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.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 4 Years to 70 Years |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | Combined Military Hospital (CMH) institute of Medical Sciences Bahawalpur Pakistan Academic / other |
| Locations | 1 site (Chak Eighty-seven -Twelve Left) |
| Status | Recruiting |
| Started | August 8, 2025 |
| Main results expected | February 2026 |
| Study ends | February 2026 |
| Registry record updated | February 17, 2026 |
| Trial ID | NCT07398807 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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.