Actively Recruiting
Effectiveness of Combining Micro Needling With 5 Fluorouracil Versus Potent Topical Steroids in Treating Limited Vitiligo - Randomised Controlled Study
Led by Combined Military Hospital (CMH) institute of Medical Sciences Bahawalpur Pakistan · Updated on 2026-02-17
40
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating how well 5 fluorouracil (5FU) combined with micro-needling works to treat limited stable vitiligo compared to the use of strong topical steroids. The study aims to find a cost-effective treatment for patients with less than 10% body surface area affected by vitiligo. It will also monitor participant satisfaction and safety issues related to both treatments. Participants will be randomly assigned to one of two groups. Group A will receive micro-needling with 5FU applied every two weeks for six sessions. The procedure involves numbing the skin, cleaning the lesion, using a micro-needling device, and applying up to 0.5 ml of 5FU per session, followed by a sterile dressing. Group B will apply 0.05% clobetasol propionate ointment twice daily for 12 weeks, using a measured amount according to the size of the vitiligo patches. Participants will be assessed at the start and after 12 weeks of treatment using the Vitiligo Area Scoring Index (VASI) to measure repigmentation. A blinded medical observer will evaluate pigment return and side effects like skin irritation or scarring. Patient satisfaction will also be recorded. Overall safety and efficacy will be monitored throughout the study, which lasts up to 6 months from enrollment to treatment completion.
CONDITIONS
Brief Title
Effectiveness of Micro-needling With 5 Fluorouracil Versus Potent Topical Steroids in the Treatment of Limited Vitiligo
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willingness to participate in the study
- Age between 5 and 70 years
- Vitiligo affecting less than or equal to 10% of body surface area
You will not qualify if you...
- Current or recent use of other treatments for vitiligo
- Pregnant or breastfeeding women
- Unstable vitiligo
- Use of immunosuppressant medications for other diseases
- Having anemia, immunosuppression, bleeding disorder, taking anticoagulants or anti-platelet drugs, or epilepsy
- History of keloids or hypertrophic scars
- Known allergy to either of the study drugs
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants receive either micro-needling with 5-fluorouracil every 2 weeks or apply topical 0.05% clobetasol propionate ointment twice daily to treat limited vitiligo.
6 treatment sessions every 2 weeks for micro-needling group or daily topical application for 12 weeks for steroid group
Duration - 1 visit at end of 12 weeks
An independent observer performs clinical assessments to evaluate re-pigmentation and side effects after treatment completion.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
CMH Bahawalpur
Chak Four Hundred Fifty-four, Pakistan
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here