Comparison of the Effectiveness Between a Combination of 0.005% Latanoprost Gel With 308 nm Excimer Phototherapy and a Combination of 0.1% Mometasone Furoate Cream With 308 nm Excimer Phototherapy on Repigmentation of Nonsegmental Vitiligo in Children
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Area of repigmentation
研究概览
简要总结
Latanoprost, a prostaglandin F2α (PGF2α) analog used for glaucoma treatment, is known to cause iris darkening, hypertrichosis, and periocular skin hyperpigmentation. PGF2α has been shown to stimulate the growth of melanocyte dendrites, increasing dendricity even at low doses, as well as enhancing tyrosinase activity and quantity, thereby promoting repigmentation. Studies on the use of 0.005% latanoprost gel in both children and adults with vitiligo have demonstrated effective repigmentation without reported side effects.
详细描述
Vitiligo is an acquired pigmentation disorder caused by the progressive loss of melanocytes in the epidermal layer of the skin and/or mucosa, characterized by macules or patches of depigmentation. Vitiligo can occur at any age, including in childhood. Treatment options for vitiligo include medical therapies (topical, systemic, and radiation) as well as surgical approaches. A combination of topical corticosteroids and phototherapy has shown fairly good repigmentation success in treating vitiligo in children. However, long-term use can lead to side effects such as skin atrophy, striae, telangiectasia, hypopigmentation, acneiform eruptions, and hypertrichosis. Latanoprost, a prostaglandin F2α (PGF2α) analog used for glaucoma treatment, is known to cause iris darkening, hypertrichosis, and periocular skin hyperpigmentation. Because of these effects, it has been studied as a treatment for alopecia and hypopigmentation disorders. PGF2α has been shown to stimulate the growth of melanocyte dendrites, increasing dendricity even at low doses, as well as enhancing tyrosinase activity and quantity, thereby promoting repigmentation. Studies on the use of 0.005% latanoprost gel in both children and adults with vitiligo have demonstrated effective repigmentation without reported side effects. To date, there have been no published studies in Indonesia investigating the use of 0.005% topical latanoprost gel for the repigmentation of stable vitiligo lesions in children. Therefore, research comparing the effectiveness of latanoprost gel and 0.1% mometasone furoate cream in combination with phototherapy-the mainstay treatment for pediatric vitiligo in Indonesia-is necessary.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 10 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with non-segmental vitiligo.
- •Patients with stable vitiligo for at least 6 months based on the Vitiligo Disease Activity (VIDA) score.
- •Aged 10-17 years.
- •Affected area <10%.
- •Having at least two lesions to be treated. The vitiligo lesions selected for treatment must meet the following criteria:
- •Relatively the same size, ranging from a minimum of 1 cm² to 4 cm².
- •Bilateral location on both sides of the body.
- •A minimum distance of 5 cm between the studied lesions and other vitiligo lesions.
- •Not located on the palms, soles, or genital area.
排除标准
- •Use of topical therapy (corticosteroids, calcineurin inhibitors, psoralen, and antioxidants) for at least 2 weeks before the study, systemic therapy (corticosteroids, antioxidants, and vitamin D) for at least 4 weeks before the study, and phototherapy for at least 4 weeks before the study.
- •Presence of other active autoimmune diseases such as type 1 diabetes mellitus, thyroid disease, alopecia areata, rheumatoid arthritis, or Addison's disease, based on medical history and physical examination.
- •History of or current skin cancer, photosensitivity, or undergoing radiotherapy.
- •Allergy or contraindication to topical corticosteroids or latanoprost.
- •History of hypertension, asthma, diabetes mellitus, anemia, kidney, liver, neurological, or cardiovascular diseases.
研究组 & 干预措施
Group A: 0.005% latanoprost gel and 308 nm excimer phototherapy
- Apply 0.005% latanoprost gel to the predetermined skin lesions twice daily (morning and evening) every day for 12 weeks.
- Phototherapy is administered at a dose based on the lesion's location and the response to previous phototherapy sessions. Phototherapy is performed twice a week for 12 weeks.
干预措施: 0.005% latanoprost gel (Drug)
Group B : 0.1% mometasone furoate cream and 308 nm excimer phototherapy
- Apply 0.1% mometasone furoate cream to the predetermined skin lesions twice daily (morning and evening) for 12 weeks.
- Phototherapy is administered at a dose based on the lesion's location and the response to previous phototherapy sessions. Phototherapy is performed twice a week for 12 weeks.
干预措施: 0.1% mometasone furoate cream (Drug)
结局指标
主要结局
Area of repigmentation
时间窗: From enrollment to the end of treatment at 12 weeks
The percentage level of repigmentation area in lesions before and after therapy. Evaluated by Software ImageJ on the week 2, week 4, week 6, week 8, week 10, week 12. The assessment categories are as follows: Poor for less than 50%, Fair for 50 to 74%, Good for 75 to 89%, and Excellent for 90 to 100%. These percentage ranges help classify the level of achievement or effectiveness in the evaluation.
Pattern of repigmentation
时间窗: From enrollment to the end of treatment at 12 weeks
The pattern of skin color return, such as perifolicular, diffuse, marginal or mixed. Evaluated by dermoscopy on the week 2, week 4, week 6, week 8, week 10, week 12.
Number of lesions with repigmentation
时间窗: From enrollment to the end of treatment at 12 weeks
The initial appearance of repigmentation on VNS lesions after treatment. Evaluated by dermoscopy on the week 2, week 4, week 6, week 8, week 10, week 12.
次要结局
- VASI score assessment(From enrollment to the end of treatment at 12 weeks)
- Side effects and subjective complaints(From enrollment to the end of treatment at 12 weeks)