CTRI Clinical Trial Report
Comprehensive clinical evaluation of safety and efficacy for our skincare formulations registered under the Clinical Trials Registry of India.
Key Study Highlights
- Objective: Evaluate in-vivo dermatological safety and efficacy of the product for outcomes such as reduction in wrinkles, improvement in skin brightness, hydration, elasticity and even-tone (specific endpoints vary by product).
- Population: 36 healthy volunteers (approx. 26 female / 10 male).
- Age Range:
Anti-ageing products – 35 – 55 years.
Brightening / pigment products – 18 – 40 years.
- Design: Double-blind, non-comparative; subjects served as their own control.
- Duration:
Anti-ageing trials – 42 days after first application.
Brightening trials – 28 days after first application.
Methodology
- Subject Selection:
Inclusion: healthy volunteers with target skin concerns (e.g., crow’s feet wrinkles, dry skin, or visible post-inflammatory hyperpigmentation ≥ 3 mm).
Exclusion: known allergies, relevant medical conditions, conflicting treatments.
- Randomisation & Blinding: Double-blind; each subject acted as own reference.
- Procedures & Assessments:
Subject Self-Evaluation questionnaires.
Dermatological Evaluation – cosmetic acceptability & efficacy.
Instrumental tests depending on product:
Chromametry / Mexametry – measure pigmentation & redness.
Corneometry – skin hydration.
Cutometry – elasticity / firmness.
Tewametry – water-loss barrier.
Digital Photographs at each visit.
Examination Schedule
Typical visit pattern:
- Screening & T0 – registration, consent, baseline photography.
- T+14 Days (or T+7 for 28-day studies) – interim assessments.
- T+28 Days – mid or final (for 28-day studies).
- T+42 Days – final (for 42-day studies).