A clinical trial to study the safety and efficacy of ReliDermÂ®M (Autologous cultured melanocyte graft) in patients with stable vitiligo

Prospective, open-labeled, randomized, multi-centric clinical trial for Assessment of safety and efficacy of ReliDermÂ®M in the treatment of stable vitiligo

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2009/091/000638

Enrollment

Registered

2009-08-20

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Stable Vitiligo

Interventions

Intervention1: ReliDermÂ®M (Autologous cultured melanocyte graft): A monolayered melanocyte graft comprising of cultured melanocytes on a 9 cm sq poly (DL-lactic acid) film. This is one time graft tra

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Re-pigmentation after application of ReliDermÂ®M in comparison to control groupTimepoint: To achieve at least 70% area of re-pigmentation at the test site is defined as success	—

Secondary

Measure	Time frame
1. To study the safety of ReliDermÂ®M 2. To study the re-pigmentation patterns 3. To study recurrence of vitiligo at recipient siteTimepoint: Month 3, 6,12	—

Countries

India

Contacts

Public ContactDr Chandra Viswanathan

Reliance Life Sciences Pvt. Ltd.

chandra.viswanathan@ril.com02240678352

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026