Effectiveness of Micro-needling With 5 Fluorouracil Versus Potent Topical Steroids in the Treatment of Limited Vitiligo

ConditionVitiligo
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age4-70
SponsorCombined Military Hospital (CMH) institute of Medical Sciences Bahawalpur Pakistan

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Microneedling with 5-fluorouracil

    Drug

    Micro-needling will be done, 2 passes will be made on the affected patch of vitiligo with 5 FU. Not more than 0.5 ml 5FU will be used during each session. Session will be repeated 2 weekly for 6 months.

  • Topical application of 0.05% Clobetasol propionate

    Drug

    Topical 0.05% clobetasol propionate ointment will be applied twice a day on the vitiligo patches.1 finger-tip unit (FTU) will be used for 2% BSA i.e., 0.5 grams.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Microneedling with topical 5-fluorouracilExperimental treatment 1 intervention
Group B: Clobetasol propionate 0.05%Active comparator 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame
From enrollment to the end of treatment at 6 months

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.