A clinical trial to study the safety and efficacy of ReliDerm®M (Autologous cultured melanocyte graft) in patients with stable vitiligo
Phase 1
Completed
- Conditions
- Health Condition 1: null- Stable Vitiligo
- Registration Number
- CTRI/2009/091/000638
- Lead Sponsor
- Reliance Life Sciences PvtLtd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 20
Inclusion Criteria
1. Male or female patients of 12-50 years
2. Patients with minimum of 2 lesions at least 10 cm apart
3. Patient with patch size of 8-12 cm2
Exclusion Criteria
1. Patients with history of bleeding diasthesis
2. Treatment with systemic corticosteroids or any other re-pigmentation therapy during the last 30 days prior to enrollment
3. Infection with Human Immunodeficiency Virus, Hepatitis B or Hepatitis C
4. Patients with known sensitivity to bovine serum
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Re-pigmentation after application of ReliDerm®M in comparison to control groupTimepoint: To achieve at least 70% area of re-pigmentation at the test site is defined as success
- Secondary Outcome Measures
Name Time Method 1. To study the safety of ReliDerm®M <br/ ><br>2. To study the re-pigmentation patterns <br/ ><br>3. To study recurrence of vitiligo at recipient siteTimepoint: Month 3, 6,12