Health Condition 1: L906- Striae atrophicae
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adults 18–45 years. 2. Visible stretch marks (striae rubra or alba) on belly/hips/thighs/knees and shoulders, present Greater than or equal to 3 months to 1 years due to change in the body weight, Post Partum Changes. 3. Willing to refrain from other topical treatments/procedures on test areas during the study. 4. Able to comply and sign informed consent.
Exclusion criteria
Exclusion criteria: 1. Pregnant or breastfeeding. 2. Known allergy to any ingredient of test product. 3. Recent Greater than or equal to 3 topical retinoid, steroid, or procedural treatment on target areas. 4. Active dermatitis or infection in test area. 5. Participation in another clinical study within 30 days.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change from baseline, Week 2 and Week 4 in photo graded Visual Improvement Scale (VIS) and or percent change in stretch-marks. (For those who give consent)Timepoint: Baseline (Day 0), Visit 2 (week 2), Visit 3 (28 days) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Skin texture: Mean percentage improvement - baseline and Week 4 (target: approx 25 percent improvement). Report mean ± SD and CI. (instrument plus Self-assessment) 2. Dryness or tightness: Proportion of participants demonstrating self-perceived improvement and an increase in skin hydration as measured by a corneometer at baseline and Week 4. 3. Elasticity (Cutometer): Mean percentage change in R2 at Week 4 (target approx 15 percent) Baseline & week 4 4. VAS – Tightness, dryness, and itching (0–10) – Baseline, Week 2 and Week 4 5. 5-point Likert for agreement with statements (e.g., elastic or comfortable). Week 4 6. DLQI – Dermatology Life Quality Index (Baseline and week 4) 7. Safety: number and percentage of subjects with local irritation or other AEs.Timepoint: Baseline (Day 0), Visit 2 (week 2), Visit 3 (28 days) | — |
Countries
India
Contacts
DK Elite Health Care Centre