Fractional CO2 Laser vs Dermabrasion With 5-Fluorouracil for Acquired Leukoderma

NCT07837908 | Not Yet Recruiting

• 1 other identifier: MSC/AZ.AST./DVA021/9/245/4/26
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized controlled prospective single-blinded comparative clinical study aims to compare the efficacy and safety of fractional carbon dioxide (CO2) laser therapy versus mechanical dermabrasion, both combined with topical 5-fluorouracil, in the treatment of acquired non-vitiligo leukoderma. The study will evaluate repigmentation, clinical improvement, patient satisfaction, and treatment-related adverse effects.

Conditions

Leukoderma; Hypopigmentation

Outcome Measures

Primary Outcomes (1)

• Degree of Repigmentation

  Repigmentation will be assessed by two blinded dermatologists using the Mean Improvement Score by Physician (MISP), based on a 5-grade scale: grade 1, \<25% improvement; grade 2, 25-49%; grade 3, 50-74%; grade 4, \>75-99%; and grade 5, 100% complete repigmentation.

  At baseline and 6 months after treatment

Study Arms (2)

Fractional CO2 Laser + 5-Fluorouracil

EXPERIMENTAL

Patients will receive fractional carbon dioxide (CO2) laser therapy followed by topical 5-fluorouracil. Laser parameters will be adjusted according to the site and size of the lesions. Treatment sessions will be performed at 4-6-week intervals for a total of 3-4 sessions. Post-procedure care will include topical antibiotic ointment and emollients.

Device: Fractional CO2 Laser; Drug: 5-Fluorouracil

Dermabrasion + 5-Fluorouracil

ACTIVE COMPARATOR

Patients will undergo mechanical dermabrasion using manual or motor-driven dermabrasion until the appearance of pinpoint bleeding, followed immediately by topical 5-fluorouracil application. A total of 3-4 sessions will be performed. Similar post-procedure care will be provided. �

Procedure: Dermabrasion; Drug: 5-Fluorouracil

Interventions

Fractional CO2 Laser DEVICE

Fractional carbon dioxide (CO2) laser therapy followed by topical 5-fluorouracil application. Laser parameters will be adjusted according to lesion size and site.

Fractional CO2 Laser + 5-Fluorouracil

Dermabrasion PROCEDURE

Mechanical dermabrasion using manual or motor-driven dermabrasion followed immediately by topical 5-fluorouracil application.

Dermabrasion + 5-Fluorouracil

5-Fluorouracil DRUG

Topical 5-fluorouracil applied immediately after fractional CO2 laser or dermabrasion according to the assigned study arm.

Dermabrasion + 5-Fluorouracil; Fractional CO2 Laser + 5-Fluorouracil

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients receiving topical treatment will be required to undergo a two-week washout period.
• No sex predilection.
• Cooperative patients.
• Patients with non-vitiligo leukoderma, including post-burn leukoderma, post-inflammatory hypopigmentation, and stable hypopigmented scar.

You may not qualify if:

• Vitiligo leukoderma.
• History of bleeding disorder or current anticoagulant therapy.
• Pregnancy or lactation.
• Keloid scarring or hypertrophic scars.
• Unrealistic expectations.
• Laser therapy within one month prior to enrollment.
• Koebnerization.
• Photosensitivity.
• Seizure disorders.
• Active dermatosis or active bacterial, viral, or fungal cutaneous infection within the treatment area.

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (1)

Faculty of medicine, Al-Azhar University Assuit

Asyut, Asyut Governorate, 71511, Egypt

Location

MeSH Terms

Conditions

Vitiligo; Hypopigmentation

Interventions

Dermabrasion; Fluorouracil

Condition Hierarchy (Ancestors)

Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Cosmetic Techniques; Therapeutics; Dermatologic Surgical Procedures; Plastic Surgery Procedures; Surgical Procedures, Operative; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Walaa Ashraf Sayed

CONTACT

MBBS; walaaashraf464@yahoo.com

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: Resident

Study Record Dates

• First Submitted: September 9, 2026
• First Posted: September 24, 2026
• Study Start: August 26, 2026
• Primary Completion (Estimated): July 26, 2027
• Study Completion (Estimated): August 26, 2027
• Last Updated: September 24, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)