CTRI/2022/08/044565已完成未知
An open-label, single-arm study to evaluate the efficacy and safety of a Body Firming Cream and Under Eye Gel in lactating female (post pregnancy mother having 0 month to 36 months old baby) subjects and only Under Eye Gel in healthy pregnant female (1st and 2nd trimester) subjects.
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 65
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)Lactating females
- •a.with diagnosis of cellulite with grades I to III according to Cellulite Severity Grading scale.
- •b.with stage 1 and stage 2 according to Nurnberger-Muller Cellulite Classification Scale
- •c.with Grade 2 and Grade 3 under eyes dark circles and under eyes puffiness as determined by 6-point grading scale.
- •d.Subjects having history of delivery within 42 weeks.
- •2)Healthy pregnant females
- •a.with Grade 2 and Grade 3 under eyes dark circles and under eyes puffiness as determined by 6-point grading scale.
- •b.Primipara (woman who is giving birth for the first time) subjects, who are diagnosed as pregnant female by gynaecologist.
排除标准
- •1)Subjects having varicose veins or history of phlebitis in the cellulite area or condition such as psoriasis, eczema, erythema, edema, scars, wounds and other visible lesions.
- •2)Subjects who have used some kind of cellulite-treatment in the last 30 days before beginning of the study or those who underwent any kind of surgical procedure in area of treatment, in past three months before the study.
- •3)Participation in a similar clinical study within the previous 90 days.
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