Fractional Co2 Laser vs Dermabrasion 5-Flurouracil Delivery in Acquired Leukoderma: A Comparative Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Degree of Repigmentation
研究概览
简要总结
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.
详细描述
'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.'
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Fractional CO2 Laser (Device)
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. �
干预措施: Dermabrasion (Procedure)
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.
干预措施: 5-Fluorouracil (Drug)
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. �
干预措施: 5-Fluorouracil (Drug)
结局指标
主要结局
Degree of Repigmentation
时间窗: 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.
次要结局
未报告次要终点
研究者
Walaa Ashraf Sayed
Resident
Al-Azhar University