Bimatoprost 0.03% Solution, NB-UVB and Fractional Carbon Dioxide Laser in Treatment of Generalized Vitiligo
试验速览
- 阶段
- 4 期
- 入组人数
- 40
- 主要终点
- Frequency and types of side effects
研究概览
简要总结
Vitiligo is a chronic disorder of pigmentation characterized by the development of white macules on the skin due to loss of epidermal melanocytes. It affects approximately 0.5%-2% of general population world-wide, without predilection for sex or race.Vitiligo can be classified into segmental or non-segmental. Non-segmental or generalized vitiligo is the most common clinical presentation and often involves the face and acral regions.
Multiple monotherapy modalities are established to treat vitiligo but the response is variable, unsatisfactory, and requiring a prolonged course. This problem is exaggerated by the multifactorial and polygenic nature of the pathomechanism of the disease. These facts pave the way to combination therapy that showed better and safe repigmentation response than monotherapy.
详细描述
Bimatoprost 0.03% ophthalmic solution is a synthetic prostaglandin F2 alpha analog that is approved for the treatment of glaucoma and eyelashes hypotrichosis (Lee et al, 2017). Cutaneous hyperpigmentation of the treated sites has been reported as a side effect with this agent. Phototherapy (narrow band ultraviolet B (NB-UVB)) of wavelength 308 nm, is considered as a successful method of treatment of vitiligo. The cytotoxic T-cells accountable for the destruction of melanocytes and disappearance of melanin are eliminated by phototherapy through apoptosis (diffuse repigmentation) and UVB does stimulate melanocytic proliferation and their migration to the epidermis from nearby follicular units (follicular repigmentation) and perilesional active melanocytes (marginal repigmentation).
In recent years, fractional carbon dioxide laser has been introduced as an add-on treatment for vitiligo. It represents a new modality for skin resurfacing based on the theory of fractional photothermolysis. The beneficial effect of fractional carbon dioxide laser on vitiligo is the release of cytokines and growth factors that act as mitogens for melanogenesis. It also alters the skin barrier, which results in increased penetration of topical drugs and ultraviolet (UV) radiation, so it can be used in combination therapy.
研究设计
- 研究类型
- Interventional
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients older than
- •Patients with non-segmental vitiligo.
- •Lesions stable for at least one year.
- •Patients who were unresponsive to medical treatment or photo therapy for at least 3 months.
- •No sex or site predilection.
- •Bilateral and symmetrical lesions with maximum size of 10×10 cm.
排除标准
- •Patients with active infection.
- •Patients with sensitivity to bimatoprost or photosensitivity.
- •Patients with history or active skin cancer.
- •Pregnant or lactating females.
研究组 & 干预措施
Generalized vitiligo patients
Each patient with generalized vitiligo will be subjected to the following:
One side will be treated by narrow band ultraviolet rays sessions twice weekly for 3 months + topical bimatoprost 0.03% ophthalmic solution solution twice daily ( 1 drop for each 2 cm2 ) and the other side will be treated by topical bimatoprost 0.03% ophthalmic solution twice daily ( 1 drop for each 2 cm2 ) + narrow band ultraviolet rays sessions twice weekly for 3 months + 10.600-nm fractional carbon dioxide laser sessions twice monthly for 3 months.
干预措施: Bimatoprost 0.03% ophthalmic solution (Drug)
结局指标
主要结局
Frequency and types of side effects
时间窗: 3 months
Frequency and types of side effects.
Repigmentation of skin lesions
时间窗: 3 months
Patients will be followed up by two blind dermatologists after 3 months to detect: The percent of repigmentation: that will be subjectively rated with a previously reported scoring system: * \< 25% repigmentation (poor). * 25-50% repigmentation (fair). * 50-75% repigmentation (good). -\> 75% repigmentation (excellent).
次要结局
- Vitiligo area scoring index score(3 months)
- Patient satisfaction(6 months)
研究者
Aml Hassan Ali
Principle investigator
Assiut University