A Study to Assess Wound Healing Efficacies of Different Adhesive Bandages

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

Population: The Intent-to-Treat (ITT) set include all participants who received laser-induced wounds and started the study treatments. As planned, for this outcome measure, the data was reported for each bandage separately.

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

Population: The Intent-to-Treat (ITT) set include all participants who received laser-induced wounds and started the study treatments. Here 'n' (number analyzed) included all evaluable participants analyzed at specified timepoints. As planned, for this outcome measure, the data was reported for each bandage separately.

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

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

Population: The Intent-to-Treat (ITT) set include all participants who received laser-induced wounds and started the study treatments. Here 'n' (number analyzed) included all evaluable participants analyzed at specified timepoints. As planned, for this outcome measure, the data was reported for each bandage separately.

Change from baseline in composite scar score was reported. It was calculated as the sum of the individual parameters on the Manchester Scar Scale (Color ranges 1 \[perfect\] to 4 \[gross mismatch\]), Finish ranges 1 \[matte\] to 2 \[shiny\], Contour ranges 1 \[Flush with surrounding skin\] to 4 \[keloid\], Distortion ranges 1 \[none\] to 4 \[severe\] and Texture ranges 1 \[normal\] to 4 \[hard\]). Composite Scar Scores range from 5 to 18, with 5 representing clinically best scars and 18 representing clinically worst scars.

Time frame: Baseline and Day 28

Population: The Intent-to-Treat (ITT) set include all participants who received laser-induced wounds and started the study treatments. Here 'n' (number analyzed) included all evaluable participants analyzed at specified timepoints. As planned, for this outcome measure, the data was reported for each bandage separately.

Change from baseline in 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

Population: The Intent-to-Treat (ITT) set include all participants who received laser-induced wounds and started the study treatments. Here 'n' (number analyzed) included all evaluable participants analyzed at specified timepoints. As planned, for this outcome measure, the data was reported for each bandage separately.

Change from baseline in Painful Score based on participants self-assessment questionnaire score (question 3) was reported. Participants were asked to rate each wound for pain/soreness in normal position as score from 0 (no pain) to 10 (severe pain).

Time frame: Baseline, Day 1, 2, 3 and 4

Population: The Intent-to-Treat (ITT) set include all participants who received laser-induced wounds and started the study treatments. Here 'n' (number analyzed) included all evaluable participants analyzed at specified timepoints. As planned, for this outcome measure, the data was reported for each bandage separately.

Change from baseline in painful score based on participants self-assessment questionnaire score (question 1) was reported. Participants were asked to rate each wound for pain/soreness in resting position as score from 0 (no pain) to 10 (severe pain).

Time frame: Baseline, Day 1, 2, 3 and 4

Population: The Intent-to-Treat (ITT) set include all participants who received laser-induced wounds and started the study treatments. Here 'n' (number analyzed) included all evaluable participants analyzed at specified timepoints. As planned, for this outcome measure, the data was reported for each bandage separately.

Change from Baseline in 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

Population: The Intent-to-Treat (ITT) set include all participants who received laser-induced wounds and started the study treatments. Here 'n' (number analyzed) included all evaluable participants analyzed at specified timepoints. As planned, for this outcome measure, the data was reported for each bandage separately.

Participants were asked to rate the pain as either brief, periodic, or constant in arm normal motion with the Self-Assessment Questionnaire (question 4). Number of participants with pain duration (brief, periodic, or constant) with arm in normal motion was reported.

Time frame: Day 1, 2, 3 and 4

Population: The Intent-to-Treat (ITT) set include all participants who received laser-induced wounds and started the study treatments. Here 'n' (number analyzed) included all evaluable participants analyzed at specified timepoints. As planned, for this outcome measure, the data was reported for each bandage separately.

Participants were asked to rate the pain as either brief, periodic, or constant in arm resting position with the Self-Assessment Questionnaire (question 2). Number of participants with pain duration (brief, periodic, or constant) with arm resting by side was reported.

Time frame: Day 1, 2, 3 and 4

Population: The Intent-to-Treat (ITT) set include all participants who received laser-induced wounds and started the study treatments. Here 'n' (number analyzed) included all evaluable participants analyzed at specified timepoints. As planned, for this outcome measure, the data was reported for each bandage separately.