CTRI/2024/06/068757尚未招募Phase 3 4
A Double-Blind, Placebo-Controlled, Randomized, Parallel-group Study to Evaluate General Skin Health Benefits of Skin-ceraâ„¢ in Healthy Human Volunteers
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Change in the efficacy parameters assessed in the investigational product arm compared to placebo from baseline to end of study
研究概览
简要总结
This is a double blind, randomized, placebo controlled, two-arms, parallel group study. Healthy male and female subjects presenting dry skin, showing signs of skin aging, and meeting all inclusion and none of the exclusion criteria after signing a written informed consent will be enrolled in the study. After passing the eligibility criteria, the subjects will be randomized. Skin analysis will be performed in a subset population. Safety and Tolerability will be evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects presenting with dry skin and signs of photoaging.
- •Subjects not undergoing any supplementation for skin health.
- •Subject has not participated in a similar clinical investigation in the past three months.
- •Subject who is willing to abstain from using any fairness product, sunscreens, natural/ ayurvedic treatments or oral skin supplements or other home remedies and also willing to abstain from undergoing any facial treatments such as facial masks, packs, bleaching, etc either at home or at parlour during the entire study course.
- •In case of having used skin treatment in the near past, should be willing to undergo a wash out period of 1 week, wherein they should abstain from applying any product other than the provided cleanser on face.
- •Male subjects who are willing to maintain their facial skin condition as shaved at baseline and during the entire study course.
- •Female subjects of reproductive age group have negative urine pregnancy test (UPT) at screening visit.
- •Subject willing to give written informed consent and comply with the study procedures.
排除标准
- •Subject with a medical history of disease or condition or a concurrent illness or pre-existing or dormant dermatologic condition that could interfere with the study results.
- •2.Subject who has used any systemic medication within past 4 weeks or any topical facial medication within 2 weeks prior to study commencement, which could compromise the study.
- •3.Subject with excessive facial hair or scars, which could interfere with evaluation.
- •4.Subject with a history of having used a similar product during or since 1 week prior to the scheduled study commencement.
- •5.Subject who is currently pregnant or nursing or contemplating pregnancy during the study course.
- •6.Subjects will history of drug or alcohol abuse or chronic smoking.
- •7.Subjects allergic to herbal products or any component of the study product 8.Known HIV or Hepatitis B positive or any other immuno-compromised state 9.Currently participating or having participated in another clinical trial during the last 3 months prior to the beginning of this study 10.Any additional condition(s) that in the Investigators opinion would warrant exclusion from the study or prevent the subject from completing the study.
结局指标
主要结局
Change in the efficacy parameters assessed in the investigational product arm compared to placebo from baseline to end of study
时间窗: Baseline, Week 4, Week 8, Week 12
次要结局
- Safety and Tolerability(Baseline, Week 4, Week 8, Week 12)
研究者
Dr Sanjana A S
BGS Global Institute of Medical Sciences
研究点 (1)
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