NCT07775105

Brief Summary

This randomized, single-blinded clinical trial evaluates the efficacy and safety of topical pentoxifylline compared with topical 5-fluorouracil, both combined with microneedling and narrow-band ultraviolet B (NB-UVB) phototherapy, in patients with stable vitiligo. A total of 42 patients with stable vitiligo received six biweekly microneedling sessions over three months, with concomitant NB-UVB phototherapy twice weekly, followed by a three-month follow-up period. Each patient had three vitiliginous patches allocated to topical pentoxifylline with microneedling, topical 5-fluorouracil with microneedling, or microneedling alone.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2023

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 4, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

August 15, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 20, 2026

Completed
Last Updated

August 20, 2026

Status Verified

August 1, 2026

Enrollment Period

2.3 years

First QC Date

August 15, 2026

Last Update Submit

August 15, 2026

Conditions

Vitiligo VulgarisMicroneedling-Assisted DeliveryPhototherapy

Keywords

vitiligomicroneedlingNarrow band phototherapy5-flurouracilPentoxiphylline

Outcome Measures

Primary Outcomes (1)

  • Physician Global Aesthetic Improvement Scale (GAIS) score

    Physician-assessed percentage of repigmentation of treated vitiligo lesions using the GAIS.

    After 6 treatment sessions (3 months)

Study Arms (3)

Microneedling + topical treatment (PTX 20 mg/ml)

ACTIVE COMPARATOR

Microneedling + topical treatment (PTX 20 mg/ml) followed by phototherapy

Combination Product: Microneedling + topical treatment (PTX 20 mg/ml) followed by NB phototherapy

Microneedling + topical treatment (5-FU 5%)

ACTIVE COMPARATOR

Microneedling + topical treatment (5-FU 5%)+phototherapy

Combination Product: Microneedling + topical treatment (5-FU 5%) followed by NB phototherapy

Microneedling alone

PLACEBO COMPARATOR

Microneedling alone+phototherapy

Procedure: Microneedling alone followed by NB phototherapy

Interventions

Microneedling + topical treatment (PTX 20 mg/ml) followed by NB phototherapyCOMBINATION_PRODUCT

Microneedling + topical treatment (PTX 20 mg/ml) followed by NB phototherapy

Microneedling + topical treatment (PTX 20 mg/ml)
Microneedling + topical treatment (5-FU 5%) followed by NB phototherapyCOMBINATION_PRODUCT

Microneedling + topical treatment (5-FU 5%) followed by NB phototherapy

Microneedling + topical treatment (5-FU 5%)
Microneedling alone followed by NB phototherapyPROCEDURE

Microneedling alone followed by NB phototherapy

Microneedling alone

Eligibility Criteria

Age6 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Patients with stable vitiligo. No new or progressive vitiligo lesions for at least 1 year. No vitiligo treatment for at least 3 months. Age 6-55 years based on the enrolled study population

You may not qualify if:

  • History of keloidal tendency. Bleeding tendency. Current anticoagulant therapy. Pregnancy or breastfeeding. Presence of other systemic or dermatological diseases. Contraindications to phototherapy. Photosensitive disorders, including lupus erythematosus or xeroderma pigmentosum.
  • Personal or family history of skin cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tanta University Hospitals

Tanta, Egypt

Location

MeSH Terms

Conditions

Vitiligo

Interventions

Percutaneous Collagen InductionTherapeuticsFluorouracil

Condition Hierarchy (Ancestors)

HypopigmentationPigmentation DisordersSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Complementary TherapiesPhysical Therapy ModalitiesPuncturesRehabilitationUracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

August 15, 2026

First Posted

August 20, 2026

Study Start

January 1, 2023

Primary Completion

April 4, 2025

Study Completion

June 30, 2025

Last Updated

August 20, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)