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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

36 participants

Primary outcome timeframe

Up to Day 16

Results posted on

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

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.
Overall Study
STARTED
36
Overall Study
Treated
36
Overall Study
COMPLETED
33
Overall Study
NOT COMPLETED
3

Reasons for withdrawal

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.
Overall Study
Protocol Violation
1
Overall Study
Withdrawal by Subject
2

Baseline Characteristics

A Study to Assess Wound Healing Efficacies of Different Adhesive Bandages

Baseline characteristics by cohort

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.
Age, Continuous
43.0 Years
STANDARD_DEVIATION 8.01 • n=99 Participants
Sex: Female, Male
Female
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
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
12 Participants
n=99 Participants

PRIMARY outcome

Timeframe: Up to Day 16

Population: 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

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.
Time to Complete Wound Healing
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

SECONDARY outcome

Timeframe: Day 0 (immediate after wound creation), Day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14

Population: 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

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 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
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
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
25.31 gram (g)/meter(m)^2/hour (g/m^2/hr)
Standard Deviation 12.042
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
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 16

Population: 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

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 16

Population: 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

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 28

Population: 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

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 4

Population: 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

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 4

Population: 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

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 4

Population: 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

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 4

Population: 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

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 4

Population: 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

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 events: 0 serious events
Other events: 34 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

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

Robin Mathew

Johnson & Johnson Consumer Inc. (J&JCI)

Phone: 908-904-5034

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