Fractional CO2 Laser facilitated delivery of topical immunomodulators for treatment of localized vitiligo - Ruxolitinib versus Tacrolimus: A Randomized, Intraindividual Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 10
- 试验地点
- 1
研究概览
简要总结
Vitiligo is a chronic autoimmune dermatological disorder characterized by the selective destruction of melanocytes, resulting in depigmented macules and patches on the skin and mucous membranes. The pathogenesis involves a complex interplay of genetic susceptibility, environmental triggers, oxidative stress, and immune-mediated mechanisms, including T-cell infiltration and cytokine dysregulation, particularly involving the JAK-STAT pathway.This leads to progressive loss of pigmentation, often with a significant psychosocial impact due to aesthetic concerns and associated stigma.
Vitiligo is classified into several types based on clinical presentation. Non-segmental vitiligo (NSV), the most common form, is bilateral and symmetrical, encompassing subtypes such as generalized, acrofacial, and universal vitiligo. Segmental vitiligo, in contrast, is unilateral and follows a dermatomal distribution, often stabilizing early. Other variants include focal and mucosal types, with the disease categorized by activity as stable (no progression for at least one year) or active/progressive.
Epidemiologically, vitiligo affects approximately 0.5-1% of the global population, with prevalence varying regionally. A 2024 meta-analysis estimated a pooled prevalence of 0.5% among adults, with higher rates in South Asia, including India, where genetic and environmental factors may contribute to a prevalence of up to 2-3%.Incidence rates range from 0.2-0.4 per 1,000 person-years, with onset typically between 10-30 years.
Current treatment options aim to stabilize disease progression and promote repigmentation. Medical therapies include topical corticosteroids, calcineurin inhibitors (e.g., tacrolimus 0.1%), and JAK inhibitors (e.g., ruxolitinib 1.5% cream), with the latter showing efficacy in NSV through phase III trials.Phototherapies like narrowband UVB (NB-UVB) and excimer laser (308 nm) are effective for widespread cases, achieving 50-75% repigmentation.Surgical options, such as autologous grafting, are reserved for stable vitiligo, yielding over 70% repigmentation.
Due to variable response to monotherapy, combination therapies are increasingly utilized. Common regimens include NB-UVB with tacrolimus or ruxolitinib, enhancing repigmentation through synergistic effects.[9][6] Fractional CO2 laser-assisted drug delivery (LADD) with phototherapy improves topical penetration, showing promise in resistant cases.
This study investigates the comparative efficacy of CO2 laser-assisted delivery of tacrolimus versus ruxolitinib, both combined with excimer laser, to optimize treatment for recalcitrant vitiligo in a diverse population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 12.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients 12 to 60 years of age having at least two comparable or symmetric or lesions suitable for intraindividual comparison vitiligo lesions.
- •Patients with localized vitiligo less than10% body surface area.
- •Stable vitiligo for at least 6 months prior to enrolment, defined by no new lesions or expansion of existing lesions.
- •Vitiligo Disease Activity score of 0–1, indicating stable or minimally active disease.
- •Patients who have not been on any biologic drug for 12 weeks, no phototherapy within 8 weeks, no immunomodulating treatment within 4 weeks and no topical treatments within 1 week.
- •Willingness to comply with study procedures and avoid other vitiligo treatments during the trial.
排除标准
- •Active or progressive vitiligo (VIDA score greater 1).
- •History of hypersensitivity to tacrolimus, laser therapy or excimer light.
- •Concomitant skin conditions (e.g., psoriasis, eczema) that could interfere with assessments.
- •Systemic immunosuppressive therapy within 4 weeks or topical treatments (including JAK inhibitor) within 4 weeks prior to enrolment.
- •Comorbidities such as active infection, malignancy, history of thromboembolic episodes, past or present smoker or severe hepatic/renal impairment.
- •Pregnancy, lactation or inadequate contraception in women of childbearing potential.
研究者
Dr Madura C
CUTIS Academy of Cutaneous Sciences