Health Condition 1: L81- Other disorders of pigmentation
Conditions
Interventions
Intervention1: Tocotrienol Rich Fraction MCT (Medium Chain Triglycerides) GML (Glyceryl Monolaurate) Ascorbyl Palmitate: The Finns chamber patch, containing 25 microlitres of the test product and a po
Sponsors
Orah Nutrichem Pvt. Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Healthy volunteers 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 volunteers. 3.Compliance with the study procedures involved.
Exclusion criteria
Exclusion criteria: 1.Pregnant and lactating women 2.Volunteers 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 using Microsoft Excel 2010 and GraphPad Prism software. 4. Scores will be assessed for the test sample (ORAH GLO E) and controls (including 1% sodium lauryl sulfate).Timepoint: Screening T0 (Before Patch Application) 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
Public ContactDr Gayathri Sivakumar
DK Elite Health Care Centre
Outcome results
None listed