Trial Outcomes & Findings for Study on Adhesion Properties of Three Different Adhesives (NCT NCT04125797)
NCT ID: NCT04125797
Last Updated: 2026-07-22
Results Overview
Did the adhesive stay attached to the skin for 72 hours (Yes/No). For the adhesive to be considered attached (yes) more than 75% adherence should be achieved. Rate of adhesion on a 5-point scale (no lift off the skin to detached and completely off the skin) 0 = ≥90% adhered (essentially no lift off the skin). 1. = ≥75% to \<90% adhered (only some edges lift off the skin). 2. = ≥50% to \<75% adhered (less than half lifts off the skin). 3. = \>0% to \< 50% adhered (more than half lifts off the skin without falling off). 4. = 0% adhered (detached and is completely off the skin). A worst-case scenario was used, i.e. the least favourable, score of the two scores (there are two scores as there are two adhesives of each type on every subject) for each type of adhesive.
COMPLETED
NA
39 participants
After a minimum of 72 hours (no more than 3 days) after application the adhesives will be removed and assessed by a medical doctor
2026-07-22
Participant Flow
This clinical investigation was a single centre, double blinded, case control study in healthy adult females. The investigation centre enrolled 39 subjects within one month. The three (3) types adhesive were randomly placed on subject's trunk. Each study participant will test two patches of each of three different experimental adhesives. Six patches in total. One set of each adhesive will be placed on the right side of the trunk while another set will be placed on the left side of the trunk.
Unit of analysis: Patches
Participant milestones
| Measure |
All Study Participants
Each study participant will test two patches of each of three different experimental adhesives. Six patches in total.
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|---|---|
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Overall Study
STARTED
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39 234
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Overall Study
Adhesive Type 1 (3M2475P)
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38 76
|
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Overall Study
Adhesive Type 2 (RX1449P)
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38 76
|
|
Overall Study
Adhesive Type 3 (PS-1243)
|
38 76
|
|
Overall Study
COMPLETED
|
38 228
|
|
Overall Study
NOT COMPLETED
|
1 6
|
Reasons for withdrawal
| Measure |
All Study Participants
Each study participant will test two patches of each of three different experimental adhesives. Six patches in total.
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|---|---|
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Overall Study
1 subject was excluded from the analysis as randomization and adhesive placement recorded was insuff
|
1
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Baseline Characteristics
Only female were included in the study
Baseline characteristics by cohort
| Measure |
All Study Participants
n=38 Participants
Each study participant will test two patches of each of three different experimental adhesives. Six patches in total. One set of each adhesive will be placed on the right side of the trunk while another set will be placed on the left side of the trunk. The position of the three adhesives on each side are randomly allocated.
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|---|---|
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Age, Customized
Age
|
24.16 Years
STANDARD_DEVIATION 2.90 • n=38 Participants
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Sex: Female, Male
Female
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38 Participants
n=38 Participants • Only female were included in the study
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Sex: Female, Male
Male
|
0 Participants
n=38 Participants • Only female were included in the study
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PRIMARY outcome
Timeframe: After a minimum of 72 hours (no more than 3 days) after application the adhesives will be removed and assessed by a medical doctorDid the adhesive stay attached to the skin for 72 hours (Yes/No). For the adhesive to be considered attached (yes) more than 75% adherence should be achieved. Rate of adhesion on a 5-point scale (no lift off the skin to detached and completely off the skin) 0 = ≥90% adhered (essentially no lift off the skin). 1. = ≥75% to \<90% adhered (only some edges lift off the skin). 2. = ≥50% to \<75% adhered (less than half lifts off the skin). 3. = \>0% to \< 50% adhered (more than half lifts off the skin without falling off). 4. = 0% adhered (detached and is completely off the skin). A worst-case scenario was used, i.e. the least favourable, score of the two scores (there are two scores as there are two adhesives of each type on every subject) for each type of adhesive.
Outcome measures
| Measure |
All Study Participants
n=38 Participants
Each study participant will test two patches of each of three different experimental adhesives. Six patches in total. One set of each adhesive will be placed on the right side of the trunk while another set will be placed on the left side of the trunk. The position of the three adhesives on each side are randomly allocated.
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|---|---|
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Number of Participants Who Achieved Adhesion Success After 72 Hours
Adhesive Type 1 (3M2475P)
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25 Participants
|
|
Number of Participants Who Achieved Adhesion Success After 72 Hours
Adhesive Type 2 (RX1449P)
|
23 Participants
|
|
Number of Participants Who Achieved Adhesion Success After 72 Hours
Adhesive Type 3 (PS-1243)
|
34 Participants
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SECONDARY outcome
Timeframe: 24, 48 and 72 hours after adhesive applicationSubject evaluation of itchiness caused by the adhesives at 24, 48, 72 hours measured on visual analogue scale (VAS) (0-10) 0 = 'No itch', 10 = Worst imaginable itch. Adhesives when only including the worst score on each adhesive for each subject
Outcome measures
| Measure |
All Study Participants
n=38 Participants
Each study participant will test two patches of each of three different experimental adhesives. Six patches in total. One set of each adhesive will be placed on the right side of the trunk while another set will be placed on the left side of the trunk. The position of the three adhesives on each side are randomly allocated.
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|---|---|
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Number of Participants Experiencing Itchiness by the Adhesive at 24, 48 and 72 Hours
Adhesive Type 2 (RX1449P)- 72 hours
|
2 Participants
|
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Number of Participants Experiencing Itchiness by the Adhesive at 24, 48 and 72 Hours
Adhesive Type 2 (RX1449P)- 24 hours
|
1 Participants
|
|
Number of Participants Experiencing Itchiness by the Adhesive at 24, 48 and 72 Hours
Adhesive Type 3 (PS-1243)- 24 hours
|
2 Participants
|
|
Number of Participants Experiencing Itchiness by the Adhesive at 24, 48 and 72 Hours
Adhesive Type 1 (3M2475P) - 72 hours
|
2 Participants
|
|
Number of Participants Experiencing Itchiness by the Adhesive at 24, 48 and 72 Hours
Adhesive Type 1 (3M2475P) - 24 hours
|
4 Participants
|
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Number of Participants Experiencing Itchiness by the Adhesive at 24, 48 and 72 Hours
Adhesive Type 1 (3M2475P) - 48 hours
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3 Participants
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Number of Participants Experiencing Itchiness by the Adhesive at 24, 48 and 72 Hours
Adhesive Type 2 (RX1449P)- 48hours
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3 Participants
|
|
Number of Participants Experiencing Itchiness by the Adhesive at 24, 48 and 72 Hours
Adhesive Type 3 (PS-1243)- 48 hours
|
3 Participants
|
|
Number of Participants Experiencing Itchiness by the Adhesive at 24, 48 and 72 Hours
Adhesive Type 3 (PS-1243)- 72 hours
|
1 Participants
|
SECONDARY outcome
Timeframe: After a minimum of 72 hours (no more than 3 days) after application the adhesives will be removed and assessed by a medical doctorEase of removal on 5-point scale (very difficult to very easy) ; 1: Very difficult; 2: Difficult; 3: Acceptable; 4: Easy; 5: Very easy.
Outcome measures
| Measure |
All Study Participants
n=38 Participants
Each study participant will test two patches of each of three different experimental adhesives. Six patches in total. One set of each adhesive will be placed on the right side of the trunk while another set will be placed on the left side of the trunk. The position of the three adhesives on each side are randomly allocated.
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|---|---|
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Rate of Ease of Removal of Adhesive After 72 Hours
Adhesive Type 1 (3M2475P)
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3.58 Score on a scale
Standard Deviation 0.69
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Rate of Ease of Removal of Adhesive After 72 Hours
Adhesive Type 2 (RX1449P)
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4.21 Score on a scale
Standard Deviation 0.69
|
|
Rate of Ease of Removal of Adhesive After 72 Hours
Adhesive Type 3 (PS-1243)
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3.43 Score on a scale
Standard Deviation 0.83
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SECONDARY outcome
Timeframe: After a minimum of 72 hours (no more than 3 days) after application the adhesives will be removed and assessed by a medical doctorSubject evaluation of pain during removal of the adhesives measured on visual analogue scale (0-10). 0= no pain, 10 = Worst possible pain
Outcome measures
| Measure |
All Study Participants
n=38 Participants
Each study participant will test two patches of each of three different experimental adhesives. Six patches in total. One set of each adhesive will be placed on the right side of the trunk while another set will be placed on the left side of the trunk. The position of the three adhesives on each side are randomly allocated.
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|---|---|
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Rate of Pain During Removal of Adhesive After 72 Hours
Adhesive Type 1 (3M2475P)
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0.42 Score on a scale
Standard Deviation 0.60
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Rate of Pain During Removal of Adhesive After 72 Hours
Adhesive Type 2 (RX1449P)
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0.35 Score on a scale
Standard Deviation 0.60
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|
Rate of Pain During Removal of Adhesive After 72 Hours
Adhesive Type 3 (PS-1243)
|
0.32 Score on a scale
Standard Deviation 0.58
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SECONDARY outcome
Timeframe: After a minimum of 72 hours (no more than 3 days) after application the adhesives will be removed and assessed by a medical doctorSkin reaction rated on a scale from 0-7 (no evidence of irritation to strong reaction spreading beyond the application site). 0: No evidence of irritation 1. Minimal erythema that is barely perceptible 2. Definite erythema that is readily visible and minimal edema or minimal papular response 3. Erythema and papules 4. Definite edema 5. Erythema, edema and papules 6. Vesicular eruption 7. Strong reaction spreading beyond the application site
Outcome measures
| Measure |
All Study Participants
n=38 Participants
Each study participant will test two patches of each of three different experimental adhesives. Six patches in total. One set of each adhesive will be placed on the right side of the trunk while another set will be placed on the left side of the trunk. The position of the three adhesives on each side are randomly allocated.
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|---|---|
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Rate of Skin Reaction After Wearing Adhesive for 72 Hours
Adhesive Type 1 (3M2475P)
|
0.25 Score on a scale
Standard Deviation 0.50
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|
Rate of Skin Reaction After Wearing Adhesive for 72 Hours
Adhesive Type 2 (RX1449P)
|
0.26 Score on a scale
Standard Deviation 0.51
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|
Rate of Skin Reaction After Wearing Adhesive for 72 Hours
Adhesive Type 3 (PS-1243)
|
0.38 Score on a scale
Standard Deviation 0.55
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SECONDARY outcome
Timeframe: After a minimum of 72 hours (no more than 3 days) after application the adhesives will be removed and assessed by a medical doctorThe number of participants with any adhesive residue left on skin after removal of adhesive (yes/no) after 72 hours.
Outcome measures
| Measure |
All Study Participants
n=38 Participants
Each study participant will test two patches of each of three different experimental adhesives. Six patches in total. One set of each adhesive will be placed on the right side of the trunk while another set will be placed on the left side of the trunk. The position of the three adhesives on each side are randomly allocated.
|
|---|---|
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Number of Participants With Adhesive Residue Left on Skin After Removal of Adhesive
Adhesive Type 2 (RX1449P)
|
2 Participants
|
|
Number of Participants With Adhesive Residue Left on Skin After Removal of Adhesive
Adhesive Type 3 (PS-1243)
|
5 Participants
|
|
Number of Participants With Adhesive Residue Left on Skin After Removal of Adhesive
Adhesive Type 1 (3M2475P)
|
2 Participants
|
Adverse Events
All Study Participants
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
All Study Participants
n=38 participants at risk
Each study participant will test two patches of each of three different experimental adhesives. Six patches in total. One set of each adhesive will be placed on the right side of the trunk while another set will be placed on the left side of the trunk. The position of the three adhesives on each side are randomly allocated.
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|---|---|
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Skin and subcutaneous tissue disorders
Erythema and mild edema
|
2.6%
1/38 • Up to 72 hours
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place