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

NCT07398807 | Recruiting Early Phase 1

• 1 other identifier: 1516/EC/14/2025
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Vitiligo

Keywords

Vitiligo; Limited; Microneedling; 5-FU

Outcome Measures

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.

  From enrollment to the end of treatment at 6 months

Study Arms (2)

Microneedling with topical 5-fluorouracil

EXPERIMENTAL

Drug: Microneedling with 5-fluorouracil

Clobetasol propionate 0.05%

ACTIVE COMPARATOR

Drug: Topical application of 0.05% Clobetasol propionate

Interventions

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.

Microneedling with topical 5-fluorouracil

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.

Clobetasol propionate 0.05%

Eligibility Criteria

• Age: 4 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Combined Military Hospital (CMH) institute of Medical Sciences Bahawalpur Pakistan: lead

Study Sites (1)

CMH Bahawalpur

Chak Four Hundred Fifty-four, Pakistan

RECRUITING

MeSH Terms

Conditions

Vitiligo

Interventions

Percutaneous Collagen Induction; Fluorouracil; Clobetasol

Condition Hierarchy (Ancestors)

Hypopigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Punctures; Rehabilitation; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Betamethasone; Steroids, Fluorinated; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: November 15, 2025
• First Posted: February 10, 2026
• Study Start: August 8, 2025
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: February 17, 2026

Record last verified: 2026-02

Locations

PA (1)