CTRI/2014/03/004476已完成不适用
Evaluating Non-Invasive Measurement Tools to Differentiate Cellulite Affected Skin from Normal Skin on Healthy Human Volunteers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- To study for difference in skin thickness, moisture, elasticity, viscoelasticity, smoothness, firmness and color recovery in cellulite accumulated skin vs. non cellulite accumulated skin through non-invasive instrumental measurements and visual evaluation.
研究概览
简要总结
| An observational/ non-interventional study. |
|Total 10 healthy human adult female subjects, of which at least 5 with visible cellulite on upper arms and / or thighs and remaining with no cellulite.
|Dermatologist’s visual assessment , Instrumental measurements-
1day of evaluation for each subject. Subjects might need to visit on anadditional day for screening and enrolment.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 20.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- Female
入选标准
- •â€¢Subjects willing to give written informed consent and abide by the study protocol.
- •â€¢10 healthy female subjects in the age group of 20 to 50 yrs.
- •â€¢At least 5 subjects with cellulite on at least one of the arms/ thighs and the remaining 5 with normal skin.
- •â€¢Subjects with no medical history of disease / medical condition/ concurrent illness/ pre-existing or dormant dermatologic condition that could interfere with the study results.
- •â€¢Subjects who are not pregnant or nursing.
- •â€¢Subjects who are willing to abstain from using any cosmetic product on the identified sites on the day of study.
排除标准
- •â€¢Subjects who are pregnant or lactating.
- •â€¢Subjects having skin disease (e.g. psoriasis, atopic dermatitis or other cutaneous manifestations), which would interfere with the test readings.
- •â€¢Subjects on medications (e.g. steroids or antihistamines), which could compromise the study results.
- •â€¢Subjects with scars, cuts/ wounds/ scratches on the potential test sites (Brachium region, Femoral regions and Volar forearm), which could interfere with the test readings.
结局指标
主要结局
To study for difference in skin thickness, moisture, elasticity, viscoelasticity, smoothness, firmness and color recovery in cellulite accumulated skin vs. non cellulite accumulated skin through non-invasive instrumental measurements and visual evaluation.
时间窗: single visit evaluation
次要结局
- To study the correlation between the varied evaluation tools available to measure skin cellulite.(Single visit evaluation)
研究者
研究点 (1)
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