Skip to content

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

A COMPARATIVE 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

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/02/040232
Enrollment
30
Registered
2022-02-11
Start date
Unknown
Completion date
Unknown
Last updated
2022-02-21

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

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: manual dermabration: therapy once at week 0 follow up at 4,8,12,16,24 weeks Control Intervention1: tattooing pen: therapy once at week 0 follow up at 4,8,12,16,24 weeks

Sponsors

PGIMER
Lead Sponsor

Eligibility

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

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

Secondary

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

Countries

India

Contacts

Public ContactAkshay Meena

PGIMER Chandigarh

parsad@me.com9876060361

Outcome results

None listed

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