Effectiveness of Micro-needling With 5 Fluorouracil Versus Potent Topical Steroids in the Treatment of Limited Vitiligo
NCT07398807 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2026-02-17
Summary
The goal of this clinical trial is to learn how well 5 fluorouracil (5FU) with micro-needling works to treat limited vitiligo as compared to strong steroid applied on skin. It will also learn about the safety of both these treatments. The main questions it aims to answer are:
* How well does 5FU with microneedling work to treat vitiligo by returning pigmentation in vitiligo patches as compared to steroid?
* What is participant's satisfaction when treated with 5FU with microneedling as compared to steroid?
* What skin problems do participants have when treated with FU with microneedling and steroid?
Researchers will compare 5FU with microneedling to steroid application to see how well both work to return pigment in vitiligo patches.
Participants will be divided into two groups. For Group A, 5 FU will be rubbed and absorbed on the vitiligo patch after micro-needling every 2 weeks.
For group B, topical 0.05% clobetasol propionate ointment will be applied twice a day on the vitiligo patches for 12 weeks.
Vitiligo patches will be assessed at the start of trial and then after 12 weeks of treatment.
Conditions
- Vitiligo
Interventions
- DRUG
-
Microneedling with 5-fluorouracil
Micro-needling will be done, 2 passes will be made on the affected patch of vitiligo with 5 FU. Not more than 0.5 ml 5FU will be used during each session. Session will be repeated 2 weekly for 6 months.
- DRUG
-
Topical application of 0.05% Clobetasol propionate
Topical 0.05% clobetasol propionate ointment will be applied twice a day on the vitiligo patches.1 finger-tip unit (FTU) will be used for 2% BSA i.e., 0.5 grams.
Sponsors & Collaborators
-
Combined Military Hospital (CMH) institute of Medical Sciences Bahawalpur Pakistan
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 4 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-08-08
- Primary Completion
- 2026-02-28
- Completion
- 2026-02-28
Countries
- Pakistan
Study Locations
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