Comparison of Surgical Methods on Resistant Sites in Stable Vitiligo Patients

Post Graduate Institute of Medical Education and Research, Chandigarh

Status: Unknown

Conditions: Vitiligo

Treatments: Procedure: SUCTION BLISTER EPIDERMAL GRAFTING; Procedure: MINI PUNCH GRAFTING; Procedure: NON CULTURED EPIDERMAL CELL SUSPENSION

Study type: Interventional

Funder types: Other

Identifiers

NCT03717025

INT/IEC/2017/1251

Details and patient eligibility

About

Comparing the Efficacy of Three Different Surgical Methods on Resistant Sites in Stable Vitiligo.

Full description

The treatment of vitiligo includes both medical and surgical modalities, whose goal is to restore melanocytes to the depigmented skin so that the epidermis restores back to normal morphology and functions. Although medical treatment is the main stay of treatment, it is not effective in all and residual lesions need augmented surgical treatment later for further completion of repigmentation.

Now a day surgical modalities have become treatment of choice for stable vitiligo not responding to medical treatment although there are numerous sites which do not respond that well to surgical procedure as well. The investigators ought to compare the efficacy of 3 well established surgical methods i.e. Mini Punch Grafting vs Suction Blister Epidermal Grafting vs Non Cultured Epidermal cell Suspension on stable vitiligo patches localized to acral areas and bony prominences like elbows, knees and ankles. Out of all the vitiligo patches in a given participant, 3 different patches on acral and bony areas will be chosen and participants will be treated with 3 different methods.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Subjects with clinical diagnosis of focal, segmental or generalized vitiligo
2. Patients with lesions of size > 1.5cm x 1cm present on acral areas and bony prominences.
3. Vitiligo lesions has been stable for 1 year.
4. Disease not responding to medical treatment, or there are residual patches (after medical therapy) of vitiligo which inturn are located on acral areas and bony prominences.
5. Maximum size of vitiligo patches to be selected for surgery will not be >100cm2.

Exclusion criteria

1. Age less than 18 years
2. Pregnancy and lactation
3. Patient with actively spreading vitiligo
4. History of Koebnerisation
5. History of hypertrophic scars or keloidal tendency
6. Bleeding disorders
7. Patients with unrealistic expectation

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 3 patient groups

Mini Punch Grafting

Active Comparator group

Treatment:

Procedure: MINI PUNCH GRAFTING

Suction Blister Epidermal Grafting

Active Comparator group

Treatment:

Procedure: SUCTION BLISTER EPIDERMAL GRAFTING

Non Cultured Epidermal Cell Suspension

Active Comparator group

Treatment:

Procedure: NON CULTURED EPIDERMAL CELL SUSPENSION