0.446
|
0.92 Scores on a scale
Standard Deviation 0.555
|
|
Change From Baseline in Clinical Grading of Wound Healing Parameter - Erythema
Day 16
|
1.08 Scores on a scale
Standard Deviation 0.486
|
0.56 Scores on a scale
Standard Deviation 0.480
|
0.38 Scores on a scale
Standard Deviation 0.331
|
0.47 Scores on a scale
Standard Deviation 0.374
|
0.17 Scores on a scale
Standard Deviation 0.239
|
0.36 Scores on a scale
Standard Deviation 0.364
|
0.79 Scores on a scale
Standard Deviation 0.535
|
0.86 Scores on a scale
Standard Deviation 0.650
|
SECONDARY outcome
Timeframe: Day 0 (immediate after wound creation), Day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15 and 16Population: The Intent-to-Treat (ITT) set include all participants who received laser-induced wounds and started the study treatments. Here 'n' (number analyzed) included all evaluable participants analyzed at specified timepoints. As planned, for this outcome measure, the data was reported for each bandage separately.
Change from baseline in Clinical grading of wound healing parameter (edema) was evaluated on a scale of 0 (no edema) to 4 (severe edema).
Outcome measures
| Measure |
Negative Control
n=36 Participants
Minor wounds were created on participant's forearms (four per arm) by a certified laser specialist. On the randomized wound site, no treatment was applied as the wound remained uncovered as negative control.
|
Marketed Adhesive Bandage
n=36 Participants
Minor wounds were created on participant's forearms (four per arm) by a certified laser specialist. On the randomized wound site, marketed adhesive bandage was applied. Bandages were changed daily/every other day until the wound reached a composite healing score of 8. The bandage was not left on after a composite healing score of 8 was achieved.
|
Marketed Adhesive Bandage IP-1 Benchmark Control 1
n=36 Participants
Minor wounds were created on participant's forearms (four per arm) by a certified laser specialist. On the randomized wound site, benchmark control 1 bandage was applied. Bandages were changed daily/every other day until the wound reached a composite healing score of 8. The bandage was not left on after a composite healing score of 8 was achieved.
|
Non-marketed Adhesive Bandage IP-Benchmark Control 2
n=36 Participants
Minor wounds were created on participant's forearms (four per arm) by a certified laser specialist. On the randomized wound site, benchmark control 2 bandage was applied. Bandages were changed daily/every other day until the wound reached a composite healing score of 8. The bandage was not left on after a composite healing score of 8 was achieved.
|
Non-marketed Adhesive Bandage IP #1
n=36 Participants
Minor wounds were created on participant's forearms (four per arm) by a certified laser specialist. On the randomized wound site, non-marketed IP#1 bandage was applied. Bandages were changed daily/every other day until the wound reached a composite healing score of 8. The bandage was not left on after a composite healing score of 8 was achieved.
|
Non-marketed Adhesive Bandage IP #2
n=36 Participants
Minor wounds were created on participant's forearms (four per arm) by a certified laser specialist. On the randomized wound site, non-marketed IP#2 bandage was applied. Bandages were changed daily/every other day until the wound reached a composite healing score of 8. The bandage was not left on after a composite healing score of 8 was achieved.
|
Non-marketed Adhesive Bandage IP #3
n=36 Participants
Minor wounds were created on participant's forearms (four per arm) by a certified laser specialist. On the randomized wound site, non-marketed IP#3 bandage was applied. Bandages were changed daily/every other day until the wound reached a composite healing score of 8. The bandage was not left on after a composite healing score of 8 was achieved.
|
Non-marketed Adhesive Bandage IP #4
n=36 Participants
Minor wounds were created on participant's forearms (four per arm) by a certified laser specialist. On the randomized wound site, non-marketed IP#4 bandage was applied. Bandages were changed daily/every other day until the wound reached a composite healing score of 8. The bandage was not left on after a composite healing score of 8 was achieved.
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Clinical Grading of Wound Healing Parameter - Edema
Day 6
|
0.00 Scores on a scale
Standard Deviation 0.000
|
0.00 Scores on a scale
Standard Deviation 0.000
|
—
|
0.00 Scores on a scale
Standard Deviation 0.000
|
0.00 Scores on a scale
Standard Deviation 0.000
|
0.04 Scores on a scale
Standard Deviation 0.257
|
0.00 Scores on a scale
Standard Deviation 0.000
|
0.00 Scores on a scale
Standard Deviation 0.000
|
|
Change From Baseline in Clinical Grading of Wound Healing Parameter - Edema
Day 7
|
0.00 Scores on a scale
Standard Deviation 0.000
|
0.00 Scores on a scale
Standard Deviation 0.000
|
0.00 Scores on a scale
Standard Deviation 0.000
|
0.03 Scores on a scale
Standard Deviation 0.171
|
0.00 Scores on a scale
Standard Deviation 0.000
|
0.01 Scores on a scale
Standard Deviation 0.086
|
0.00 Scores on a scale
Standard Deviation 0.000
|
0.00 Scores on a scale
Standard Deviation 0.000
|
|
Change From Baseline in Clinical Grading of Wound Healing Parameter - Edema
Day 16
|
0.00 Scores on a scale
Standard Deviation 0.000
|
0.00 Scores on a scale
Standard Deviation 0.000
|
0.00 Scores on a scale
Standard Deviation 0.000
|
0.00 Scores on a scale
Standard Deviation 0.000
|
0.00 Scores on a scale
Standard Deviation 0.000
|
0.00 Scores on a scale
Standard Deviation 0.000
|
0.02 Scores on a scale
Standard Deviation 0.094
|
0.00 Scores on a scale
Standard Deviation 0.000
|
|
Change From Baseline in Clinical Grading of Wound Healing Parameter - Edema
Day 0
|
0.22 Scores on a scale
Standard Deviation 0.326
|
0.21 Scores on a scale
Standard Deviation 0.325
|
—
|
0.22 Scores on a scale
Standard Deviation 0.347
|
0.22 Scores on a scale
Standard Deviation 0.326
|
0.26 Scores on a scale
Standard Deviation 0.439
|
0.28 Scores on a scale
Standard Deviation 0.454
|
0.22 Scores on a scale
Standard Deviation 0.347
|
|
Change From Baseline in Clinical Grading of Wound Healing Parameter - Edema
Day 1
|
0.42 Scores on a scale
Standard Deviation 0.439
|
0.01 Scores on a scale
Standard Deviation 0.083
|
—
|
0.00 Scores on a scale
Standard Deviation 0.000
|
0.00 Scores on a scale
Standard Deviation 0.000
|
0.00 Scores on a scale
Standard Deviation 0.000
|
0.00 Scores on a scale
Standard Deviation 0.000
|
0.00 Scores on a scale
Standard Deviation 0.000
|
|
Change From Baseline in Clinical Grading of Wound Healing Parameter - Edema
Day 2
|
0.16 Scores on a scale
Standard Deviation 0.291
|
0.00 Scores on a scale
Standard Deviation 0.000
|
—
|
0.01 Scores on a scale
Standard Deviation 0.085
|
0.00 Scores on a scale
Standard Deviation 0.000
|
0.00 Scores on a scale
Standard Deviation 0.000
|
0.00 Scores on a scale
Standard Deviation 0.000
|
0.01 Scores on a scale
Standard Deviation 0.085
|
|
Change From Baseline in Clinical Grading of Wound Healing Parameter - Edema
Day 3
|
0.09 Scores on a scale
Standard Deviation 0.191
|
0.00 Scores on a scale
Standard Deviation 0.000
|
0.00 Scores on a scale
Standard Deviation 0.000
|
0.00 Scores on a scale
Standard Deviation 0.000
|
0.00 Scores on a scale
Standard Deviation 0.000
|
0.00 Scores on a scale
Standard Deviation 0.000
|
0.00 Scores on a scale
Standard Deviation 0.000
|
0.01 Scores on a scale
Standard Deviation 0.085
|
|
Change From Baseline in Clinical Grading of Wound Healing Parameter - Edema
Day 4
|
0.00 Scores on a scale
Standard Deviation 0.000
|
0.00 Scores on a scale
Standard Deviation 0.000
|
—
|
0.00 Scores on a scale
Standard Deviation 0.000
|
0.00 Scores on a scale
Standard Deviation 0.000
|
0.00 Scores on a scale
Standard Deviation 0.000
|
0.00 Scores on a scale
Standard Deviation 0.000
|
0.00 Scores on a scale
Standard Deviation 0.000
|
|
Change From Baseline in Clinical Grading of Wound Healing Parameter - Edema
Day 5
|
0.00 Scores on a scale
Standard Deviation 0.000
|
0.00 Scores on a scale
Standard Deviation 0.000
|
0.03 Scores on a scale
Standard Deviation 0.171
|
0.00 Scores on a scale
Standard Deviation 0.000
|
0.00 Scores on a scale
Standard Deviation 0.000
|
0.00 Scores on a scale
Standard Deviation 0.000
|
0.00 Scores on a scale
Standard Deviation 0.000
|
0.00 Scores on a scale
Standard Deviation 0.000
|
|
Change From Baseline in Clinical Grading of Wound Healing Parameter - Edema
Day 8
|
0.00 Scores on a scale
Standard Deviation 0.000
|
0.00 Scores on a scale
Standard Deviation 0.000
|
—
|
0.02 Scores on a scale
Standard Deviation 0.087
|
0.00 Scores on a scale
Standard Deviation 0.000
|
0.00 Scores on a scale
Standard Deviation 0.000
|
0.00 Scores on a scale
Standard Deviation 0.000
|
0.00 Scores on a scale
Standard Deviation 0.000
|
|
Change From Baseline in Clinical Grading of Wound Healing Parameter - Edema
Day 9
|
0.00 Scores on a scale
Standard Deviation 0.000
|
0.00 Scores on a scale
Standard Deviation 0.000
|
0.00 Scores on a scale
Standard Deviation 0.000
|
0.02 Scores on a scale
Standard Deviation 0.087
|
0.00 Scores on a scale
Standard Deviation 0.000
|
0.03 Scores on a scale
Standard Deviation 0.174
|
0.00 Scores on a scale
Standard Deviation 0.000
|
0.00 Scores on a scale
Standard Deviation 0.000
|
|
Change From Baseline in Clinical Grading of Wound Healing Parameter - Edema
Day 10
|
0.00 Scores on a scale
Standard Deviation 0.000
|
0.00 Scores on a scale
Standard Deviation 0.000
|
—
|
0.00 Scores on a scale
Standard Deviation 0.000
|
0.00 Scores on a scale
Standard Deviation 0.000
|
0.00 Scores on a scale
Standard Deviation 0.000
|
0.00 Scores on a scale
Standard Deviation 0.000
|
0.00 Scores on a scale
Standard Deviation 0.000
|
|
Change From Baseline in Clinical Grading of Wound Healing Parameter - Edema
Day 11
|
0.00 Scores on a scale
Standard Deviation 0.000
|
0.00 Scores on a scale
Standard Deviation 0.000
|
0.00 Scores on a scale
Standard Deviation 0.000
|
0.00 Scores on a scale
Standard Deviation 0.000
|
0.00 Scores on a scale
Standard Deviation 0.000
|
0.00 Scores on a scale
Standard Deviation 0.000
|
0.00 Scores on a scale
Standard Deviation 0.000
|
0.00 Scores on a scale
Standard Deviation 0.000
|
|
Change From Baseline in Clinical Grading of Wound Healing Parameter - Edema
Day 12
|
0.00 Scores on a scale
Standard Deviation 0.000
|
0.00 Scores on a scale
Standard Deviation 0.000
|
—
|
0.00 Scores on a scale
Standard Deviation 0.000
|
0.00 Scores on a scale
Standard Deviation 0.000
|
0.00 Scores on a scale
Standard Deviation 0.000
|
0.02 Scores on a scale
Standard Deviation 0.096
|
0.00 Scores on a scale
Standard Deviation 0.000
|
|
Change From Baseline in Clinical Grading of Wound Healing Parameter - Edema
Day 13
|
0.00 Scores on a scale
Standard Deviation 0.000
|
0.00 Scores on a scale
Standard Deviation 0.000
|
0.00 Scores on a scale
Standard Deviation 0.000
|
0.00 Scores on a scale
Standard Deviation 0.000
|
0.00 Scores on a scale
Standard Deviation 0.000
|
0.00 Scores on a scale
Standard Deviation 0.000
|
0.04 Scores on a scale
Standard Deviation 0.192
|
0.00 Scores on a scale
Standard Deviation 0.000
|
|
Change From Baseline in Clinical Grading of Wound Healing Parameter - Edema
Day 14
|
0.00 Scores on a scale
Standard Deviation 0.000
|
0.02 Scores on a scale
Standard Deviation 0.087
|
—
|
0.00 Scores on a scale
Standard Deviation 0.000
|
0.00 Scores on a scale
Standard Deviation 0.000
|
0.00 Scores on a scale
Standard Deviation 0.000
|
0.04 Scores on a scale
Standard Deviation 0.189
|
0.00 Scores on a scale
Standard Deviation 0.000
|
|
Change From Baseline in Clinical Grading of Wound Healing Parameter - Edema
Day 15
|
0.00 Scores on a scale
Standard Deviation 0.000
|
0.00 Scores on a scale
Standard Deviation 0.000
|
0.00 Scores on a scale
Standard Deviation 0.000
|
0.00 Scores on a scale
Standard Deviation 0.000
|
0.00 Scores on a scale
Standard Deviation 0.000
|
0.00 Scores on a scale
Standard Deviation 0.000
|
0.00 Scores on a scale
Standard Deviation 0.000
|
0.00 Scores on a scale
Standard Deviation 0.000
|
SECONDARY outcome
Timeframe: Baseline and Day 28Population: The Intent-to-Treat (ITT) set include all participants who received laser-induced wounds and started the study treatments. Here 'n' (number analyzed) included all evaluable participants analyzed at specified timepoints. As planned, for this outcome measure, the data was reported for each bandage separately.
Change from baseline in composite scar score was reported. It was calculated as the sum of the individual parameters on the Manchester Scar Scale (Color ranges 1 \[perfect\] to 4 \[gross mismatch\]), Finish ranges 1 \[matte\] to 2 \[shiny\], Contour ranges 1 \[Flush with surrounding skin\] to 4 \[keloid\], Distortion ranges 1 \[none\] to 4 \[severe\] and Texture ranges 1 \[normal\] to 4 \[hard\]). Composite Scar Scores range from 5 to 18, with 5 representing clinically best scars and 18 representing clinically worst scars.
Outcome measures
| Measure |
Negative Control
n=33 Participants
Minor wounds were created on participant's forearms (four per arm) by a certified laser specialist. On the randomized wound site, no treatment was applied as the wound remained uncovered as negative control.
|
Marketed Adhesive Bandage
n=33 Participants
Minor wounds were created on participant's forearms (four per arm) by a certified laser specialist. On the randomized wound site, marketed adhesive bandage was applied. Bandages were changed daily/every other day until the wound reached a composite healing score of 8. The bandage was not left on after a composite healing score of 8 was achieved.
|
Marketed Adhesive Bandage IP-1 Benchmark Control 1
n=33 Participants
Minor wounds were created on participant's forearms (four per arm) by a certified laser specialist. On the randomized wound site, benchmark control 1 bandage was applied. Bandages were changed daily/every other day until the wound reached a composite healing score of 8. The bandage was not left on after a composite healing score of 8 was achieved.
|
Non-marketed Adhesive Bandage IP-Benchmark Control 2
n=33 Participants
Minor wounds were created on participant's forearms (four per arm) by a certified laser specialist. On the randomized wound site, benchmark control 2 bandage was applied. Bandages were changed daily/every other day until the wound reached a composite healing score of 8. The bandage was not left on after a composite healing score of 8 was achieved.
|
Non-marketed Adhesive Bandage IP #1
n=33 Participants
Minor wounds were created on participant's forearms (four per arm) by a certified laser specialist. On the randomized wound site, non-marketed IP#1 bandage was applied. Bandages were changed daily/every other day until the wound reached a composite healing score of 8. The bandage was not left on after a composite healing score of 8 was achieved.
|
Non-marketed Adhesive Bandage IP #2
n=33 Participants
Minor wounds were created on participant's forearms (four per arm) by a certified laser specialist. On the randomized wound site, non-marketed IP#2 bandage was applied. Bandages were changed daily/every other day until the wound reached a composite healing score of 8. The bandage was not left on after a composite healing score of 8 was achieved.
|
Non-marketed Adhesive Bandage IP #3
n=33 Participants
Minor wounds were created on participant's forearms (four per arm) by a certified laser specialist. On the randomized wound site, non-marketed IP#3 bandage was applied. Bandages were changed daily/every other day until the wound reached a composite healing score of 8. The bandage was not left on after a composite healing score of 8 was achieved.
|
Non-marketed Adhesive Bandage IP #4
n=33 Participants
Minor wounds were created on participant's forearms (four per arm) by a certified laser specialist. On the randomized wound site, non-marketed IP#4 bandage was applied. Bandages were changed daily/every other day until the wound reached a composite healing score of 8. The bandage was not left on after a composite healing score of 8 was achieved.
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Composite Scar Score
|
2.09 Scores on a scale
Standard Deviation 1.548
|
0.61 Scores on a scale
Standard Deviation 0.496
|
0.33 Scores on a scale
Standard Deviation 0.645
|
0.42 Scores on a scale
Standard Deviation 0.502
|
0.24 Scores on a scale
Standard Deviation 0.435
|
0.30 Scores on a scale
Standard Deviation 0.467
|
0.88 Scores on a scale
Standard Deviation 0.893
|
1.18 Scores on a scale
Standard Deviation 1.103
|
SECONDARY outcome
Timeframe: Baseline, Day 1, 2, 3 and 4Population: The Intent-to-Treat (ITT) set include all participants who received laser-induced wounds and started the study treatments. Here 'n' (number analyzed) included all evaluable participants analyzed at specified timepoints. As planned, for this outcome measure, the data was reported for each bandage separately.
Change from baseline in painful score based on participants self-assessment questionnaire score (question 1) was reported. Participants were asked to rate each wound for pain/soreness in resting position as score from 0 (no pain) to 10 (severe pain).
Outcome measures
| Measure |
Negative Control
n=36 Participants
Minor wounds were created on participant's forearms (four per arm) by a certified laser specialist. On the randomized wound site, no treatment was applied as the wound remained uncovered as negative control.
|
Marketed Adhesive Bandage
n=36 Participants
Minor wounds were created on participant's forearms (four per arm) by a certified laser specialist. On the randomized wound site, marketed adhesive bandage was applied. Bandages were changed daily/every other day until the wound reached a composite healing score of 8. The bandage was not left on after a composite healing score of 8 was achieved.
|
Marketed Adhesive Bandage IP-1 Benchmark Control 1
n=36 Participants
Minor wounds were created on participant's forearms (four per arm) by a certified laser specialist. On the randomized wound site, benchmark control 1 bandage was applied. Bandages were changed daily/every other day until the wound reached a composite healing score of 8. The bandage was not left on after a composite healing score of 8 was achieved.
|
Non-marketed Adhesive Bandage IP-Benchmark Control 2
n=36 Participants
Minor wounds were created on participant's forearms (four per arm) by a certified laser specialist. On the randomized wound site, benchmark control 2 bandage was applied. Bandages were changed daily/every other day until the wound reached a composite healing score of 8. The bandage was not left on after a composite healing score of 8 was achieved.
|
Non-marketed Adhesive Bandage IP #1
n=36 Participants
Minor wounds were created on participant's forearms (four per arm) by a certified laser specialist. On the randomized wound site, non-marketed IP#1 bandage was applied. Bandages were changed daily/every other day until the wound reached a composite healing score of 8. The bandage was not left on after a composite healing score of 8 was achieved.
|
Non-marketed Adhesive Bandage IP #2
n=36 Participants
Minor wounds were created on participant's forearms (four per arm) by a certified laser specialist. On the randomized wound site, non-marketed IP#2 bandage was applied. Bandages were changed daily/every other day until the wound reached a composite healing score of 8. The bandage was not left on after a composite healing score of 8 was achieved.
|
Non-marketed Adhesive Bandage IP #3
n=36 Participants
Minor wounds were created on participant's forearms (four per arm) by a certified laser specialist. On the randomized wound site, non-marketed IP#3 bandage was applied. Bandages were changed daily/every other day until the wound reached a composite healing score of 8. The bandage was not left on after a composite healing score of 8 was achieved.
|
Non-marketed Adhesive Bandage IP #4
n=36 Participants
Minor wounds were created on participant's forearms (four per arm) by a certified laser specialist. On the randomized wound site, non-marketed IP#4 bandage was applied. Bandages were changed daily/every other day until the wound reached a composite healing score of 8. The bandage was not left on after a composite healing score of 8 was achieved.
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Painful Score With Arm Resting by Side
Day 3
|
-0.93 Scores on a scale
Standard Deviation 1.439
|
-0.56 Scores on a scale
Standard Deviation 1.188
|
-0.63 Scores on a scale
Standard Deviation 1.305
|
-0.67 Scores on a scale
Standard Deviation 1.177
|
-0.67 Scores on a scale
Standard Deviation 1.330
|
-0.67 Scores on a scale
Standard Deviation 1.387
|
-0.67 Scores on a scale
Standard Deviation 1.301
|
-0.78 Scores on a scale
Standard Deviation 1.649
|
|
Change From Baseline in Painful Score With Arm Resting by Side
Day 4
|
-0.96 Scores on a scale
Standard Deviation 1.400
|
-0.63 Scores on a scale
Standard Deviation 1.115
|
-0.67 Scores on a scale
Standard Deviation 1.271
|
-0.70 Scores on a scale
Standard Deviation 1.137
|
-0.63 Scores on a scale
Standard Deviation 1.391
|
-0.74 Scores on a scale
Standard Deviation 1.318
|
-0.70 Scores on a scale
Standard Deviation 1.265
|
-0.81 Scores on a scale
Standard Deviation 1.570
|
|
Change From Baseline in Painful Score With Arm Resting by Side
Day 1
|
-0.61 Scores on a scale
Standard Deviation 1.286
|
-0.32 Scores on a scale
Standard Deviation 0.983
|
-0.46 Scores on a scale
Standard Deviation 0.999
|
-0.46 Scores on a scale
Standard Deviation 0.922
|
-0.43 Scores on a scale
Standard Deviation 1.034
|
-0.54 Scores on a scale
Standard Deviation 1.071
|
-0.39 Scores on a scale
Standard Deviation 1.031
|
-0.68 Scores on a scale
Standard Deviation 1.219
|
|
Change From Baseline in Painful Score With Arm Resting by Side
Day 2
|
-0.85 Scores on a scale
Standard Deviation 1.317
|
-0.42 Scores on a scale
Standard Deviation 1.027
|
-0.50 Scores on a scale
Standard Deviation 1.140
|
-0.37 Scores on a scale
Standard Deviation 1.334
|
-0.54 Scores on a scale
Standard Deviation 1.174
|
-0.44 Scores on a scale
Standard Deviation 1.368
|
-0.54 Scores on a scale
Standard Deviation 1.140
|
-0.77 Scores on a scale
Standard Deviation 1.366
|
SECONDARY outcome
Timeframe: Baseline, Day 1, 2, 3 and 4Population: The Intent-to-Treat (ITT) set include all participants who received laser-induced wounds and started the study treatments. Here 'n' (number analyzed) included all evaluable participants analyzed at specified timepoints. As planned, for this outcome measure, the data was reported for each bandage separately.
Change from baseline in Painful Score based on participants self-assessment questionnaire score (question 3) was reported. Participants were asked to rate each wound for pain/soreness in normal position as score from 0 (no pain) to 10 (severe pain).
Outcome measures
| Measure |
Negative Control
n=36 Participants
Minor wounds were created on participant's forearms (four per arm) by a certified laser specialist. On the randomized wound site, no treatment was applied as the wound remained uncovered as negative control.
|
Marketed Adhesive Bandage
n=36 Participants
Minor wounds were created on participant's forearms (four per arm) by a certified laser specialist. On the randomized wound site, marketed adhesive bandage was applied. Bandages were changed daily/every other day until the wound reached a composite healing score of 8. The bandage was not left on after a composite healing score of 8 was achieved.
|
Marketed Adhesive Bandage IP-1 Benchmark Control 1
n=36 Participants
Minor wounds were created on participant's forearms (four per arm) by a certified laser specialist. On the randomized wound site, benchmark control 1 bandage was applied. Bandages were changed daily/every other day until the wound reached a composite healing score of 8. The bandage was not left on after a composite healing score of 8 was achieved.
|
Non-marketed Adhesive Bandage IP-Benchmark Control 2
n=36 Participants
Minor wounds were created on participant's forearms (four per arm) by a certified laser specialist. On the randomized wound site, benchmark control 2 bandage was applied. Bandages were changed daily/every other day until the wound reached a composite healing score of 8. The bandage was not left on after a composite healing score of 8 was achieved.
|
Non-marketed Adhesive Bandage IP #1
n=36 Participants
Minor wounds were created on participant's forearms (four per arm) by a certified laser specialist. On the randomized wound site, non-marketed IP#1 bandage was applied. Bandages were changed daily/every other day until the wound reached a composite healing score of 8. The bandage was not left on after a composite healing score of 8 was achieved.
|
Non-marketed Adhesive Bandage IP #2
n=36 Participants
Minor wounds were created on participant's forearms (four per arm) by a certified laser specialist. On the randomized wound site, non-marketed IP#2 bandage was applied. Bandages were changed daily/every other day until the wound reached a composite healing score of 8. The bandage was not left on after a composite healing score of 8 was achieved.
|
Non-marketed Adhesive Bandage IP #3
n=36 Participants
Minor wounds were created on participant's forearms (four per arm) by a certified laser specialist. On the randomized wound site, non-marketed IP#3 bandage was applied. Bandages were changed daily/every other day until the wound reached a composite healing score of 8. The bandage was not left on after a composite healing score of 8 was achieved.
|
Non-marketed Adhesive Bandage IP #4
n=36 Participants
Minor wounds were created on participant's forearms (four per arm) by a certified laser specialist. On the randomized wound site, non-marketed IP#4 bandage was applied. Bandages were changed daily/every other day until the wound reached a composite healing score of 8. The bandage was not left on after a composite healing score of 8 was achieved.
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Painful Score With Arm in Normal Motion
Day 1
|
-0.46 Scores on a scale
Standard Deviation 1.319
|
-0.14 Scores on a scale
Standard Deviation 0.932
|
-0.29 Scores on a scale
Standard Deviation 0.937
|
-0.32 Scores on a scale
Standard Deviation 0.863
|
-0.29 Scores on a scale
Standard Deviation 0.976
|
-0.32 Scores on a scale
Standard Deviation 0.945
|
-0.32 Scores on a scale
Standard Deviation 0.945
|
-0.43 Scores on a scale
Standard Deviation 1.069
|
|
Change From Baseline in Painful Score With Arm in Normal Motion
Day 2
|
-0.77 Scores on a scale
Standard Deviation 1.177
|
-0.35 Scores on a scale
Standard Deviation 0.797
|
-0.42 Scores on a scale
Standard Deviation 0.857
|
-0.33 Scores on a scale
Standard Deviation 1.000
|
-0.50 Scores on a scale
Standard Deviation 0.906
|
-0.33 Scores on a scale
Standard Deviation 1.074
|
-0.50 Scores on a scale
Standard Deviation 0.860
|
-0.62 Scores on a scale
Standard Deviation 1.023
|
|
Change From Baseline in Painful Score With Arm in Normal Motion
Day 3
|
-0.74 Scores on a scale
Standard Deviation 1.318
|
-0.33 Scores on a scale
Standard Deviation 1.000
|
-0.44 Scores on a scale
Standard Deviation 1.086
|
-0.44 Scores on a scale
Standard Deviation 1.013
|
-0.52 Scores on a scale
Standard Deviation 1.122
|
-0.44 Scores on a scale
Standard Deviation 1.121
|
-0.52 Scores on a scale
Standard Deviation 1.087
|
-0.52 Scores on a scale
Standard Deviation 1.397
|
|
Change From Baseline in Painful Score With Arm in Normal Motion
Day 4
|
-0.78 Scores on a scale
Standard Deviation 1.251
|
-0.44 Scores on a scale
Standard Deviation 0.892
|
-0.48 Scores on a scale
Standard Deviation 1.014
|
-0.52 Scores on a scale
Standard Deviation 0.893
|
-0.48 Scores on a scale
Standard Deviation 1.156
|
-0.52 Scores on a scale
Standard Deviation 1.014
|
-0.56 Scores on a scale
Standard Deviation 1.013
|
-0.56 Scores on a scale
Standard Deviation 1.281
|
SECONDARY outcome
Timeframe: Baseline, Day 1, 2, 3 and 4Population: The Intent-to-Treat (ITT) set include all participants who received laser-induced wounds and started the study treatments. Here 'n' (number analyzed) included all evaluable participants analyzed at specified timepoints. As planned, for this outcome measure, the data was reported for each bandage separately.
Change from baseline in itchy score based on participants self-assessment questionnaire score (question 5) was reported. Participants were asked to rate each wound for itchiness as score from 0 (no itch) to 10 (severe itch).
Outcome measures
| Measure |
Negative Control
n=36 Participants
Minor wounds were created on participant's forearms (four per arm) by a certified laser specialist. On the randomized wound site, no treatment was applied as the wound remained uncovered as negative control.
|
Marketed Adhesive Bandage
n=36 Participants
Minor wounds were created on participant's forearms (four per arm) by a certified laser specialist. On the randomized wound site, marketed adhesive bandage was applied. Bandages were changed daily/every other day until the wound reached a composite healing score of 8. The bandage was not left on after a composite healing score of 8 was achieved.
|
Marketed Adhesive Bandage IP-1 Benchmark Control 1
n=36 Participants
Minor wounds were created on participant's forearms (four per arm) by a certified laser specialist. On the randomized wound site, benchmark control 1 bandage was applied. Bandages were changed daily/every other day until the wound reached a composite healing score of 8. The bandage was not left on after a composite healing score of 8 was achieved.
|
Non-marketed Adhesive Bandage IP-Benchmark Control 2
n=36 Participants
Minor wounds were created on participant's forearms (four per arm) by a certified laser specialist. On the randomized wound site, benchmark control 2 bandage was applied. Bandages were changed daily/every other day until the wound reached a composite healing score of 8. The bandage was not left on after a composite healing score of 8 was achieved.
|
Non-marketed Adhesive Bandage IP #1
n=36 Participants
Minor wounds were created on participant's forearms (four per arm) by a certified laser specialist. On the randomized wound site, non-marketed IP#1 bandage was applied. Bandages were changed daily/every other day until the wound reached a composite healing score of 8. The bandage was not left on after a composite healing score of 8 was achieved.
|
Non-marketed Adhesive Bandage IP #2
n=36 Participants
Minor wounds were created on participant's forearms (four per arm) by a certified laser specialist. On the randomized wound site, non-marketed IP#2 bandage was applied. Bandages were changed daily/every other day until the wound reached a composite healing score of 8. The bandage was not left on after a composite healing score of 8 was achieved.
|
Non-marketed Adhesive Bandage IP #3
n=36 Participants
Minor wounds were created on participant's forearms (four per arm) by a certified laser specialist. On the randomized wound site, non-marketed IP#3 bandage was applied. Bandages were changed daily/every other day until the wound reached a composite healing score of 8. The bandage was not left on after a composite healing score of 8 was achieved.
|
Non-marketed Adhesive Bandage IP #4
n=36 Participants
Minor wounds were created on participant's forearms (four per arm) by a certified laser specialist. On the randomized wound site, non-marketed IP#4 bandage was applied. Bandages were changed daily/every other day until the wound reached a composite healing score of 8. The bandage was not left on after a composite healing score of 8 was achieved.
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Itchy Score
Day 4
|
-0.15 Scores on a scale
Standard Deviation 1.854
|
0.00 Scores on a scale
Standard Deviation 1.359
|
-0.11 Scores on a scale
Standard Deviation 1.826
|
-0.22 Scores on a scale
Standard Deviation 1.847
|
-0.26 Scores on a scale
Standard Deviation 1.789
|
-0.11 Scores on a scale
Standard Deviation 1.826
|
-0.19 Scores on a scale
Standard Deviation 1.841
|
0.00 Scores on a scale
Standard Deviation 1.941
|
|
Change From Baseline in Itchy Score
Day 1
|
-0.18 Scores on a scale
Standard Deviation 1.679
|
-0.21 Scores on a scale
Standard Deviation 1.663
|
-0.32 Scores on a scale
Standard Deviation 1.588
|
-0.43 Scores on a scale
Standard Deviation 1.597
|
-0.36 Scores on a scale
Standard Deviation 1.615
|
-0.25 Scores on a scale
Standard Deviation 1.624
|
-0.29 Scores on a scale
Standard Deviation 1.630
|
-0.36 Scores on a scale
Standard Deviation 1.592
|
|
Change From Baseline in Itchy Score
Day 2
|
-0.46 Scores on a scale
Standard Deviation 1.679
|
-0.19 Scores on a scale
Standard Deviation 1.767
|
-0.31 Scores on a scale
Standard Deviation 1.692
|
-0.46 Scores on a scale
Standard Deviation 1.679
|
-0.27 Scores on a scale
Standard Deviation 1.801
|
-0.27 Scores on a scale
Standard Deviation 1.710
|
-0.27 Scores on a scale
Standard Deviation 1.756
|
-0.38 Scores on a scale
Standard Deviation 1.675
|
|
Change From Baseline in Itchy Score
Day 3
|
-0.37 Scores on a scale
Standard Deviation 1.735
|
-0.19 Scores on a scale
Standard Deviation 1.733
|
-0.22 Scores on a scale
Standard Deviation 1.717
|
-0.26 Scores on a scale
Standard Deviation 1.789
|
-0.18 Scores on a scale
Standard Deviation 2.091
|
-0.04 Scores on a scale
Standard Deviation 1.891
|
-0.14 Scores on a scale
Standard Deviation 1.840
|
-0.04 Scores on a scale
Standard Deviation 2.047
|
SECONDARY outcome
Timeframe: Day 1, 2, 3 and 4Population: The Intent-to-Treat (ITT) set include all participants who received laser-induced wounds and started the study treatments. Here 'n' (number analyzed) included all evaluable participants analyzed at specified timepoints. As planned, for this outcome measure, the data was reported for each bandage separately.
Participants were asked to rate the pain as either brief, periodic, or constant in arm resting position with the Self-Assessment Questionnaire (question 2). Number of participants with pain duration (brief, periodic, or constant) with arm resting by side was reported.
Outcome measures
| Measure |
Negative Control
n=36 Participants
Minor wounds were created on participant's forearms (four per arm) by a certified laser specialist. On the randomized wound site, no treatment was applied as the wound remained uncovered as negative control.
|
Marketed Adhesive Bandage
n=36 Participants
Minor wounds were created on participant's forearms (four per arm) by a certified laser specialist. On the randomized wound site, marketed adhesive bandage was applied. Bandages were changed daily/every other day until the wound reached a composite healing score of 8. The bandage was not left on after a composite healing score of 8 was achieved.
|
Marketed Adhesive Bandage IP-1 Benchmark Control 1
n=36 Participants
Minor wounds were created on participant's forearms (four per arm) by a certified laser specialist. On the randomized wound site, benchmark control 1 bandage was applied. Bandages were changed daily/every other day until the wound reached a composite healing score of 8. The bandage was not left on after a composite healing score of 8 was achieved.
|
Non-marketed Adhesive Bandage IP-Benchmark Control 2
n=36 Participants
Minor wounds were created on participant's forearms (four per arm) by a certified laser specialist. On the randomized wound site, benchmark control 2 bandage was applied. Bandages were changed daily/every other day until the wound reached a composite healing score of 8. The bandage was not left on after a composite healing score of 8 was achieved.
|
Non-marketed Adhesive Bandage IP #1
n=36 Participants
Minor wounds were created on participant's forearms (four per arm) by a certified laser specialist. On the randomized wound site, non-marketed IP#1 bandage was applied. Bandages were changed daily/every other day until the wound reached a composite healing score of 8. The bandage was not left on after a composite healing score of 8 was achieved.
|
Non-marketed Adhesive Bandage IP #2
n=36 Participants
Minor wounds were created on participant's forearms (four per arm) by a certified laser specialist. On the randomized wound site, non-marketed IP#2 bandage was applied. Bandages were changed daily/every other day until the wound reached a composite healing score of 8. The bandage was not left on after a composite healing score of 8 was achieved.
|
Non-marketed Adhesive Bandage IP #3
n=36 Participants
Minor wounds were created on participant's forearms (four per arm) by a certified laser specialist. On the randomized wound site, non-marketed IP#3 bandage was applied. Bandages were changed daily/every other day until the wound reached a composite healing score of 8. The bandage was not left on after a composite healing score of 8 was achieved.
|
Non-marketed Adhesive Bandage IP #4
n=36 Participants
Minor wounds were created on participant's forearms (four per arm) by a certified laser specialist. On the randomized wound site, non-marketed IP#4 bandage was applied. Bandages were changed daily/every other day until the wound reached a composite healing score of 8. The bandage was not left on after a composite healing score of 8 was achieved.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Pain Duration With Arm Resting by Side
Day 2: Brief
|
17 Participants
|
17 Participants
|
17 Participants
|
17 Participants
|
17 Participants
|
17 Participants
|
17 Participants
|
17 Participants
|
|
Number of Participants With Pain Duration With Arm Resting by Side
Day 2: Periodic
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Pain Duration With Arm Resting by Side
Baseline: Brief
|
18 Participants
|
21 Participants
|
20 Participants
|
21 Participants
|
20 Participants
|
19 Participants
|
19 Participants
|
19 Participants
|
|
Number of Participants With Pain Duration With Arm Resting by Side
Day 1: Periodic
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Pain Duration With Arm Resting by Side
Day 4: Constant
|
18 Participants
|
18 Participants
|
18 Participants
|
18 Participants
|
18 Participants
|
18 Participants
|
18 Participants
|
17 Participants
|
|
Number of Participants With Pain Duration With Arm Resting by Side
Day 4: Brief
|
16 Participants
|
16 Participants
|
16 Participants
|
16 Participants
|
16 Participants
|
16 Participants
|
16 Participants
|
17 Participants
|
|
Number of Participants With Pain Duration With Arm Resting by Side
Day 4: Periodic
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Pain Duration With Arm Resting by Side
Baseline: Periodic
|
2 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
|
Number of Participants With Pain Duration With Arm Resting by Side
Baseline: Constant
|
11 Participants
|
10 Participants
|
8 Participants
|
8 Participants
|
10 Participants
|
10 Participants
|
10 Participants
|
9 Participants
|
|
Number of Participants With Pain Duration With Arm Resting by Side
Day 1: Brief
|
18 Participants
|
17 Participants
|
18 Participants
|
18 Participants
|
20 Participants
|
19 Participants
|
18 Participants
|
18 Participants
|
|
Number of Participants With Pain Duration With Arm Resting by Side
Day 1: Constant
|
18 Participants
|
18 Participants
|
17 Participants
|
17 Participants
|
16 Participants
|
17 Participants
|
18 Participants
|
18 Participants
|
|
Number of Participants With Pain Duration With Arm Resting by Side
Day 2: Constant
|
18 Participants
|
18 Participants
|
18 Participants
|
18 Participants
|
18 Participants
|
17 Participants
|
18 Participants
|
18 Participants
|
|
Number of Participants With Pain Duration With Arm Resting by Side
Day 3: Brief
|
16 Participants
|
16 Participants
|
16 Participants
|
16 Participants
|
16 Participants
|
15 Participants
|
16 Participants
|
15 Participants
|
|
Number of Participants With Pain Duration With Arm Resting by Side
Day 3: Periodic
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Pain Duration With Arm Resting by Side
Day 3: Constant
|
19 Participants
|
19 Participants
|
19 Participants
|
19 Participants
|
19 Participants
|
19 Participants
|
19 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: Day 1, 2, 3 and 4Population: The Intent-to-Treat (ITT) set include all participants who received laser-induced wounds and started the study treatments. Here 'n' (number analyzed) included all evaluable participants analyzed at specified timepoints. As planned, for this outcome measure, the data was reported for each bandage separately.
Participants were asked to rate the pain as either brief, periodic, or constant in arm normal motion with the Self-Assessment Questionnaire (question 4). Number of participants with pain duration (brief, periodic, or constant) with arm in normal motion was reported.
Outcome measures
| Measure |
Negative Control
n=36 Participants
Minor wounds were created on participant's forearms (four per arm) by a certified laser specialist. On the randomized wound site, no treatment was applied as the wound remained uncovered as negative control.
|
Marketed Adhesive Bandage
n=36 Participants
Minor wounds were created on participant's forearms (four per arm) by a certified laser specialist. On the randomized wound site, marketed adhesive bandage was applied. Bandages were changed daily/every other day until the wound reached a composite healing score of 8. The bandage was not left on after a composite healing score of 8 was achieved.
|
Marketed Adhesive Bandage IP-1 Benchmark Control 1
n=36 Participants
Minor wounds were created on participant's forearms (four per arm) by a certified laser specialist. On the randomized wound site, benchmark control 1 bandage was applied. Bandages were changed daily/every other day until the wound reached a composite healing score of 8. The bandage was not left on after a composite healing score of 8 was achieved.
|
Non-marketed Adhesive Bandage IP-Benchmark Control 2
n=36 Participants
Minor wounds were created on participant's forearms (four per arm) by a certified laser specialist. On the randomized wound site, benchmark control 2 bandage was applied. Bandages were changed daily/every other day until the wound reached a composite healing score of 8. The bandage was not left on after a composite healing score of 8 was achieved.
|
Non-marketed Adhesive Bandage IP #1
n=36 Participants
Minor wounds were created on participant's forearms (four per arm) by a certified laser specialist. On the randomized wound site, non-marketed IP#1 bandage was applied. Bandages were changed daily/every other day until the wound reached a composite healing score of 8. The bandage was not left on after a composite healing score of 8 was achieved.
|
Non-marketed Adhesive Bandage IP #2
n=36 Participants
Minor wounds were created on participant's forearms (four per arm) by a certified laser specialist. On the randomized wound site, non-marketed IP#2 bandage was applied. Bandages were changed daily/every other day until the wound reached a composite healing score of 8. The bandage was not left on after a composite healing score of 8 was achieved.
|
Non-marketed Adhesive Bandage IP #3
n=36 Participants
Minor wounds were created on participant's forearms (four per arm) by a certified laser specialist. On the randomized wound site, non-marketed IP#3 bandage was applied. Bandages were changed daily/every other day until the wound reached a composite healing score of 8. The bandage was not left on after a composite healing score of 8 was achieved.
|
Non-marketed Adhesive Bandage IP #4
n=36 Participants
Minor wounds were created on participant's forearms (four per arm) by a certified laser specialist. On the randomized wound site, non-marketed IP#4 bandage was applied. Bandages were changed daily/every other day until the wound reached a composite healing score of 8. The bandage was not left on after a composite healing score of 8 was achieved.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Pain Duration With Arm in Normal Motion
Baseline: Constant
|
10 Participants
|
10 Participants
|
9 Participants
|
8 Participants
|
10 Participants
|
9 Participants
|
9 Participants
|
10 Participants
|
|
Number of Participants With Pain Duration With Arm in Normal Motion
Baseline: Brief
|
18 Participants
|
20 Participants
|
20 Participants
|
21 Participants
|
19 Participants
|
20 Participants
|
20 Participants
|
19 Participants
|
|
Number of Participants With Pain Duration With Arm in Normal Motion
Baseline: Periodic
|
3 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants With Pain Duration With Arm in Normal Motion
Day 1: Brief
|
17 Participants
|
17 Participants
|
18 Participants
|
18 Participants
|
19 Participants
|
19 Participants
|
18 Participants
|
18 Participants
|
|
Number of Participants With Pain Duration With Arm in Normal Motion
Day 1: Periodic
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Pain Duration With Arm in Normal Motion
Day 1: Constant
|
19 Participants
|
17 Participants
|
17 Participants
|
17 Participants
|
16 Participants
|
17 Participants
|
18 Participants
|
17 Participants
|
|
Number of Participants With Pain Duration With Arm in Normal Motion
Day 2: Brief
|
16 Participants
|
16 Participants
|
16 Participants
|
17 Participants
|
16 Participants
|
16 Participants
|
16 Participants
|
16 Participants
|
|
Number of Participants With Pain Duration With Arm in Normal Motion
Day 2: Periodic
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Pain Duration With Arm in Normal Motion
Day 2: Constant
|
19 Participants
|
19 Participants
|
19 Participants
|
18 Participants
|
19 Participants
|
18 Participants
|
19 Participants
|
19 Participants
|
|
Number of Participants With Pain Duration With Arm in Normal Motion
Day 3: Brief
|
16 Participants
|
15 Participants
|
16 Participants
|
16 Participants
|
16 Participants
|
15 Participants
|
16 Participants
|
15 Participants
|
|
Number of Participants With Pain Duration With Arm in Normal Motion
Day 3: Periodic
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Pain Duration With Arm in Normal Motion
Day 3: Constant
|
19 Participants
|
19 Participants
|
19 Participants
|
19 Participants
|
19 Participants
|
19 Participants
|
19 Participants
|
19 Participants
|
|
Number of Participants With Pain Duration With Arm in Normal Motion
Day 4: Brief
|
16 Participants
|
16 Participants
|
16 Participants
|
16 Participants
|
16 Participants
|
16 Participants
|
16 Participants
|
17 Participants
|
|
Number of Participants With Pain Duration With Arm in Normal Motion
Day 4: Periodic
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Pain Duration With Arm in Normal Motion
Day 4: Constant
|
18 Participants
|
18 Participants
|
18 Participants
|
18 Participants
|
18 Participants
|
18 Participants
|
18 Participants
|
17 Participants
|
Adverse Events
All Randomized Participants
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
All Randomized Participants
n=36 participants at risk
All Participants with Fitzpatrick skin types II (burns easily; tans minimum)-III (burns moderately; tans gradually) with uniform skin color on forearms, minor wounds were created on forearms (four per arm) by a certified laser specialist received all eight intervention at the same time on the wounds created on forearms. Each wound site was subjected to one of eight randomly-assigned treatments included in an adhesive bandage that were: 1) a marketed adhesive bandage, 2) a marketed adhesive bandage (IP-benchmark control 1), 3) a non-marketed adhesive bandage (IP-benchmark control 2), 4-7) four non-marketed adhesive bandages (IP#1, IP#2, IP#3, IP#4), and 8) no treatment (uncovered, negative control). Bandages were changed daily/every other day until the wound reached a composite healing score of 8. The bandages were not left on after a composite healing score of 8 was achieved.
|
|---|---|
|
Skin and subcutaneous tissue disorders
Erythema
|
77.8%
28/36 • Up to Day 28
Safety analysis population includes all participants who have IP applied at least once. As planned, adverse events were collected only on the whole participant level.
|
|
Skin and subcutaneous tissue disorders
Rash
|
30.6%
11/36 • Up to Day 28
Safety analysis population includes all participants who have IP applied at least once. As planned, adverse events were collected only on the whole participant level.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.6%
2/36 • Up to Day 28
Safety analysis population includes all participants who have IP applied at least once. As planned, adverse events were collected only on the whole participant level.
|
|
Skin and subcutaneous tissue disorders
Blister
|
2.8%
1/36 • Up to Day 28
Safety analysis population includes all participants who have IP applied at least once. As planned, adverse events were collected only on the whole participant level.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
2.8%
1/36 • Up to Day 28
Safety analysis population includes all participants who have IP applied at least once. As planned, adverse events were collected only on the whole participant level.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
58.3%
21/36 • Up to Day 28
Safety analysis population includes all participants who have IP applied at least once. As planned, adverse events were collected only on the whole participant level.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
5.6%
2/36 • Up to Day 28
Safety analysis population includes all participants who have IP applied at least once. As planned, adverse events were collected only on the whole participant level.
|
|
Injury, poisoning and procedural complications
Animal scratch
|
2.8%
1/36 • Up to Day 28
Safety analysis population includes all participants who have IP applied at least once. As planned, adverse events were collected only on the whole participant level.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
2.8%
1/36 • Up to Day 28
Safety analysis population includes all participants who have IP applied at least once. As planned, adverse events were collected only on the whole participant level.
|
|
General disorders
Oedema
|
2.8%
1/36 • Up to Day 28
Safety analysis population includes all participants who have IP applied at least once. As planned, adverse events were collected only on the whole participant level.
|
|
General disorders
Pyrexia
|
2.8%
1/36 • Up to Day 28
Safety analysis population includes all participants who have IP applied at least once. As planned, adverse events were collected only on the whole participant level.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.8%
1/36 • Up to Day 28
Safety analysis population includes all participants who have IP applied at least once. As planned, adverse events were collected only on the whole participant level.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
2.8%
1/36 • Up to Day 28
Safety analysis population includes all participants who have IP applied at least once. As planned, adverse events were collected only on the whole participant level.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested in writing, such publication will be withheld for up to an additional 60 days.
- Publication restrictions are in place
Restriction type: OTHER