NCT07398807 Effectiveness of Micro-needling With 5 Fluorouracil Versus Potent Topical Steroids in the Treatment of Limited Vitiligo
| NCT ID | NCT07398807 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Combined Military Hospital (CMH) institute of Medical Sciences Bahawalpur Pakistan |
| Condition | Vitiligo |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2025-08-08 |
| Primary Completion | 2026-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 40 participants in total. It began in 2025-08-08 with a primary completion date of 2026-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Frequently Asked Questions
Who can join the NCT07398807 clinical trial?
This trial is open to participants of all sexes, aged 4 Years or older, up to 70 Years, studying Vitiligo. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07398807 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07398807 currently recruiting?
Yes, NCT07398807 is actively recruiting participants. Visit ClinicalTrials.gov or contact Combined Military Hospital (CMH) institute of Medical Sciences Bahawalpur Pakistan to inquire about joining.
Where is the NCT07398807 trial being conducted?
This trial is being conducted at Chak Four Hundred Fifty-four, Pakistan.
Who is sponsoring the NCT07398807 clinical trial?
NCT07398807 is sponsored by Combined Military Hospital (CMH) institute of Medical Sciences Bahawalpur Pakistan. The trial plans to enroll 40 participants.