The Efficiency of Fractional-Laser Resurfacing Followed by Topical Tacrolimus 0.03% Cream Versus Topical Tacrolimus Alone in Stable Vitiligo: a Comparative Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 27
- 主要终点
- repigmentation
研究概览
简要总结
The aim the clinical trial was to find out whether fractional CO₂ laser sessions in combination with application of daily topical tacrolimus 0.03% would enhance the action of the drug and pose as a possible combination treatment option for stable vitiligo lesions. This combination treatment was applied to one side of the body and the response was compared to the response of the lesions on the other side of the body to daily topical tacrolimus 0.03% alone, which was used as control.
详细描述
Each patient included in the study received treatment A on the lesions on one side of his/her body, and treatment B on the other side.
Treatment A included 4 monthly sessions of fractional CO₂ laser on the lesions plus application of topical tacrolimus 0.03% (Tarolimus) on the lesions 6 hours after each session and twice daily in between the sessions and for 1 month after the last session.
Treatment B included only the application of topical tacrolimus 0.03% (Tarolimus) on the lesions twice daily for 5 months.
Fractional laser The device used was DEKA, SmartXide DOT (Dermal Optical Thermolysis), Italy fractional Carbon Dioxide Laser (fig. 8). This device is an ablative fractional 10,6000 nm CO² Laser with variable pulse duration (0.2-2 ms), 350-μm beam spot size, scanner area of 15x15 mm and penetration depth between 200 to 1,500 μm.
Tacrolimus ointment 0.03% (Tarolimus) Applied on the lesions treated by fractional CO² laser 6 hours after each laser session, then twice daily in between the sessions and 1 month after the last session.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Treatment A
Combination treatment of fractional carbon dioxide laser monthly sessions and topical tacrolimus 0.03% daily application (Tacrolimus Oint 0.03%)
干预措施: fractional carbon dioxide laser (Device)
Treatment A
Combination treatment of fractional carbon dioxide laser monthly sessions and topical tacrolimus 0.03% daily application (Tacrolimus Oint 0.03%)
干预措施: Tacrolimus Oint 0.03% (Drug)
Treatment B
Monotherapy with only topical tacrolimus 0.03% daily intervention: Tacrolimus Oint 0.03%
干预措施: Tacrolimus Oint 0.03% (Drug)
结局指标
主要结局
repigmentation
时间窗: 5 months
reduction in Vitiligo Area Scoring Index of lesions
次要结局
未报告次要终点
研究者
Nuhah Omar
Resident
Kasr El Aini Hospital