A Study to Assess Wound Healing Efficacies of Different Adhesive Bandages

• Sponsor: Johnson & Johnson Consumer Inc. (J&JCI) (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04040933
• Collaborator: (none)
• Enrollment: 36
• Location: 1
• Arms: 8
• Actual Duration (Months): 2.7
• Patients Per Site Per Month: 13.4

Study Details

Study Description

Brief Summary

The purpose of this study is to assess the wound healing efficacy (time to complete healing) of different adhesive bandages.

Condition or Disease	Intervention/Treatment	Phase
Wound Healing	Device: Marketed Adhesive Bandage #1; Device: Marketed Bandage #2; Device: Non-Marketed Bandage #1; Device: Non-Marketed Bandage #2; Device: Non-Marketed Adhesive Bandage #3; Device: Non-Marketed Adhesive Bandage #4; Device: Non-Marketed Adhesive Bandage #5	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 36 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Treatment
• Official Title: A 28-Day, Single-Center, Randomized, Comparator-Controlled, Proof-of-Principle Study to Assess Wound Healing Efficacies of Different Adhesive Bandages
• Actual Study Start Date: Aug 9, 2019
• Actual Primary Completion Date: Oct 18, 2019
• Actual Study Completion Date: Oct 30, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Marketed Adhesive Bandage #1 Minor wounds will be created on participant's forearms (four per arm) by a certified laser specialist. On the randomized wound site, bandage will be applied. This adhesive bandage will be changed daily from Day 1 through Day 16 and all wound sites will be uncovered from Day 16 to Day 28 for assessments.	Device: Marketed Adhesive Bandage #1; On the randomized wound site, a marketed adhesive bandage will be applied.
Active Comparator: Marketed Adhesive Bandage #2 Minor wounds will be created on participant's forearms (four per arm) by a certified laser specialist. On the randomized wound site, bandage will be applied. This adhesive bandage will be changed only on Days 3, 5, 7, 9, 11, 13, 15, and 16 and all wound sites will be uncovered from Day 16 to Day 28 for assessments.	Device: Marketed Bandage #2; On the randomized wound site, a marketed adhesive bandage will be applied.
Active Comparator: Non-marketed Adhesive Bandage #1 Minor wounds will be created on participant's forearms (four per arm) by a certified laser specialist. On the randomized wound site, bandage will be applied. This adhesive bandage will be changed daily from Day 1 through Day 16 and all wound sites will be uncovered from Day 16 to Day 28 for assessments.	Device: Non-Marketed Bandage #1; On the randomized wound site, a non-marketed adhesive bandage will be applied.
Experimental: Non-marketed Adhesive Bandage #2 Minor wounds will be created on participant's forearms (four per arm) by a certified laser specialist. On the randomized wound site, bandage will be applied. This adhesive bandage will be changed daily from Day 1 through Day 16 and all wound sites will be uncovered from Day 16 to Day 28 for assessments.	Device: Non-Marketed Bandage #2; On the randomized wound site, a non-marketed adhesive bandage will be applied.
Experimental: Non-marketed Adhesive Bandage #3 Minor wounds will be created on participant's forearms (four per arm) by a certified laser specialist. On the randomized wound site, bandage will be applied. This adhesive bandage will be changed daily from Day 1 through Day 16 and all wound sites will be uncovered from Day 16 to Day 28 for assessments.	Device: Non-Marketed Adhesive Bandage #3; On the randomized wound site, a non-marketed adhesive bandage will be applied.
Experimental: Non-marketed Adhesive Bandage #4 Minor wounds will be created on participant's forearms (four per arm) by a certified laser specialist. On the randomized wound site, bandage will be applied. This adhesive bandage will be changed daily from Day 1 through Day 16 and all wound sites will be uncovered from Day 16 to Day 28 for assessments.	Device: Non-Marketed Adhesive Bandage #4; On the randomized wound site, a non-marketed adhesive bandage will be applied.
Experimental: Non-marketed Adhesive Bandage #5 Minor wounds will be created on participant's forearms (four per arm) by a certified laser specialist. On the randomized wound site, bandage will be applied. This adhesive bandage will be changed daily from Day 1 through Day 16 and all wound sites will be uncovered from Day 16 to Day 28 for assessments.	Device: Non-Marketed Adhesive Bandage #5; On the randomized wound site, a non-marketed adhesive bandage will be applied.
No Intervention: No Treatment (Uncovered, Negative Control) Minor wounds will be created on participant's forearms (four per arm) by a certified laser specialist. On the randomized wound site, no treatment will be applied as the wound will be kept uncovered as negative control.

Outcome Measures

Primary Outcome Measures

1. Time to Complete Wound Healing [Up to Day 16]

   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.

Secondary Outcome Measures

1. Change From Baseline in Trans-Epidermal Water Loss (TEWL) Measurements [Day 0 (immediate after wound creation), Day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14]

   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.

2. Change From Baseline in Clinical Grading of Wound Healing Parameter - Erythema [Day 0 (immediate after wound creation), Day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15 and 16]

   Change from baseline in Clinical grading of wound healing parameter (erythema) was evaluated on a scale of 0 (no erythema) to 4 (severe erythema).

3. Change From Baseline in Clinical Grading of Wound Healing Parameter - Edema [Day 0 (immediate after wound creation), Day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15 and 16]

   Change from baseline in Clinical grading of wound healing parameter (edema) was evaluated on a scale of 0 (no edema) to 4 (severe edema).

4. Change From Baseline in Composite Scar Score [Baseline and Day 28]

   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.

5. Change From Baseline in Painful Score With Arm Resting by Side [Baseline, Day 1, 2, 3 and 4]

   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).

6. Change From Baseline in Painful Score With Arm in Normal Motion [Baseline, Day 1, 2, 3 and 4]

   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).

7. Change From Baseline in Itchy Score [Baseline, Day 1, 2, 3 and 4]

   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).

8. Number of Participants With Pain Duration With Arm Resting by Side [Day 1, 2, 3 and 4]

   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.

9. Number of Participants With Pain Duration With Arm in Normal Motion [Day 1, 2, 3 and 4]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 25 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Fitzpatrick Skin Type II or III

• Uniform skin color on both volar forearms

• Generally in good health based on medical history reported by the participant

• -Individual has signed the Photographic Release and Informed Consent Documents along with (HIPAA) disclosure

• Willing to have temporary (semi-permanent) dot-tattoos applied to the volar forearms

Exclusion Criteria:

• Has known allergies, hypersensitivity, or adverse reactions to anesthetics, adhesive bandages, latex, wound treatment products, or any component/ingredient present in the Investigational Products (IPs)/auxiliary/ancillary products

• Has a known history of a blood-clotting disorder, keloid formation, or a cardiovascular, hepatic, or renal disease

• Presents with a skin condition that would, in the opinion of the PI or Study Physician, confound study results, increase risk to participant, or interfere with study evaluations

• Has excessive hair or tattoos on either volar forearm

• Has a known history of severe systemic immune system disorders

• Has self-reported Type 1 or Type 2 diabetes

• Has self-reported uncontrolled chronic diseases

• Is taking medication that would mask an adverse event, confound study results or alter/compromise the bleeding/healing process

• Is self-reported to be pregnant or planning to become pregnant

• Has a body mass index (BMI) above 35

• Is self-reported to be an alcohol or drug abuser

• Has participated in another clinical trial within 10 days

• Either is or lives with someone who is a current employee of any company that makes/markets adhesive bandages or first-aid products

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Thomas J. Stephens	Richardson	Texas	United States	75081

Sponsors and Collaborators

• Johnson & Johnson Consumer Inc. (J&JCI)

Investigators

• Principal Investigator: Lily Jiang, PhD, Thomas J. Stephens & Associates, Inc.

Study Documents (Full-Text)

• Study Protocol - Aug 28, 2019
• Statistical Analysis Plan - Oct 21, 2019

More Information

Publications

None provided.

• Responsible Party: Johnson & Johnson Consumer Inc. (J&JCI)
• ClinicalTrials.gov Identifier: NCT04040933
• Other Study ID Numbers: CCSTOH001689; CCSTOH001689
• First Posted: Aug 1, 2019
• Last Update Posted: Jul 13, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Wounds and Injuries

Study Results

Participant Flow

Pre-assignment Detail

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.

Arm/Group Title	All Randomized Participants
Arm/Group Description	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.
Period Title: Overall Study
STARTED	36
Treated	36
COMPLETED	33
NOT COMPLETED	3

Baseline Characteristics

Arm/Group Title	All Randomized Participants
Arm/Group Description	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 Participants	36
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	43.0 (8.01)
Sex: Female, Male (Count of Participants)
Female	30 83.3%
Male	6 16.7%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	8 22.2%
Not Hispanic or Latino	28 77.8%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	3 8.3%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	0 0%
White	33 91.7%
More than one race	0 0%
Unknown or Not Reported	0 0%
Fitzpatrick Skin Classification (Count of Participants)
Fitzpatrick Skin Classification - II	24 66.7%
Fitzpatrick Skin Classification - III	12 33.3%

Outcome Measures

1. Secondary Outcome

Title	Change From Baseline in Trans-Epidermal Water Loss (TEWL) Measurements
Description	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.
Time Frame	Day 0 (immediate after wound creation), Day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Negative Control	Marketed Adhesive Bandage	Marketed Adhesive Bandage IP-1 Benchmark Control 1	Non-marketed Adhesive Bandage IP-Benchmark Control 2	Non-marketed Adhesive Bandage IP #1	Non-marketed Adhesive Bandage IP #2	Non-marketed Adhesive Bandage IP #3	Non-marketed Adhesive Bandage IP #4
Arm/Group Description	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.	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.	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.	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.	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.	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.	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.	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.
Measure Participants	36	36	36	36	36	36	36	36
Day 0	39.27 (8.240)	37.99 (10.050)	39.57 (8.796)	40.71 (9.284)	39.06 (11.257)	36.47 (8.789)	38.74 (7.455)
Day 1	39.70 (9.681)	37.86 (11.667)	36.30 (10.345)	31.48 (11.157)	34.96 (10.541)	30.48 (8.864)	40.14 (13.278)
Day 2	25.31 (12.042)	16.74 (11.902)	14.08 (14.260)	7.47 (6.792)	11.68 (7.032)	9.59 (6.051)	19.55 (11.594)
Day 3	12.80 (13.071)	7.24 (9.361)	2.33 (7.219)	5.67 (11.081)	4.60 (7.837)	7.01 (5.896)	5.37 (7.189)	7.05 (8.513)
Day 4	5.81 (10.096)	2.65 (7.517)	1.14 (9.210)	5.09 (7.174)	5.55 (11.303)	3.71 (6.299)	1.37 (7.505)
Day 5	1.62 (7.636)	-0.21 (6.273)	-0.64 (6.867)	-1.47 (5.626)	7.33 (8.932)	4.56 (5.270)	1.88 (5.856)	-2.42 (4.974)
Day 6	5.40 (7.519)	3.02 (7.410)	3.73 (7.495)	9.36 (7.163)	6.56 (5.736)	6.35 (5.221)	1.04 (6.633)
Day 7	1.89 (7.505)	0.42 (6.266)	4.33 (6.751)	2.95 (14.523)	9.45 (8.722)	4.70 (5.079)	3.51 (7.782)	-0.78 (6.177)
Day 8	2.29 (6.629)	2.22 (8.670)	2.66 (7.315)	9.24 (8.642)	5.81 (5.742)	5.16 (6.224)	1.61 (8.170)
Day 9	2.67 (8.623)	3.60 (6.604)	7.75 (7.210)	3.15 (9.808)	7.44 (6.151)	6.50 (5.898)	4.49 (6.350)	1.60 (7.721)
Day 10	0.61 (6.125)	1.84 (7.714)	0.81 (6.908)	5.50 (6.187)	3.79 (5.137)	3.78 (6.538)	-0.48 (6.885)
Day 11	1.30 (5.810)	2.76 (7.082)	4.20 (7.264)	1.78 (7.190)	5.60 (7.211)	5.11 (4.491)	6.89 (8.666)	3.40 (13.542)
Day 12	0.60 (7.181)	0.47 (6.433)	0.52 (5.468)	1.21 (4.225)	3.99 (6.655)	3.66 (7.701)	0.79 (8.074)
Day 13	1.69 (6.367)	1.96 (6.642)	3.97 (7.060)	0.59 (5.786)	4.05 (5.576)	5.68 (11.911)	2.61 (6.831)	1.13 (6.594)
Day 14	0.91 (6.472)	0.32 (5.469)	0.55 (6.035)	3.17 (4.744)	4.33 (4.902)	4.81 (12.362)	1.97 (9.991)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Negative Control, Non-marketed Adhesive Bandage IP #1
	Comments
	Type of Statistical Test	Other
	Comments	Change from Baseline in TEWL measurements was analyzed within-treatment and between-treatment. The within-treatment comparison was performed at each baseline score within each treatment using paired t-test. The between-treatment comparison was performed by comparing the change from baseline between treatments using a mixed effect analysis of covariance (ANCOVA) model.
Statistical Test of Hypothesis	p-Value	0.860
	Comments
	Method	ANCOVA
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Marketed Adhesive Bandage, Non-marketed Adhesive Bandage IP #1
	Comments
	Type of Statistical Test	Other
	Comments	Change from Baseline in TEWL measurements was analyzed within-treatment and between-treatment. The within-treatment comparison was performed at each baseline score within each treatment using paired t-test. The between-treatment comparison was performed by comparing the change from baseline between treatments using a mixed effect analysis of covariance (ANCOVA) model.
Statistical Test of Hypothesis	p-Value	0.051
	Comments
	Method	ANCOVA
	Comments

2. Secondary Outcome

Title	Change From Baseline in Clinical Grading of Wound Healing Parameter - Erythema
Description	Change from baseline in Clinical grading of wound healing parameter (erythema) was evaluated on a scale of 0 (no erythema) to 4 (severe erythema).
Time Frame	Day 0 (immediate after wound creation), Day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15 and 16

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Negative Control	Marketed Adhesive Bandage	Marketed Adhesive Bandage IP-1 Benchmark Control 1	Non-marketed Adhesive Bandage IP-Benchmark Control 2	Non-marketed Adhesive Bandage IP #1	Non-marketed Adhesive Bandage IP #2	Non-marketed Adhesive Bandage IP #3	Non-marketed Adhesive Bandage IP #4
Arm/Group Description	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.	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.	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.	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.	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.	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.	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.	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.
Measure Participants	36	36	36	36	36	36	36	36
Day 0	1.04 (0.469)	1.06 (0.459)	1.08 (0.486)	1.08 (0.486)	1.07 (0.509)	1.07 (0.550)	1.06 (0.459)
Day 1	3.03 (0.686)	2.28 (0.760)	2.07 (0.645)	2.13 (0.740)	2.10 (0.791)	2.42 (0.849)	2.03 (0.632)
Day 2	3.51 (0.624)	2.14 (0.703)	1.83 (0.747)	1.60 (0.746)	1.79 (0.730)	2.30 (0.769)	1.81 (0.665)
Day 3	3.50 (0.630)	2.00 (0.795)	1.62 (0.650)	1.67 (0.696)	1.29 (0.740)	1.63 (0.668)	2.40 (0.705)	1.74 (0.657)
Day 4	3.44 (0.600)	1.82 (0.797)	1.50 (0.728)	1.03 (0.651)	1.49 (0.702)	2.25 (0.751)	1.69 (0.718)
Day 5	3.09 (0.691)	1.72 (0.698)	1.21 (0.687)	1.51 (0.668)	0.69 (0.508)	1.53 (0.651)	2.09 (0.633)	1.76 (0.710)
Day 6	2.82 (0.727)	1.66 (0.648)	1.31 (0.640)	0.54 (0.528)	1.28 (0.630)	2.04 (0.829)	1.62 (0.729)
Day 7	2.41 (0.883)	1.65 (0.764)	0.79 (0.676)	1.41 (0.645)	0.56 (0.519)	1.31 (0.779)	1.94 (0.736)	1.75 (0.846)
Day 8	2.33 (0.747)	1.45 (0.754)	1.24 (0.675)	0.62 (0.587)	1.17 (0.633)	1.68 (0.694)	1.89 (0.726)
Day 9	1.98 (0.805)	1.38 (0.696)	0.79 (0.685)	0.98 (0.523)	0.42 (0.378)	0.95 (0.474)	1.44 (0.560)	1.67 (0.736)
Day 10	1.88 (0.839)	1.14 (0.628)	0.88 (0.500)	0.44 (0.390)	0.86 (0.462)	1.15 (0.569)	1.52 (0.798)
Day 11	1.67 (0.845)	1.02 (0.492)	0.56 (0.390)	0.86 (0.472)	0.39 (0.370)	0.80 (0.455)	1.13 (0.511)	1.41 (0.798)
Day 12	1.38 (0.650)	0.88 (0.662)	0.68 (0.411)	0.32 (0.302)	0.67 (0.433)	0.91 (0.538)	1.25 (0.660)
Day 13	1.20 (0.624)	0.70 (0.450)	0.41 (0.384)	0.61 (0.410)	0.26 (0.309)	0.58 (0.404)	0.94 (0.543)	1.16 (0.665)
Day 14	1.23 (0.574)	0.65 (0.537)	0.53 (0.394)	0.27 (0.333)	0.42 (0.383)	0.95 (0.567)	1.05 (0.601)
Day 15	1.09 (0.537)	0.58 (0.417)	0.30 (0.329)	0.48 (0.385)	0.17 (0.239)	0.38 (0.311)	0.72 (0.446)	0.92 (0.555)
Day 16	1.08 (0.486)	0.56 (0.480)	0.38 (0.331)	0.47 (0.374)	0.17 (0.239)	0.36 (0.364)	0.79 (0.535)	0.86 (0.650)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Negative Control, Non-marketed Adhesive Bandage IP #1
	Comments
	Type of Statistical Test	Other
	Comments	Change from Baseline in Erythema measurements was analyzed within-treatment and between-treatment. The within-treatment comparison was performed at each post-baseline time point by comparing the post-baseline scores with the baseline score within each treatment using the paired t-test. The between-treatment comparison was performed by comparing the change from baseline between treatments using a mixed effect analysis of covariance (ANCOVA) model.
Statistical Test of Hypothesis	p-Value	0.259
	Comments
	Method	ANCOVA
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Marketed Adhesive Bandage, Non-marketed Adhesive Bandage IP #1
	Comments
	Type of Statistical Test	Other
	Comments	Change from Baseline in Erythema measurements was analyzed within-treatment and between-treatment. The within-treatment comparison was performed at each post-baseline time point by comparing the post-baseline scores with the baseline score within each treatment using the paired t-test. The between-treatment comparison was performed by comparing the change from baseline between treatments using a mixed effect analysis of covariance (ANCOVA) model.
Statistical Test of Hypothesis	p-Value	0.451
	Comments
	Method	ANCOVA
	Comments

3. Secondary Outcome

Title	Change From Baseline in Clinical Grading of Wound Healing Parameter - Edema
Description	Change from baseline in Clinical grading of wound healing parameter (edema) was evaluated on a scale of 0 (no edema) to 4 (severe edema).
Time Frame	Day 0 (immediate after wound creation), Day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15 and 16

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Negative Control	Marketed Adhesive Bandage	Marketed Adhesive Bandage IP-1 Benchmark Control 1	Non-marketed Adhesive Bandage IP-Benchmark Control 2	Non-marketed Adhesive Bandage IP #1	Non-marketed Adhesive Bandage IP #2	Non-marketed Adhesive Bandage IP #3	Non-marketed Adhesive Bandage IP #4
Arm/Group Description	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.	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.	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.	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.	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.	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.	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.	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.
Measure Participants	36	36	36	36	36	36	36	36
Day 0	0.22 (0.326)	0.21 (0.325)	0.22 (0.347)	0.22 (0.326)	0.26 (0.439)	0.28 (0.454)	0.22 (0.347)
Day 1	0.42 (0.439)	0.01 (0.083)	0.00 (0.000)	0.00 (0.000)	0.00 (0.000)	0.00 (0.000)	0.00 (0.000)
Day 2	0.16 (0.291)	0.00 (0.000)	0.01 (0.085)	0.00 (0.000)	0.00 (0.000)	0.00 (0.000)	0.01 (0.085)
Day 3	0.09 (0.191)	0.00 (0.000)	0.00 (0.000)	0.00 (0.000)	0.00 (0.000)	0.00 (0.000)	0.00 (0.000)	0.01 (0.085)
Day 4	0.00 (0.000)	0.00 (0.000)	0.00 (0.000)	0.00 (0.000)	0.00 (0.000)	0.00 (0.000)	0.00 (0.000)
Day 5	0.00 (0.000)	0.00 (0.000)	0.03 (0.171)	0.00 (0.000)	0.00 (0.000)	0.00 (0.000)	0.00 (0.000)	0.00 (0.000)
Day 6	0.00 (0.000)	0.00 (0.000)	0.00 (0.000)	0.00 (0.000)	0.04 (0.257)	0.00 (0.000)	0.00 (0.000)
Day 7	0.00 (0.000)	0.00 (0.000)	0.00 (0.000)	0.03 (0.171)	0.00 (0.000)	0.01 (0.086)	0.00 (0.000)	0.00 (0.000)
Day 8	0.00 (0.000)	0.00 (0.000)	0.02 (0.087)	0.00 (0.000)	0.00 (0.000)	0.00 (0.000)	0.00 (0.000)
Day 9	0.00 (0.000)	0.00 (0.000)	0.00 (0.000)	0.02 (0.087)	0.00 (0.000)	0.03 (0.174)	0.00 (0.000)	0.00 (0.000)
Day 10	0.00 (0.000)	0.00 (0.000)	0.00 (0.000)	0.00 (0.000)	0.00 (0.000)	0.00 (0.000)	0.00 (0.000)
Day 11	0.00 (0.000)	0.00 (0.000)	0.00 (0.000)	0.00 (0.000)	0.00 (0.000)	0.00 (0.000)	0.00 (0.000)	0.00 (0.000)
Day 12	0.00 (0.000)	0.00 (0.000)	0.00 (0.000)	0.00 (0.000)	0.00 (0.000)	0.02 (0.096)	0.00 (0.000)
Day 13	0.00 (0.000)	0.00 (0.000)	0.00 (0.000)	0.00 (0.000)	0.00 (0.000)	0.00 (0.000)	0.04 (0.192)	0.00 (0.000)
Day 14	0.00 (0.000)	0.02 (0.087)	0.00 (0.000)	0.00 (0.000)	0.00 (0.000)	0.04 (0.189)	0.00 (0.000)
Day 15	0.00 (0.000)	0.00 (0.000)	0.00 (0.000)	0.00 (0.000)	0.00 (0.000)	0.00 (0.000)	0.00 (0.000)	0.00 (0.000)
Day 16	0.00 (0.000)	0.00 (0.000)	0.00 (0.000)	0.00 (0.000)	0.00 (0.000)	0.00 (0.000)	0.02 (0.094)	0.00 (0.000)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Negative Control, Non-marketed Adhesive Bandage IP #1
	Comments
	Type of Statistical Test	Other
	Comments	Change from Baseline in Edema measurements was analyzed within-treatment and between-treatment. The within-treatment comparison was performed at each post-baseline time point by comparing the post-baseline scores with the baseline score within each treatment using the paired t-test. The between-treatment comparison was performed by comparing the change from baseline between treatments using a mixed effect analysis of covariance (ANCOVA) model.
Statistical Test of Hypothesis	p-Value	>0.999
	Comments
	Method	ANCOVA
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Marketed Adhesive Bandage, Non-marketed Adhesive Bandage IP #1
	Comments
	Type of Statistical Test	Other
	Comments	Change from Baseline in Edema measurements was analyzed within-treatment and between-treatment. The within-treatment comparison was performed at each post-baseline time point by comparing the post-baseline scores with the baseline score within each treatment using the paired t-test. The between-treatment comparison was performed by comparing the change from baseline between treatments using a mixed effect analysis of covariance (ANCOVA) model.
Statistical Test of Hypothesis	p-Value	0.739
	Comments
	Method	ANCOVA
	Comments

4. Secondary Outcome

Title	Change From Baseline in Composite Scar Score
Description	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.
Time Frame	Baseline and Day 28

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Negative Control	Marketed Adhesive Bandage	Marketed Adhesive Bandage IP-1 Benchmark Control 1	Non-marketed Adhesive Bandage IP-Benchmark Control 2	Non-marketed Adhesive Bandage IP #1	Non-marketed Adhesive Bandage IP #2	Non-marketed Adhesive Bandage IP #3	Non-marketed Adhesive Bandage IP #4
Arm/Group Description	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.	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.	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.	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.	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.	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.	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.	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.
Measure Participants	33	33	33	33	33	33	33	33
Mean (Standard Deviation) [Scores on a scale]	2.09 (1.548)	0.61 (0.496)	0.33 (0.645)	0.42 (0.502)	0.24 (0.435)	0.30 (0.467)	0.88 (0.893)	1.18 (1.103)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Negative Control, Non-marketed Adhesive Bandage IP #1
	Comments
	Type of Statistical Test	Other
	Comments	Change from Baseline in Composite Scar Score Measurements was analyzed within-treatment and between-treatment. The within-treatment comparison was performed at each post-baseline time point by comparing the post-baseline scores with the baseline score within each treatment using the paired t-test. The between-treatment comparison was performed by comparing the change from baseline between treatments using a mixed effect analysis of covariance (ANCOVA) model.
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	ANCOVA
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Marketed Adhesive Bandage, Non-marketed Adhesive Bandage IP #1
	Comments
	Type of Statistical Test	Other
	Comments	Change from Baseline in Composite Scar Score Measurements was analyzed within-treatment and between-treatment. The within-treatment comparison was performed at each post-baseline time point by comparing the post-baseline scores with the baseline score within each treatment using the paired t-test. The between-treatment comparison was performed by comparing the change from baseline between treatments using a mixed effect analysis of covariance (ANCOVA) model.
Statistical Test of Hypothesis	p-Value	0.053
	Comments
	Method	ANCOVA
	Comments

5. Secondary Outcome

Title	Change From Baseline in Painful Score With Arm Resting by Side
Description	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).
Time Frame	Baseline, Day 1, 2, 3 and 4

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Negative Control	Marketed Adhesive Bandage	Marketed Adhesive Bandage IP-1 Benchmark Control 1	Non-marketed Adhesive Bandage IP-Benchmark Control 2	Non-marketed Adhesive Bandage IP #1	Non-marketed Adhesive Bandage IP #2	Non-marketed Adhesive Bandage IP #3	Non-marketed Adhesive Bandage IP #4
Arm/Group Description	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.	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.	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.	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.	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.	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.	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.	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.
Measure Participants	36	36	36	36	36	36	36	36
Day 1	-0.61 (1.286)	-0.32 (0.983)	-0.46 (0.999)	-0.46 (0.922)	-0.43 (1.034)	-0.54 (1.071)	-0.39 (1.031)	-0.68 (1.219)
Day 2	-0.85 (1.317)	-0.42 (1.027)	-0.50 (1.140)	-0.37 (1.334)	-0.54 (1.174)	-0.44 (1.368)	-0.54 (1.140)	-0.77 (1.366)
Day 3	-0.93 (1.439)	-0.56 (1.188)	-0.63 (1.305)	-0.67 (1.177)	-0.67 (1.330)	-0.67 (1.387)	-0.67 (1.301)	-0.78 (1.649)
Day 4	-0.96 (1.400)	-0.63 (1.115)	-0.67 (1.271)	-0.70 (1.137)	-0.63 (1.391)	-0.74 (1.318)	-0.70 (1.265)	-0.81 (1.570)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Negative Control, Non-marketed Adhesive Bandage IP #1
	Comments
	Type of Statistical Test	Other
	Comments	Change in Baseline in Painful Score with Arm Resting by Side was analyzed within-treatment and between-treatment. The within-treatment comparison was performed at each post-baseline time point by comparing the post-baseline scores with the baseline score within each treatment using the paired t-test. The between-treatment comparison was performed by comparing the change from baseline between treatments using a mixed effect analysis of covariance (ANCOVA) model.
Statistical Test of Hypothesis	p-Value	0.666
	Comments
	Method	ANCOVA
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Marketed Adhesive Bandage, Non-marketed Adhesive Bandage IP #1
	Comments
	Type of Statistical Test	Other
	Comments	Change in Baseline in Painful Score with Arm Resting by Side was analyzed within-treatment and between-treatment. The within-treatment comparison was performed at each post-baseline time point by comparing the post-baseline scores with the baseline score within each treatment using the paired t-test. The between-treatment comparison was performed by comparing the change from baseline between treatments using a mixed effect analysis of covariance (ANCOVA) model.
Statistical Test of Hypothesis	p-Value	0.473
	Comments
	Method	ANCOVA
	Comments

6. Secondary Outcome

Title	Change From Baseline in Painful Score With Arm in Normal Motion
Description	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).
Time Frame	Baseline, Day 1, 2, 3 and 4

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Negative Control	Marketed Adhesive Bandage	Marketed Adhesive Bandage IP-1 Benchmark Control 1	Non-marketed Adhesive Bandage IP-Benchmark Control 2	Non-marketed Adhesive Bandage IP #1	Non-marketed Adhesive Bandage IP #2	Non-marketed Adhesive Bandage IP #3	Non-marketed Adhesive Bandage IP #4
Arm/Group Description	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.	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.	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.	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.	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.	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.	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.	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.
Measure Participants	36	36	36	36	36	36	36	36
Day 1	-0.46 (1.319)	-0.14 (0.932)	-0.29 (0.937)	-0.32 (0.863)	-0.29 (0.976)	-0.32 (0.945)	-0.32 (0.945)	-0.43 (1.069)
Day 2	-0.77 (1.177)	-0.35 (0.797)	-0.42 (0.857)	-0.33 (1.000)	-0.50 (0.906)	-0.33 (1.074)	-0.50 (0.860)	-0.62 (1.023)
Day 3	-0.74 (1.318)	-0.33 (1.000)	-0.44 (1.086)	-0.44 (1.013)	-0.52 (1.122)	-0.44 (1.121)	-0.52 (1.087)	-0.52 (1.397)
Day 4	-0.78 (1.251)	-0.44 (0.892)	-0.48 (1.014)	-0.52 (0.893)	-0.48 (1.156)	-0.52 (1.014)	-0.56 (1.013)	-0.56 (1.281)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Negative Control, Non-marketed Adhesive Bandage IP #1
	Comments
	Type of Statistical Test	Other
	Comments	Change from Baseline In Painful Score with Arm in Normal Motion was analyzed within-treatment and between-treatment. The within-treatment comparison was performed at each post-baseline time point by comparing the post-baseline scores with the baseline score within each treatment using the paired t-test. The between-treatment comparison was performed by comparing the change from baseline between treatments using a mixed effect analysis of covariance (ANCOVA) model.
Statistical Test of Hypothesis	p-Value	0.761
	Comments
	Method	ANCOVA
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Marketed Adhesive Bandage, Non-marketed Adhesive Bandage IP #1
	Comments
	Type of Statistical Test	Other
	Comments	Change from Baseline In Painful Score with Arm in Normal Motion was analyzed within-treatment and between-treatment. The within-treatment comparison was performed at each post-baseline time point by comparing the post-baseline scores with the baseline score within each treatment using the paired t-test. The between-treatment comparison was performed by comparing the change from baseline between treatments using a mixed effect analysis of covariance (ANCOVA) model.
Statistical Test of Hypothesis	p-Value	0.456
	Comments
	Method	ANCOVA
	Comments

7. Secondary Outcome

Title	Change From Baseline in Itchy Score
Description	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).
Time Frame	Baseline, Day 1, 2, 3 and 4

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Negative Control	Marketed Adhesive Bandage	Marketed Adhesive Bandage IP-1 Benchmark Control 1	Non-marketed Adhesive Bandage IP-Benchmark Control 2	Non-marketed Adhesive Bandage IP #1	Non-marketed Adhesive Bandage IP #2	Non-marketed Adhesive Bandage IP #3	Non-marketed Adhesive Bandage IP #4
Arm/Group Description	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.	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.	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.	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.	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.	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.	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.	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.
Measure Participants	36	36	36	36	36	36	36	36
Day 1	-0.18 (1.679)	-0.21 (1.663)	-0.32 (1.588)	-0.43 (1.597)	-0.36 (1.615)	-0.25 (1.624)	-0.29 (1.630)	-0.36 (1.592)
Day 2	-0.46 (1.679)	-0.19 (1.767)	-0.31 (1.692)	-0.46 (1.679)	-0.27 (1.801)	-0.27 (1.710)	-0.27 (1.756)	-0.38 (1.675)
Day 3	-0.37 (1.735)	-0.19 (1.733)	-0.22 (1.717)	-0.26 (1.789)	-0.18 (2.091)	-0.04 (1.891)	-0.14 (1.840)	-0.04 (2.047)
Day 4	-0.15 (1.854)	0.00 (1.359)	-0.11 (1.826)	-0.22 (1.847)	-0.26 (1.789)	-0.11 (1.826)	-0.19 (1.841)	0.00 (1.941)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Negative Control, Non-marketed Adhesive Bandage IP #1
	Comments
	Type of Statistical Test	Other
	Comments	Change from Baseline In Itchy Score was analyzed within-treatment and between-treatment. The within-treatment comparison was performed at each post-baseline time point by comparing the post-baseline scores with the baseline score within each treatment using the paired t-test. The between-treatment comparison was performed by comparing the change from baseline between treatments using a mixed effect analysis of covariance (ANCOVA) model.
Statistical Test of Hypothesis	p-Value	0.019
	Comments
	Method	ANCOVA
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Marketed Adhesive Bandage, Non-marketed Adhesive Bandage IP #1
	Comments
	Type of Statistical Test	Other
	Comments	Change from Baseline In Itchy Score was analyzed within-treatment and between-treatment. The within-treatment comparison was performed at each post-baseline time point by comparing the post-baseline scores with the baseline score within each treatment using the paired t-test. The between-treatment comparison was performed by comparing the change from baseline between treatments using a mixed effect analysis of covariance (ANCOVA) model.
Statistical Test of Hypothesis	p-Value	0.325
	Comments
	Method	ANCOVA
	Comments

8. Primary Outcome

Title	Time to Complete Wound Healing
Description	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.
Time Frame	Up to Day 16

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Negative Control	Marketed Adhesive Bandage	Marketed Adhesive Bandage IP-1 Benchmark Control 1	Non-marketed Adhesive Bandage IP-Benchmark Control 2	Non-marketed Adhesive Bandage IP #1	Non-marketed Adhesive Bandage IP #2	Non-marketed Adhesive Bandage IP #3	Non-marketed Adhesive Bandage IP #4
Arm/Group Description	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.	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.	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.	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.	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.	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.	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.	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.
Measure Participants	36	36	36	36	36	36	36	36
Median (Full Range) [Days]	11.8	11.9	6.9	10.9	5.1	12.9	12	15.9

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Negative Control, Non-marketed Adhesive Bandage IP #1
	Comments	All hypothesis tests was conducted at 0.05 level without adjustment of multiple comparisons
	Type of Statistical Test	Other
	Comments	Time to complete healing was analyzed using a survival analysis method. The survival function (cumulative percentage of wounds healed at each time point) was estimated by the Kaplan-Meier method for each treatment separately. The median time to complete healing was derived from the estimated survival functions and be compared using the bootstrap re-sampling method.
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	no adjustments
	Method	Boot-strap sampling method
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Marketed Adhesive Bandage, Non-marketed Adhesive Bandage IP #1
	Comments
	Type of Statistical Test	Other
	Comments	Time to complete healing was analyzed using a survival analysis method. The survival function (cumulative percentage of wounds healed at each time point) was estimated by the Kaplan-Meier method for each treatment separately. The median time to complete healing was derived from the estimated survival functions and be compared using the bootstrap re-sampling method.
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	no adjustments
	Method	Boot-strap sampling method
	Comments

9. Secondary Outcome

Title	Number of Participants With Pain Duration With Arm Resting by Side
Description	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.
Time Frame	Day 1, 2, 3 and 4

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Negative Control	Marketed Adhesive Bandage	Marketed Adhesive Bandage IP-1 Benchmark Control 1	Non-marketed Adhesive Bandage IP-Benchmark Control 2	Non-marketed Adhesive Bandage IP #1	Non-marketed Adhesive Bandage IP #2	Non-marketed Adhesive Bandage IP #3	Non-marketed Adhesive Bandage IP #4
Arm/Group Description	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.	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.	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.	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.	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.	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.	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.	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.
Measure Participants	36	36	36	36	36	36	36	36
Baseline: Brief	18 50%	21 NaN	20 NaN	21 NaN	20 NaN	19 NaN	19 NaN	19 NaN
Baseline: Periodic	2 5.6%	0 NaN	3 NaN	2 NaN	1 NaN	2 NaN	2 NaN	3 NaN
Baseline: Constant	11 30.6%	10 NaN	8 NaN	8 NaN	10 NaN	10 NaN	10 NaN	9 NaN
Day 1: Brief	18 50%	17 NaN	18 NaN	18 NaN	20 NaN	19 NaN	18 NaN	18 NaN
Day 1: Periodic	0 0%	1 NaN	1 NaN	1 NaN	0 NaN	0 NaN	0 NaN	0 NaN
Day 1: Constant	18 50%	18 NaN	17 NaN	17 NaN	16 NaN	17 NaN	18 NaN	18 NaN
Day 2: Brief	17 47.2%	17 NaN	17 NaN	17 NaN	17 NaN	17 NaN	17 NaN	17 NaN
Day 2: Periodic	0 0%	0 NaN	0 NaN	0 NaN	0 NaN	1 NaN	0 NaN	0 NaN
Day 2: Constant	18 50%	18 NaN	18 NaN	18 NaN	18 NaN	17 NaN	18 NaN	18 NaN
Day 3: Brief	16 44.4%	16 NaN	16 NaN	16 NaN	16 NaN	15 NaN	16 NaN	15 NaN
Day 3: Periodic	0 0%	0 NaN	0 NaN	0 NaN	0 NaN	1 NaN	0 NaN	1 NaN
Day 3: Constant	19 52.8%	19 NaN	19 NaN	19 NaN	19 NaN	19 NaN	19 NaN	19 NaN
Day 4: Brief	16 44.4%	16 NaN	16 NaN	16 NaN	16 NaN	16 NaN	16 NaN	17 NaN
Day 4: Periodic	0 0%	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN
Day 4: Constant	18 50%	18 NaN	18 NaN	18 NaN	18 NaN	18 NaN	18 NaN	17 NaN

10. Secondary Outcome

Title	Number of Participants With Pain Duration With Arm in Normal Motion
Description	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.
Time Frame	Day 1, 2, 3 and 4

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Negative Control	Marketed Adhesive Bandage	Marketed Adhesive Bandage IP-1 Benchmark Control 1	Non-marketed Adhesive Bandage IP-Benchmark Control 2	Non-marketed Adhesive Bandage IP #1	Non-marketed Adhesive Bandage IP #2	Non-marketed Adhesive Bandage IP #3	Non-marketed Adhesive Bandage IP #4
Arm/Group Description	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.	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.	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.	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.	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.	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.	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.	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.
Measure Participants	36	36	36	36	36	36	36	36
Baseline: Brief	18 50%	20 NaN	20 NaN	21 NaN	19 NaN	20 NaN	20 NaN	19 NaN
Baseline: Periodic	3 8.3%	1 NaN	2 NaN	2 NaN	2 NaN	2 NaN	2 NaN	2 NaN
Baseline: Constant	10 27.8%	10 NaN	9 NaN	8 NaN	10 NaN	9 NaN	9 NaN	10 NaN
Day 1: Brief	17 47.2%	17 NaN	18 NaN	18 NaN	19 NaN	19 NaN	18 NaN	18 NaN
Day 1: Periodic	0 0%	2 NaN	1 NaN	1 NaN	1 NaN	0 NaN	0 NaN	1 NaN
Day 1: Constant	19 52.8%	17 NaN	17 NaN	17 NaN	16 NaN	17 NaN	18 NaN	17 NaN
Day 2: Brief	16 44.4%	16 NaN	16 NaN	17 NaN	16 NaN	16 NaN	16 NaN	16 NaN
Day 2: Periodic	0 0%	0 NaN	0 NaN	0 NaN	0 NaN	1 NaN	0 NaN	0 NaN
Day 2: Constant	19 52.8%	19 NaN	19 NaN	18 NaN	19 NaN	18 NaN	19 NaN	19 NaN
Day 3: Brief	16 44.4%	15 NaN	16 NaN	16 NaN	16 NaN	15 NaN	16 NaN	15 NaN
Day 3: Periodic	0 0%	1 NaN	0 NaN	0 NaN	0 NaN	1 NaN	0 NaN	1 NaN
Day 3: Constant	19 52.8%	19 NaN	19 NaN	19 NaN	19 NaN	19 NaN	19 NaN	19 NaN
Day 4: Brief	16 44.4%	16 NaN	16 NaN	16 NaN	16 NaN	16 NaN	16 NaN	17 NaN
Day 4: Periodic	0 0%	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN
Day 4: Constant	18 50%	18 NaN	18 NaN	18 NaN	18 NaN	18 NaN	18 NaN	17 NaN

Adverse Events

Time Frame	Up to Day 28
Adverse Event Reporting Description	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.
Arm/Group Title	All Randomized Participants
Arm/Group Description	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.
All Cause Mortality
	All Randomized Participants
	Affected / at Risk (%)	# Events
Total	0/36 (0%)
Serious Adverse Events
	All Randomized Participants
	Affected / at Risk (%)	# Events
Total	0/36 (0%)
Other (Not Including Serious) Adverse Events
	All Randomized Participants
	Affected / at Risk (%)	# Events
Total	34/36 (94.4%)
General disorders
Oedema	1/36 (2.8%)
Pyrexia	1/36 (2.8%)
Injury, poisoning and procedural complications
Skin abrasion	21/36 (58.3%)
Thermal burn	2/36 (5.6%)
Animal scratch	1/36 (2.8%)
Arthropod bite	1/36 (2.8%)
Musculoskeletal and connective tissue disorders
Pain in extremity	1/36 (2.8%)
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain	1/36 (2.8%)
Skin and subcutaneous tissue disorders
Erythema	28/36 (77.8%)
Rash	11/36 (30.6%)
Pruritus	2/36 (5.6%)
Blister	1/36 (2.8%)
Dry skin	1/36 (2.8%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.