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
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- 1)Dermatological assessment of cellulite of thighs, buttocks and hips using Nurnberger-Muller Scale.
研究概览
简要总结
The potentialsubjects will be screened as per the inclusion and exclusion criteria onlyafter obtaining written informed consent from the subjects.
There are total 7 visits in the study i.e.
· Visit 01:Screening Visit (within 30 days prior to day 01)
· Visit 02:Enrollment (Day 01)
· Visit 03:Evaluation phase (Day 14)
· Visit 04:Evaluation phase (Day 28)
· Visit 05:Evaluation phase (Day 42)
· Visit 06:Evaluation phase (Day 56)
· Visit 07:Evaluation phase and End of the study (Day 84)
Before entering the facility, at security check-post,subjects will be asked for pre-entry scrutiny check for COVID-19 symptoms.Study can be conducted in multiple batches (set of subjects) in order to followthe norms of covid-19 restrictions.
Instrumental assessment, dermatological assessmentsand questionnaires will be assessed. Photographs of the affected area will alsobe taken. Safety will be assessed throughout the study by monitoring of adverseevents.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 22.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- Female
入选标准
- •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.
- •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
- •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.
- •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.
- •Participation in a similar clinical study within the previous 90 days.
结局指标
主要结局
1)Dermatological assessment of cellulite of thighs, buttocks and hips using Nurnberger-Muller Scale.
时间窗: Baseline, Day 14, Day 28, Day 42, Day 56 and Day 84
2)Measurement of circumference of the thighs, buttocks and hips.
时间窗: Baseline, Day 14, Day 28, Day 42, Day 56 and Day 84
3)Dermatological assessment of skin tonicity of the thighs, buttocks and hips using Cellulite Severity Grading scale.
时间窗: Baseline, Day 14, Day 28, Day 42, Day 56 and Day 84
4)Dermatological assessment of under eyes dark circles using 6-point grading scale.
时间窗: Baseline, Day 14, Day 28, Day 42, Day 56 and Day 84
5)Dermatological assessment of under eye puffiness using Investigator’s Global Assessment Scale.
时间窗: Baseline, Day 14, Day 28, Day 42, Day 56 and Day 84
6)Dermatological assessment of under eye fine lines using Allergan Fine Lines Scale.
时间窗: Baseline, Day 14, Day 28, Day 42, Day 56 and Day 84
次要结局
- Assessment of skin elasticity of thighs, buttocks and hips using Cutometer.(Baseline, Day 14, Day 28, Day 42, Day 56 and Day 84)
- Assessment of skin hydration of thighs, buttocks and hips using Corneometer/ Moisturemeter SC.(Baseline, Day 14, Day 28, Day 42, Day 56 and Day 84)
- Assessment of skin barrier function of thighs, buttocks and hips using TEWAmeter/Vapometer.(Baseline, Day 14, Day 28, Day 42, Day 56 and Day 84)
- Assessment of under eye dark circles and under eye fine lines by image analysis.(Baseline, Day 14, Day 28, Day 42, Day 56 and Day 84)
- Subject Satisfaction Questionnaire and Product Response Index (Perception about Product).(Baseline, Day 14, Day 28, Day 42, Day 56 and Day 84)
- 6)Digital photographs of thighs, buttocks and/or hips and photographs of under eye area will be taken using Visia CR(Baseline, Day 14, Day 28, Day 42, Day 56 and Day 84)