None listed
Conditions
Interventions
Intervention1: Acne Scar Serum: The test product is an acne scar serum which is claimed to be effective in healing acne scars.
The actives in the test product are (Water (and) Dextran (and) Tripeptide
Sponsors
A Menarini India Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Volunteers with acne scars with or without Post Inflammatory Hyper-pigmentation (all types). 2. Volunteers with Post Inflammatory Hyper-pigmentation (at least 70% needs to be included). 3. Patients without any scar treatment done in the past 6 months.
Exclusion criteria
Exclusion criteria: 1. Pregnant women , Lactating mothers. 2. Known sensitivity to any of the ingredients in the study product. 3. Presence of other skin conditions, diseases, or medical conditions that (per protocol or in the opinion of the Investigator) may require concurrent therapy, interfere with the evaluation of the study medication, or compromise subject safety.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Clinical evaluation by Dermatologist using a scale, at all visits. 2. Instrumental evaluation 1. Reduction in acne scars, depth and volume of acne using 3D Imaging at all visits. 2. Reduction in Post Inflammatory Hyper pigmentation (PIH), caused due to acne, by measuring L value using 3D imaging 3. Clinical Photography at all visits. 4. Non-invasive Ultrasound biomicroscopy of the skin at baseline and 90 days. (10 complete cases) 3. Self Assessment Questionnaire for efficacy. Timepoint: Day 0 Day 30 Day 60 Day 90 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Safety Endpoints Clinical evaluation for tolerance. Self-assessment Questionnaire for in use tolerance. Timepoint: Day 0 Day 30 Day 60 Day 90 | — |
Countries
India
Contacts
Public ContactSanjay Chavare
A. Menarini India Private Limited
Outcome results
None listed