Subjective and Instrumental Evaluation of the Effects of Treatments With Two Sea Buckthorn Oil Products on Cutaneous Aging
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Decrease of signs of skin aging
研究概览
简要总结
The effect of oral supplementation of SBA24 sea buckthorn oil capsule and topical application of Omega7 sea buckthorn cream on skin ageing is studied in a single blind, parallel study.
详细描述
The study is carried out on two groups of female volunteers, 30 in each group, of age 30 to 60 years, in compliance with the principles established by the World Medical Association in the Declaration of Helsinki. In group I, the subjects took SBA24 sea buckthorn oil capsule (2 x 2 capsules per day) and apply two different creams on the face, one cream on each half of the face, twice per day. In group II, the subjects apply only the two creams, one cream on each half of the face, twice per day, for 8 weeks.
The assessment is performed on the skin surface of the periocular areas.
The efficacy of the active products is assessed on the skin face at the beginning, after 4 weeks and after 8 weeks of treatment using the following instrumental measurements:
- cutaneous elasticity (CUTOMETER SEM 575 Courage & Khazaka);
- cutaneous hydration level (CORNEOMETER CM 825 Combi 3 Courage & Khazaka);
- cutaneous roughness by cutaneous replicas and image analysis (Quantilines, Monaderm); Determination of benefit is based on instrumental measurements and subject self-assessment questionnaires.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female subjects 30 - 60 years old with Fitzpatrick skin type I-IV & in good general health, with facial skin manifestation related to photoaging (wrinkles, dyschromias, tissue looseness etc.)
- •Subjects must have discontinued the use of topical retinoid products for 6 months prior to study entry and of systemic retinoids for 1 year prior to study entry.
- •Subjects must have discontinued the use of topical alpha-hydroxy, &/or beta-hydroxy products for 45 days prior to study entry & all other topical facial medication to the skin immediately prior to study entry.
- •Subjects must have discontinued the use of systemic antiaging or antioxidant products for at least 2 months prior to study entry.
- •Subjects must be willing & able to follow all study directions & to commit to all follow-up visits for the duration of the study.
- •Subjects must have completed the informed consent process.
- •Subjects must be willing to avoid direct daily sun exposure on the face or the use of tanning beds.
排除标准
- •Pregnant or nursing females.
- •Subjects with a history of unusual skin reactions to skin care toiletry products, cosmetics, or sensitivity to any of the test article components.
- •Previous facial treatments with any dermal fillers (i.e. collagen, hyaluronic acid etc)
- •Concurrent therapy, systemic diseases, or skin disorders (such as eczema, psoriasis, severe acne etc.) which may interfere with the evaluation of the test articles or increase risk to the subject.
- •Subjects currently involved in another clinical investigation or who have been involved within a period of 30 days prior to admission in this study.
结局指标
主要结局
Decrease of signs of skin aging
时间窗: 8 weeks
次要结局
- Subjects self-assessment of the efficacy of the treatment(8 weeks)