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

NCT07837908 · tracked via the Priya Life Science Egypt tracker
Phase
Not applicable
Started
2026-08-26
Last updated
2026-09-24

Condition(s) studied

LeukodermaHypopigmentation

Investigational drug(s) / intervention(s)

Fractional CO2 LaserDermabrasion5-Fluorouracil →

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

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

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

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Primary outcome measure(s)

  • Degree of Repigmentation — At baseline and 6 months after treatment
    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.

Trial sites (1)

FacilityCityRegionStatus
Faculty of medicine, Al-Azhar University Assuit Asyut Asyut Governorate
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07837908 on ClinicalTrials.gov ↗ ← All trials in Egypt