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

ConditionsLeukoderma Hypopigmentation

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-75

SponsorAl-Azhar University

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Vitiligo leukoderma.

History of bleeding disorder or current anticoagulant therapy.

Pregnancy or lactation.

Keloid scarring or hypertrophic scars.

Trial design

Design model

Parallel

Treatments tested in this trial

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.
Dermabrasion
Procedure/Surgery
Mechanical dermabrasion using manual or motor-driven dermabrasion followed immediately by topical 5-fluorouracil application.
5-Fluorouracil
Drug
Topical 5-fluorouracil applied immediately after fractional CO2 laser or dermabrasion according to the assigned study arm.

Treatment groups

16 Participants

are divided into 2 treatment groups

Group A: Fractional CO2 Laser + 5-FluorouracilExperimental treatment 2 interventions

Group B: Dermabrasion + 5-FluorouracilActive comparator 2 interventions

Trial outcomes

Primary outcomes

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.

Time frame

At baseline and 6 months after treatment

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Al-Azhar University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: