A study to evaluate the efficacy of the oral supplement in providing various skin benefits in healthy female subjects
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- 1. Improvement in wrinkles, fine lines and dark spots at different timepoints in
研究概览
简要总结
The aim of the study is to determine the efficacy of the test product (oral supplement) in providing skin benefits. Subjects will be screened and enrolled based on inclusion and exclusion criteria. Dermatological and instrumental assessments to evaluate skin colour, skin tone, fine lines and wrinkles, skin hydration and water barrier will be conducted at baseline, week 1, week 2 and week 4 time points.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 25.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- Female
入选标准
- •Female adult subjects in general good health as determined from a recent medical history, general physical examination, dermatological assessment.
- •Subjects in the age group of 25-65 years both ages inclusive.
- •Subjects with skin phototype III to V, min 50% subjects need to be phototype III.
- •Subjects with close resemblance to the Thai population.
- •Subject presenting at least 1 well defined dark spot on the face.
- •Subjects free of excessive hair, acne, cuts, abrasions, fissures, wounds, lacerations, or any other active skin conditions on the face as determined by the dermatologist.
- •Subject who agrees not to use any other product or treatment or home remedy except the provided product on their face during the study period other than the test product.
- •Subjects who agree not to carry out bleaching or any other procedures including facial etc.
- •on face during the study period.
- •Subjects who agree not to have direct and excessive sun exposure, not more than half an hour daily and during that time use of umbrella to cover face.
- •Subjects willing to give a voluntary written informed consent, photography release and agree to come for regular follow-up.
- •Subjects willing to abide by and comply with the study protocol.
排除标准
- •Subject with any other signs of significant local irritation or skin disease.
- •Subject currently taking any medication, which the Investigator believes may have an impact on the skin and study results.
- •Subject having clinically significant systemic or cutaneous disease, chronic illness or had major surgery in the last year.
- •Subjects undergoing any treatment of any skin condition on their face
- •Subjects not willing to discontinue other topical facial products.
- •Subject allergic or sensitive to bar, cleansing products, cosmetics, creams/lotions, artificial jewelery or anything else.
- •Subjects who are pregnant or nursing.
- •Subjects on any medical treatment either systemic or topical in the past 1 month or currently taking medication including food supplements.
结局指标
主要结局
1. Improvement in wrinkles, fine lines and dark spots at different timepoints in
时间窗: baseline, week 1, week 2, week 4
comparison to the baseline using Antera and dermatological evaluations.
时间窗: baseline, week 1, week 2, week 4
2. Improvement in skin hydration at all defined timepoints in comparison to
时间窗: baseline, week 1, week 2, week 4
the baseline using Corneometer.
时间窗: baseline, week 1, week 2, week 4
3. Improvement in skin water barrier function at all defined timepoints
时间窗: baseline, week 1, week 2, week 4
in comparison to the baseline using TEWL.
时间窗: baseline, week 1, week 2, week 4
4. Improvement in the skin color in comparison to baseline at all defined timepoints using Spectrophotometer.
时间窗: baseline, week 1, week 2, week 4
5. Improvement in skin attributes in comparison to baseline at all defined timepoints using and in skin attributes using VISIA CR imaging.
时间窗: baseline, week 1, week 2, week 4
次要结局
- To evaluate dermatological safety and tolerability of the test product under(regular (once daily) intake for 4 weeks.)
研究者
Dr Roshni Rai
MS Clinical Research Pvt. Ltd.