CTRI/2022/08/044646已完成未知
An open-label, single-arm study to evaluate efficacy and safety of a cream in reducing skin pigmentation in healthy pregnant female (1st and 2nd trimester) and lactating female (post pregnancy mother having 0 month to 18 months old baby) subjects with Mild to Moderate Melasma.
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1)Sex: Females, either of the following
- •a.Healthy pregnant females (1st and 2nd trimester â?? preferably first half of the 2nd trimester).
- •b.Post-pregnant females (post pregnancy mother having 0 month to 18 months old baby) at the time of consent.
- •2)Subjects with mild to moderate melasma determined by Melasma Area and Severity Index (MASI) score.
- •3)Subjects having at least 2 hyperpigmentary spots on the face.
- •4)Atleast 10 subjects with hypopigmentation along with melasma and at least 2 hyperpigmentary spots on the face.
- •5)Subjects who have a history of delivery within 42 weeks (applicable for post-pregnant females only).
排除标准
- •1)Subjects who have pigmentation due to any other reason than exposure to UV light like result of hormonal changes, freckles.
- •2)Subjects with skin disease (e.g., moderate to severe acne vulgaris face or nodulocystic acne, psoriasis, atopic dermatitis or any other condition as per Investigators discretion), which would interfere with the assessment area.
- •3)Subjects having history of diabetes, acute cardiac and circulatory diseases, HIV, hepatitis.
- •4)Participation in a similar clinical study within the previous 90 days.
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