A Single Center, Application Site Randomized, Blinded, Moisturization Study to Evaluate the Moisturization Properties of Test Products in Healthy Adult Human Participants.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Instrumental and Dermatological Assessment
研究概览
简要总结
A single center, blinded, application site-randomized, four-arm, moisture kinetics study.
The potential participants will be screened as per the inclusion and exclusion criteria only after obtaining written informed consent from the participants.
All eligible participants will undergo clinical evaluation by a Dermatologist, instrument evaluation and subjective evaluation. Safety will be assessed throughout the study by monitoring adverse events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •Healthy males and non-pregnant/non-lactating females (Preferably equal ratio) with age 18 to 50 years (both inclusive at the time of consent).
- •Participants having good general health as determined by the Investigator on the basis of medical history.
- •Female participants of childbearing potential must have a negative urine pregnancy test performed at enrollment visit.
- •Participants willing to abstain from using any cosmetic product on test sites, during the course of the study.
排除标准
- •Participants using Body milk /lotion / cream, cosmetics or any other body moisturizing product 3-5 days prior to study.
- •Participants who are on systemic medication or any medications would compromise the study.
- •Chronic illness which may influence the cutaneous state.
- •Participant having skin irritation, blemishes, excessive hair, moles, pigmentation, pimples, marks (e.g., tattoos, scars, and sunburn), open wounds, cuts, abrasions, irritation symptoms or any dermatological condition on the test site(s) i.e., volar forearm that can interfere with the reading.
- •Participants with known allergy or sensitivity to cosmetic products and/or any ingredients of the test product.
结局指标
主要结局
Instrumental and Dermatological Assessment
时间窗: Day 01 [(Before application (i.e., baseline)] and after application at 30 mins(+05 mins) and 06 hours (+15 mins)] and 12 hours (+15 mins) on Day 01, on Day 02 [24 hours (+15 mins) and 36 hours (+15 mins) after application] and on Day 03 [48 hours (+15 mins) after application]
次要结局
- Subjective Evaluation(Day 01 [30 mins(Plus 05 mins) after application] and Day 03 [48 hours (Plus 15 mins) after application])
研究者
Dr Bhagirath Patel
Cliantha Research