An interventional study of Fractional CO2 Laser and Dermabrasion in Leukoderma and Hypopigmentation, sponsored by Al-Azhar University. Not yet recruiting at 1 site in Egypt. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-24.
Sponsored by Al-Azhar University · Not applicable, Interventional, and Treatment
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.
'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.'
343 studies on the registry are indexed under Vitiligo; 96 are open to participants now.
This study's planned enrollment of 16 is below the median of 36 across 265 interventional studies indexed under Vitiligo.
Browse Vitiligo studies →Al-Azhar University is the lead sponsor of 531 studies on the registry; 172 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
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Washout period
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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
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
Fractional carbon dioxide (CO2) laser therapy followed by topical 5-fluorouracil application. Laser parameters will be adjusted according to lesion size and site.
Mechanical dermabrasion using manual or motor-driven dermabrasion followed immediately by topical 5-fluorouracil application.
Topical 5-fluorouracil applied immediately after fractional CO2 laser or dermabrasion according to the assigned study arm.
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
Plan to share: No — Individual participant data will not be shared with other researchers.
No publications or documents are linked to this record.
Start is estimated for Aug 2026; primary completion for Jul 2027, 11 months later.
Of 63 non-industry interventional studies with no phase under Vitiligo, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 33. This study's planned 11 months is below that.
Counting every sponsor, half of 67 studies reached it within 17 months; a quarter within 8 and three quarters within 32.
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This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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