CTRI/2024/03/064874尚未招募2 期
A clinical study to assess the effectiveness of ayurvedic product in reduction in dark spots
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Significant reduction in severity of dark spots
研究概览
简要总结
The objective of the present clinical study is to investigate the efficacy of test products in controlling /reduicng the severity of dark spots. Study volunteers will be selected basis inclusion and exclusion criteria. Post informed consent, volunteers will be enrolled into the study and undergo 3 days of wash off. Subjects are provided with the test product and usage instructions will be provided. Volunteers will visit the venue and dermatological and instrumental assessments will be performed at Baseline, week 2 and week 4.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •1.Healthy females volunteers between 20-45 years of age.
- •2.Subjects with self perceived dark spot problems.
- •3.Presence of 2-3 spots on face 4.Volunteer in good health condition as per the medical screening criteria with no disease state or physical condition that the Investigator believes could interfere with the interpretation of the data.
- •5.Subject free of excessive hair, acne, cuts, abrasions, fissures, wounds, lacerations, or any other active skin conditions on the face.
- •6.Subject who agree not to use of any other skin lightening product/treatment/soap bar/home remedy on their face during the study period other that the study product provided.
- •7.Subject who agrees not to carry out bleaching or any other skin care procedures on face during the study 8.Volunteer able to read, understand and sign an appropriate informed consent form indicating her willingness to participate.
排除标准
- •1.Volunteers who participated in a study with face as the target area within 4 weeks of the start of this study or is currently participating in such a study.
- •2.Volunteer pregnant or planning to become pregnant.
- •3.Volunteers who are breastfeeding or having stopped to breastfeed in the past three months.
- •4.Volunteers with any other signs of significant local irritation, erythema or skin disease on face as well as on the visible parts of the body skin site.
- •5.Volunteers with self-perceived sensitive skin.
- •6.Volunteers having chronic illness or had major surgery in the last year.
- •7.Volunteers undergoing any treatment of any skin condition on body.
- •8.Volunteers taking any oral antibiotic medication currently or within the last 8 weeks.
- •9.Volunteers taking medication 10.Volunteers taking medication for any condition which the Investigator believes may influence the interpretation of the data.
- •11.Volunteers on food supplements.
结局指标
主要结局
Significant reduction in severity of dark spots
时间窗: Baseline, 2week, 4 week
次要结局
未报告次要终点
研究者
Dr Raji Patil
MASCOT-SPINCONTROL India Pvt. Ltd.
研究点 (1)
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