Effectiveness of Micro-needling With 5 Fluorouracil Versus Potent Topical Steroids in the Treatme… (NCT07398807) | Clinical Trial Compass
RecruitingEarly Phase 1
Effectiveness of Micro-needling With 5 Fluorouracil Versus Potent Topical Steroids in the Treatment of Limited Vitiligo
Pakistan40 participantsStarted 2025-08-08
Plain-language 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.
Who can participate
Age range
4 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Re-pigmentation of vitiligo patches of patients treated with 5FU with micro-needling versus potent topical steroids at week 12 as assessed by decrease in VASI (Vitiligo Area Scoring Index) scores, ranging from score 0 to 100.
Timeframe: From enrollment to the end of treatment at 6 months
Trial details
NCT IDNCT07398807
SponsorCombined Military Hospital (CMH) institute of Medical Sciences Bahawalpur Pakistan