Clinical trial NCT03717025: Comparison of Surgical Methods on Resistant Sites in Stable Vitiligo Patients
Official title: A Comparative Study Between Autologous Mini Punch Grafting, Suction Blister Grafting and Non-Cutured Epidermal Cell Suspension on Resistant Sites in Stable Vitiligo
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Vitiligo
Keywords: ACRAL
Lead sponsor: PGIMER
Sponsor class: UNKNOWN
First posted: 2018-10-23
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Repigmentation At Surgery Site
timeFrame: Repigmentation will be assessed at 12 weeks.
Secondary outcomes:
measure: Color Matching of Repigmented Area
timeFrame: Assessment at 12 weeks.
measure: Patient's Quality of Life Post Surgery
timeFrame: Assessment at 12 weeks.
measure: Patient's Quality of Life Post Surgery
timeFrame: Assessment at 12 weeks.
measure: PATTERN OF REPIGMENTATION
timeFrame: Assessment at 12 weeks.
measure: ADVERSE EVENTS
timeFrame: Assessment at 4, 8 and 12 weeks.
Other outcomes:
Locations:
city: Chandigarh
country: India
facility: Post Graduate Institute of Medical Education and Research
Study officials:
References: