Fractional CO2 Laser vs Dermabrasion With 5-Fluorouracil for Acquired Leukoderma
Fractional Co2 Laser vs Dermabrasion 5-Flurouracil Delivery in Acquired Leukoderma: A Comparative Study
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
'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.'
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Walaa Ashraf Sayed
- Numéro de téléphone: MBBS
- E-mail: walaaashraf464@yahoo.com
Lieux d'étude
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Asyut Governorate
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Asyut, Asyut Governorate, Egypte, 71511
- Faculty of medicine, Al-Azhar University Assuit
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Fractional CO2 Laser + 5-Fluorouracil
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. |
Fractional carbon dioxide (CO2) laser therapy followed by topical 5-fluorouracil application. Laser parameters will be adjusted according to lesion size and site. Topical 5-fluorouracil applied immediately after fractional CO2 laser or dermabrasion according to the assigned study arm. |
|
Comparateur actif: Dermabrasion + 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. � |
Topical 5-fluorouracil applied immediately after fractional CO2 laser or dermabrasion according to the assigned study arm. Mechanical dermabrasion using manual or motor-driven dermabrasion followed immediately by topical 5-fluorouracil application. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Degree of Repigmentation
Délai: 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. |
At baseline and 6 months after treatment
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Maladies de la peau
- Troubles pigmentaires
- Maladies de la peau et du tissu conjonctif
- Vitiligo
- Hypopigmentation
- Composés hétérocycliques, 1 anneau
- Composés hétérocycliques
- Thérapeutique
- Procédures chirurgicales, opératoires
- Pyrimidines
- Uracile
- Pyrimidinones
- Procédures de chirurgie plastique
- Techniques cosmétiques
- Procédures chirurgicales dermatologiques
- Fluorouracile
- Dermabrasion
Autres numéros d'identification d'étude
- MSC/AZ.AST./DVA021/9/245/4/26
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
Individual participant data will not be shared with other researchers.
Informations sur les médicaments et les dispositifs, documents d'étude
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