"5-Fluorouracil vs. calcipotriol-betamethasone with microneedling in vitiligo

Evaluation of the effectiveness of 5-fluorouracil compared to calcipotriol and betamethasone with microneedling in vitiligo patients

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20160523028008N35

Enrollment

Registered

2025-10-04

Start date

2025-09-23

Completion date

Unknown

Last updated

2025-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vitiligo. Vitiligo

Interventions

Intervention 1: Intervention Group 1: Microneedling (Dermapen device, 36-pin cartridge, Dr.Pen model A6, depth 0.5–1 mm until pinpoint bleeding) with topical 5% fluorouracil cream (chemical formula: C

Eligibility

Sex/Gender

All

Age

10 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients with stable vitiligo and no new lesions for six months Willingness to provide informed consent for participation in the study

Exclusion criteria

Exclusion criteria: Pregnant women Breastfeeding mothers Patients with facial, genital, or intertriginous lesions Active Koebner phenomenon Coagulation disorders Hypersensitivity to medication

Design outcomes

Primary

Measure	Time frame
Vitiligo Area Scoring Index score. Timepoint: Study outcomes are assessed at four time points: 1) before the start of the intervention (baseline), 2) 4 weeks after the start of the intervention, 3) 8 weeks after the start of the intervention, and 4) 12 weeks after the start of the intervention (end of the intervention period). Method of measurement: For the observation and recording of study outcomes, the Vitiligo Area Scoring Index (VASI) is used as the dedicated tool.	—

Measure

Time frame

Vitiligo Area Scoring Index score. Timepoint: Study outcomes are assessed at four time points: 1) before the start of the intervention (baseline), 2) 4 weeks after the start of the intervention, 3) 8 weeks after the start of the intervention, and 4) 12 weeks after the start of the intervention (end of the intervention period). Method of measurement: For the observation and recording of study outcomes, the Vitiligo Area Scoring Index (VASI) is used as the dedicated tool.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactRoya Mohammad Bygi

Hamedan University of Medical Sciences

royamohammadbygi@gmail.com+98 902 595 7977

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026