Comparison between 3 surgical treatments in stable vitiligo patients

• Conditions: Vitiligo,

• Registration Number: CTRI/2019/11/021900
• Lead Sponsor: GCS Medical college Hospital and Research center

Brief Summary

This is an observational, comparative, randomised tertiary care hospital based prospective

study of stable vitiligo patients presenting to the department of dermatology

treated with either one of follicular unit transplantation, ultrathin skin grafting or

dermabrasion followed by topical 5-flurouracil. The aim is to observe and compare the efficacy of Follicular Unit Transplantation, ultrathin skin

grafting and dermabrasion followed by topical 5-flurouracil in patients of stable vitiligo.

Randomisation: the participants will be randomised in 3 groups by sequential allocation. If

the participant has any contraindication to the allotted group, participant will be allotted to

next group on discretion of the principal investigator.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-11-15
• Last Update Posted: 2021-01-25

Recruitment & Eligibility

• Status: Other
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Patients with stable vitiligo ( no new lesions, no progression of existing lesions for past 1 year) 2.
• Patients >18 years.

Exclusion Criteria

• Patients with active vitiligo 2.
• Patients with history of Koebner phenomenon 3.
• Patients with keloidal tendency 4.
• Patients with a history of bleeding disorders 5.
• Presence of concomitant local or systemic infections 6.
• Presence of uncontrolled diabetes 7.
• Pregnant or lactating patients.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
This will be done at every follow-up.	Every month after procedure for 3 months
Response evaluation:	Every month after procedure for 3 months
25-50 – fair response (grade 2)	Every month after procedure for 3 months
1.By calculating the percentage area of reduction in the area of vitiligo.	Every month after procedure for 3 months
2.Qualitative assessment:	Every month after procedure for 3 months
0-25 – poor response (grade 1)	Every month after procedure for 3 months
50-75 – good response (grade 3)	Every month after procedure for 3 months
75-100 – excellent response (grade 4)	Every month after procedure for 3 months
4. Hair repigmentation	Every month after procedure for 3 months

Secondary Outcome Measures

Name	Time	Method
Occurrence of any side effects including infection, graft loss, healing delay, extension of lesion	Every month after procedure for 3 months

Trial Locations

Locations (1)

GCS Medical college, hospital and research center; 🇮🇳 Ahmadabad, GUJARAT, India

GCS Medical college, hospital and research center

🇮🇳Ahmadabad, GUJARAT, India

Dr Nishi Trivedi

Principal investigator

9328061865

nishi.trivedi04@gmail.com