RecruitingEarly Phase 1NCT07398807

Effectiveness of Micro-needling With 5 Fluorouracil Versus Potent Topical Steroids in the Treatment of Limited Vitiligo

Effectiveness of Combining Micro Needling With 5 Fluorouracil Versus Potent Topical Steroids; in Treating Limited Vitiligo- Randomised Controlled Study

Sponsor

Combined Military Hospital (CMH) institute of Medical Sciences Bahawalpur Pakistan

Enrollment

40 participants

Start Date

Aug 8, 2025

Study Type

INTERVENTIONAL

Conditions

Vitiligo

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.

Eligibility

Min Age: 4 YearsMax Age: 70 Years

Inclusion Criteria3

Patients willing to participate in the study
Patients of age group of 05 -70 years.
Vitiligo involving less than or equal to 10% body surface area.

Exclusion Criteria7

Patients using or have used other treatments for vitiligo
Pregnant women or lactating women
Patients with unstable vitiligo
Patients on immunosuppressant medications due to other diseases
Patients having anemia, immunosuppression, bleeding disorder, taking anticoagulants or anti-platelet drugs or having epilepsy
Patient having history of keloids or hypertrophic scars
Patients with history of hypersensitivity to either of the drugs

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Interventions

DRUGMicroneedling 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.

DRUGTopical 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.