A split-body study to compare the efficacy of combination of CO2 laser and topical methotrexate 1% versus CO2 laser and 5-fluorouracil 5% in stable acral vitiligo.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Proportion of patients achieving 50% reduction in lesional vitiligo area & severity index (VASI) from baseline at five months.
研究概览
简要总结
Vitiligo is a common acquired, depigmenting skin disease that affect the patient’s psychological state and quality of life. Acral vitiligo is often refractory to treatment as compared to vitiligo at non-acral sites. Several modalities are available for treating acral vitiligo, but none are completely satisfactory. Recently, fractional carbon dioxide (CO2) laser has been introduced as an add-on treatment for vitiligo. Fractional CO2 laser acts by stimulating the release of cytokines and growth factors that act as mitogens for melanogenesis. Also, microscopic ablative zones produced by it promotes the trans-epidermal penetration of topical agents, providing additional benefits for repigmentation. Ablative fractional laser-assisted delivery of topical 5-fluorouracil (5-FU) has been used in vitiligo in several studies with good results, and the combination of CO2 laser and 5-FU has been recommended for the treatment of acral vitiligo by the British Association of Dermatologists Guidelines.1 Recently, topical methotrexate 1% gel was used in a case report of vitiligo and was applied to a single patch twice daily for 12 weeks with significant improvement in pigmentation without local or systemic side effects during the course of therapy. Thus, it may prove to be an important steroid-sparing agent in the treatment of vitiligo. As methotrexate is a large, hydrophilic molecule that does not penetrate intact skin, several drug delivery systems are being developed such as, nano-vehicle preparations and laser-assisted delivery. One study has evaluated fractional Erbium laser-assisted delivery of topical methotrexate in porcine skin and found that methotrexate distribution and concentration in the mid-dermis was facilitated by ablative fractional laser, suggesting that ablative fractional laser-assisted topical methotrexate-delivery may be an appropriate alternative to systemic methotrexate for some skin disorders.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Age>18 years
- •Patients with stable acral or acrofacial vitiligo and nonsegmental vitiligo having bilateral symmetrical lesions.
- •Two independent areas of size at least 1 x 1 cm or a single lesion with minimal size of at least 2 x 2 cm.
- •Patients who have not undergone any surgical management for the vitiligo.
排除标准
- •Patients with active vitiligo with signs of active vitiligo like confetti- like depigmentation, new lesions in the surrounding area, or the extension of existing lesions in the last 12 weeks.
- •History of keloidal tendency/hypertrophic or keloidal scarring
- •Collagen vascular disease and bleeding disorders
- •Any active bacterial, fungal or viral infection over the lesional site
- •Pregnant and lactating females
- •Age less than 18 years
- •Patients on anticoagulant therapy or aspirin
- •Patients with an unrealistic expectation.
结局指标
主要结局
Proportion of patients achieving 50% reduction in lesional vitiligo area & severity index (VASI) from baseline at five months.
时间窗: 5 months
次要结局
- • Time to achieve a 50% reduction in lesional VASI from baseline.(• Proportion of patients achieving 75% reduction in lesional VASI from baseline at five months.)