Micro-needling with 5‑fluorouracil versus strong topical steroid for limited vitiligo
Effectiveness of Combining Micro Needling With 5 Fluorouracil Versus Potent Topical Steroids; in Treating Limited Vitiligo- Randomised Controlled Study
EARLY_PHASE1 · Combined Military Hospital (CMH) institute of Medical Sciences Bahawalpur Pakistan · NCT07398807
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_PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 4 Years to 70 Years |
| Sex | All |
| Sponsor | Combined Military Hospital (CMH) institute of Medical Sciences Bahawalpur Pakistan (other) |
| Locations | 1 site (Chak Four Hundred Fifty-four) |
| Trial ID | NCT07398807 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: Small case series and nonrandomized reports have shown repigmentation with microneedling plus 5‑FU, but high-quality randomized data remain limited.
Eligibility criteria
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 this trial is running
Chak Four Hundred Fifty-four
- CMH Bahawalpur — Chak Four Hundred Fifty-four, Pakistan (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Vitiligo, Limited, Microneedling, 5-FU