Clinical trial Recruiting at 1 site Early Phase 1 Interventional Ages 4 to 70

Micro-needling with 5‑fluorouracil versus strong topical steroid for limited vitiligo

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

Run by Combined Military Hospital (CMH) institute of Medical Sciences Bahawalpur Pakistan · NCT07398807 · Data updated 2026-11-12

This trial will test whether micro-needling plus 5‑fluorouracil or a potent topical steroid works better to restore pigment in people with limited, stable vitiligo.

More Vitiligo trials

Quick facts

PhaseEarly Phase 1
Study typeInterventional
Ages4 Years to 70 Years
SexAll
Enrollment40 (estimated)
SponsorCombined Military Hospital (CMH) institute of Medical Sciences Bahawalpur Pakistan
Academic / other
Locations1 site (Chak Eighty-seven -Twelve Left)
StatusRecruiting
StartedAugust 8, 2025
Main results expectedFebruary 2026
Study endsFebruary 2026
Registry record updatedFebruary 17, 2026
Trial IDNCT07398807 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

People aged 5–70 with stable vitiligo involving ≤10% of body surface area who are willing to undergo micro-needling or topical steroid treatment and attend follow-up visits are ideal candidates.

Probably not a fit

Patients with unstable or widespread vitiligo, pregnant or breastfeeding individuals, those on immunosuppressants, with bleeding disorders, a history of keloids, or recent vitiligo treatments are excluded and unlikely to benefit from this protocol.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This single-center, randomized early-phase trial will enroll about 40 patients with stable vitiligo affecting 10% or less of body surface area and assign them to two treatment groups. One group will receive micro-needling with topical 5‑fluorouracil applied to the lesions every two weeks, while the other will apply 0.05% clobetasol propionate ointment twice daily. Investigators will record baseline photos and VASI scores, then monitor repigmentation, patient satisfaction, and skin side effects over follow-up visits. Safety assessments and adverse event recording will be included to compare tolerability between the two approaches.

Why it matters

Potential benefit: If successful, this approach could provide a low-cost, localized treatment that restores pigment in limited vitiligo with similar or better results than potent topical steroids.

How similar studies have gone: Small case series and nonrandomized reports have shown repigmentation with microneedling plus 5‑FU, but high-quality randomized data remain limited.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* 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 Criteria:

* 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

Where it's running

  • CMH Bahawalpur
    Chak Eighty-seven -Twelve Left, Pakistan
    Recruiting

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.