Electrofulguration- A novel technique in recipient site preparation in vitiligo surgery.

Not yet recruiting

Conditions: Vitiligo,

Registration Number: CTRI/2020/01/022671

Lead Sponsor: Department of Dermatology Venereology and Leprology PGIMER

Brief Summary: Vitiligo is a common acquired disorder of pigmentation and causes considerable cosmetic disfigurement and psychological distress to patients. Surgical therapy is a good treatment option for stable patches not responding to conventional methods of therapy. The gold standard of recipient site preparation in NCES procedure is manual dermabrasion. However our centre has reported good outcome with recipient site preparation using electrofulguration assisted dermabrasion. In this study we propose to compare the repigmentation rates using the two methods of recipient site preparation. In addition, the keratinocytes in the cell suspension are a rich source of various growth factors which stimulate the melanocytes to produce melanin and cause repigmentation. Hence we wish to correlate the levels of growth factors like SCF, bFGF, Endothelin 1 in the cell suspension with the repigmentation rates post surgery.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 30

Inclusion Criteria

Clinical diagnosis of segmental or non segmental vitiligo 2 independent patchesbof 3x 3 cm size each present symmetrically or unilaterally over the same part or a single patch ofvsize 6x6 cm Stable leaions for more than 1 year Disease is not responding to medical therapy for 12 weeks or residual patches post medical therapy.

Exclusion Criteria

Pregnancy and lactation History of unstable cardiac diseasevor pacemakers Patients with active disease VIDA more than 1 History of hypertrophic scars or keloid Skin infection Patients with unrealistic expectations History of bleeding disorders Patients on anticoagulants Immunosuppressed patients Patients still in wash off period of therapy that is 4 weeks for topical and 12 weeks for systemic therapy.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the percentage of patients achieving 75 percent repigmentation with respect to the two different methods at 24 weeks of follow up post treatment	0 4 8 12 16 24 weeks

Secondary Outcome Measures

Name	Time	Method
To assess whether the extent of repigmentation has any correlation to the expression levels of growth factors which are SCF, bFGF, endothelin 1	0 4 8 12 16 24 weeks
To evaluate the repigmentation patterns of the lesions pre and post post procedure by dermoscopy and to ennumerate the dermatoscopic markers of repigmentation as well markers of success of the procedure	0 4 8 12 16 24 weeks

Trial Locations

Locations (1): PGIMER, Chandigarh
🇮🇳
Chandigarh, CHANDIGARH, India
PGIMER, Chandigarh
🇮🇳Chandigarh, CHANDIGARH, India
Anubha Dev
Principal investigator
8754841807
anubhadev94@gmail.com