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NCT Number: NCT07837908

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of medicine, Al-Azhar University Assuit

Asyut, Asyut Governorate, 71511, Egypt

About this study

'Non-vitiligo leukoderma represents a heterogeneous group of acquired hypopigmentary disorders that may occur following burns, inflammatory dermatoses, trauma, or other cutaneous insults. Treatment can be challenging because of altered skin architecture, scar formation, and impaired melanocyte function or availability.

This randomized controlled prospective single-blinded comparative clinical study will include 16 patients with acquired non-vitiligo leukoderma recruited from the outpatient clinic of Al-Azhar University Hospital (Assiut). Eligible lesions will be treated using either fractional carbon dioxide (CO2) laser therapy followed by topical 5-fluorouracil or mechanical dermabrasion followed by topical 5-fluorouracil. Random allocation will be performed using a computer-generated random allocation sequence.

Fractional CO2 laser sessions will be performed at 4-6-week intervals, with a total of 3-4 sessions. Mechanical dermabrasion will be performed until pinpoint bleeding appears, followed immediately by topical 5-fluorouracil application, with a total of 3-4 sessions. Similar post-procedure care will be provided.

Treatment outcomes will be assessed using objective and subjective measures, including the Vancouver Scar Scale, Vitiligo Analysis by Computer Assisted Grid (VACAG), assessment of treatment-related adverse effects, physician assessment of clinical improvement using the Mean Improvement Score by Physician (MISP), standardized clinical photography, and patient satisfaction using a 10-point visual analogue scale. Adverse effects such as infection, scarring, Koebner phenomenon, aggravation of depigmentation, pain, burning sensation, erythema, and edema will be documented.

The study will be conducted after approval by the local Ethics Committee of the Faculty of Medicine, Al-Azhar University, Assiut. Written and verbal informed consent will be obtained from participating patients, and privacy of the collected data will be maintained.'

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

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.

Primary outcomes

  1. Degree of Repigmentation

    Time frame: 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.

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Registry information

Official study title

Fractional Co2 Laser vs Dermabrasion 5-Flurouracil Delivery in Acquired Leukoderma: A Comparative Study

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 24, 2026
Registry last updated
Sep 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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