None listed
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Healthy subjects with healthy skin on the studied anatomic unit (free of eczema, wounds & any other inflammatory scar) 2. Age group of 18 to 55 years, 12 male and 12 female subjects. 3. Compliance with the study procedures involved
Exclusion criteria
Exclusion criteria: 1. Pregnant and lactating women 2. Subjects with any other skin disorders. 3. Use of any other topical agents for any skin related conditions (at the site of application of patch) during the past 30 days.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Erythema, dryness, wrinkles Oedema 2. Mean Irritation Index Scoring System (0-4): 0: No Reaction 1: Very slight erythema/dryness/oedema 2: Slight erythema/dryness/oedema 3: Moderate erythema/dryness/oedema 4: Severe erythema/dryness/oedema Evaluation Process: 3. Mean scores for erythema, dryness, wrinkles, and oedema will be calculated for T1, T2, and T8 days 4. Scores will be assessed for the test sample and controls (including 1% sodium lauryl sulfate).Timepoint: Screening T0 (Before PatchApplication) T1 (0 Hours Post-Patch Removal) T2 (24 Hours Post-Patch Removal) T8 (1 Week Post-Patch Removal) | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse event monitoringTimepoint: T1 (0 Hours Post-Patch Removal) T2 (24 Hours Post-Patch Removal) T8 (1 Week Post-Patch Removal) | — |
Countries
India
Contacts
DK Elite Health Care Centre