A STUDY BETWEEN RECEPIENT SITE PREPARATION USING MANUAL DERMABRASION AND TATTOOING PEN IN AUTOLOGOUS NON CULTURED EPIDERMAL CELL SUSPENSION PROCEDURE IN STABLE VITILIGO PATIENTS: A RANDOMIZED DOUBLE BLINDED STUDY

Phase 2

Conditions: Health Condition 1: O- Medical and Surgical

Registration Number: CTRI/2022/02/040232

Lead Sponsor: PGIMER

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1)Patients with a clinical diagnosis of segmental or non-segmental vitiligo and

2)Patients with two independent patches of size 3x3 cm or more present either symmetrically or unilaterally over same body site or patients with a single patch of 6 x 6 cm or more.

3)Vitiligo lesions have been stable for 1 year or more. Stability is defined as no progression of lesions for at least 1 year or more, with or without spontaneous repigmentation and absence of new koebner phenomenon.

4)Disease should have failed repigmentation with medical treatment, or there are residual patches (after medical therapy) of vitiligo.

5)Size of vitiligo patches <100cm2.

6)Wash off period of 4 weeks for topical therapy and 12 weeks for systemic therapy has passed

Exclusion Criteria

1)Pregnancy and lactation

2)Patient with active disease i.e. VIDA 1+ or more

3)History of hypertrophic scars or keloidal tendency

4)Current skin infections at donor or recipient site

5) Patients with unrealistic expectations

6) History of bleeding disorders

7) Patients on anticoagulants

8) Immunosuppressed patients

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.The proportion of patients achieving 75% repigmentation at 24 weeks follow-up in both groups.Timepoint: 24 weeks

Secondary Outcome Measures

Name	Time	Method
1.The proportion of patients achieving 50% repigmentation at 24 weeks follow-up in both groups. <br/ ><br>2.To assess the color matching of repigmented area. <br/ ><br>3.To assess the patient satisfaction (patient global assessment) and to compare the quality of life assessement post procedure with that of pre procedure. <br/ ><br>4.To monitor adverse events if any. <br/ ><br>5.To compare the effect of recipient site preparation on acral vs non-acral areas. <br/ ><br> <br/ ><br>Timepoint: 24 weeks