CTRI/2017/06/008845尚未招募4 期
An open label, Randomized, Comparative study of Efficacy and Safety of Melbild Solution plus Tacrolimus 0.1% Ointment versus Tacrolimus 0.1% Ointment in the Treatment of Vitiligo - MELT
Alkem Laboratories Limited0 个研究点目标入组 120 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Pms
入排标准
入选标准
- •1. Male and Female subject in between 18 to 65 years of age
- •2. Subjects diagnosed with stable vitiligo (Stable vitiligo as no new significant macules and no progression of existing macules for >= 6 months) during the screening
- •3. Subjects with vitiligo lesion over Body Surface area <= 10%
- •4. Subjects who have not received any treatment for vitiligo in the last 3 months
- •5. Subjects willing to visit the clinic as per the predefined schedule
排除标准
- •1. Subjects with known history of skin cancer
- •2. Subjects with known history of photosensitive disorders
- •3. Subjects with known history of major medical co-morbidities like serious cardiovascular/cerebral/renal/hepatic diseases
- •4. Subjects on systemic therapies for vitiligo in the last 3 months
- •5. Subjects on topical therapyâ??s e.g. steroids class 3 or stronger in the last 3 months.
- •6. Subjects who has undergone recent or concurrent phototherapy like Narrow Band -UVB phototherapy, PUVA etc.
- •7. Subject is of reproductive potential and is not using adequate contraceptive precautions, in the judgment of the investigator
- •8. Subject is pregnant or breast feeding
研究者
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