Microneedling Combined With Topical Crisaborole 2 % Ointment in Treatment of Vitiligo. A Prospective Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 主要终点
- Repigmentation of vitiligo lesions
研究概览
简要总结
The goal of this clinical trial is to learn if topical crisaborole ointment works to treat vitiligo. It will also learn about the safety of the drug. The main questions it aims to answer are:
Can the drug cause repigmentation of vitiligo lesions when used as topical form after microneedling? What medical problems do participants have when the drug used?
Participants will:
Visit the clinic once every 2 weeks to have the microneedling sessions for 3 months. and also they will have narrow band UVB sessions two times per week.
Record any side effect they have during or after the sessions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients suffer from non-segmental stable vitiligo.
- •Patients who will accept to be included in the study and will sign a written consent.
排除标准
- •Patients with history of koebnerization or any sign of disease activity.
- •Patients with keloid tendency.
- •Patients with active infection.
- •Pregnant or lactating woman.
研究组 & 干预措施
the main patch with microneedling and topical crisaborole and two patches as control
each patient will have 3 vitiligo patches one will be treated by microneedling and topical application of crisaborole and the other 2 patches will be considered as control patches
干预措施: microneedling with topical crisaborole (Procedure)
结局指标
主要结局
Repigmentation of vitiligo lesions
时间窗: 3 months from the start of treatment
The repigmentation responses will be expressed qualitatively as the following No change (0%-25%) = mild improvement (26%-50%) = moderate improvement (51%-75%) = good improvement (76%-100%) = excellent improvement
Repigmentation of vitiligo lesions
时间窗: 3 months from the start of treatment
The repigmentation responses will be expressed qualitatively as the following No change (0%-25%) = mild improvement (26%-50%) = moderate improvement (51%-75%) = good improvement (76%-100%) = excellent improvement
次要结局
未报告次要终点
研究者
Dina Hassan Moustafa Fahmy
Lecturer of Dermatology and Venereology
Tanta University