Safety And Efficacy Of Topical Prostaglandin F2α Analogs In Combination With Fractional CO2 Laser And 308 Excimer Light In Treatment Of Vitiligo
试验速览
- 阶段
- 4 期
- 入组人数
- 30
- 主要终点
- clinical improvement through VASI score
研究概览
简要总结
Vitiligo is a chronic disease with an unpredictable clinical course, characterized by the appearance of white macules and patches on the skin and mucous membranes due to the disappearance of melanocytes in the affected area.
It affects approximately 0.5% - 2% of the population worldwide and may occur at any age.
Vitiligo is caused by a dynamic interplay between genetic and environmental risks that initiates an autoimmune attack on melanocytes in the skin.
详细描述
The treatment of vitiligo has been a challenge for dermatologists. Recent reports have highlighted darkening of iris, and eyelashes and periocular hyperpigmentation induced by prostaglandin F2α analogues used for the treatment of glaucoma (as travoprost). Extrapolating these findings in the treatment of vitiligo.
The beneficial effect of fractional CO2 laser on vitiligo is postulated to come from the release of cytokines and growth factors that act as mitogens for melanogenesis . The preceding laser also alters the skin barrier, which results in increased penetration of topical drugs and ultraviolet (UV) radiation.
308 nm excimer laser is a monochromatic, target type treatment and allows the delivery of higher fluences to the lesions and avoids damage to the surrounding normal skin resulting in a faster and more effective pigmentation with minimal side effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
no masking
入排标准
- 年龄范围
- 12 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients older than 12 years.
- •Patients with generalized non-segmental vitiligo.
- •No previous treatment for vitiligo in the last 1 month.
- •Patients who were unresponsive to medical treatment or photo therapy for at least 3 months.
排除标准
- •Patients with sensitivity to travoprost.
- •Patients with photosensitivity.
- •Patients with history or active skin cancer.
- •No other dermatological or systemic diseases.
- •Active infections .
- •Pregnant or lactating females.
研究组 & 干预措施
vitiligo patients
Thirty Patients complaining of generalized non segmental vitiligo will be recruited in this study. They will be chosen from the attendants of the out-patient clinics of Dermatology, Assiut university hospital. six patches will be selected in each patient.
干预措施: Topical travoprost 0.004% solution (Drug)
vitiligo patients
Thirty Patients complaining of generalized non segmental vitiligo will be recruited in this study. They will be chosen from the attendants of the out-patient clinics of Dermatology, Assiut university hospital. six patches will be selected in each patient.
干预措施: Fractional CO2 laser (Device)
vitiligo patients
Thirty Patients complaining of generalized non segmental vitiligo will be recruited in this study. They will be chosen from the attendants of the out-patient clinics of Dermatology, Assiut university hospital. six patches will be selected in each patient.
干预措施: Excimer laser (Device)
vitiligo patients
Thirty Patients complaining of generalized non segmental vitiligo will be recruited in this study. They will be chosen from the attendants of the out-patient clinics of Dermatology, Assiut university hospital. six patches will be selected in each patient.
干预措施: Combination therapy (Other)
vitiligo patients
Thirty Patients complaining of generalized non segmental vitiligo will be recruited in this study. They will be chosen from the attendants of the out-patient clinics of Dermatology, Assiut university hospital. six patches will be selected in each patient.
干预措施: Excimer laser and travoprost (Other)
vitiligo patients
Thirty Patients complaining of generalized non segmental vitiligo will be recruited in this study. They will be chosen from the attendants of the out-patient clinics of Dermatology, Assiut university hospital. six patches will be selected in each patient.
干预措施: fractional CO2 laser and topical travoprost (Other)
结局指标
主要结局
clinical improvement through VASI score
时间窗: 9 months
VASI score will be calculated for each patient at start, every 4 weeks and 6 months after the last session. VASI = ∑ all treated sites \[number of hand units\] X \[% residual depigmentation\].
次要结局
- Patients satisfaction(9 months)
- percent of repigmentation(9 months)
- Histopathological evaluation(9 months)
研究者
GAbdelsamea
principle investigator
Assiut University