DRKS00011297已完成未知
Status, Volatility and development of skin microbiome in acne vulgaris and the effect of live skin bacteria on acne prone skin
niversitätshautklinik0 个研究点目标入组 48 人开始时间: 2017年5月16日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 48
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 16 Years 至 23 Years（—）
- 性别
- All
入选标准
- •Healthy female and male subjects,
- •- Age 16 – 23 years
- •- Subjects with an acne prone skin and lesions up to grade 4 according to the Leeds scale.
- •- Subjects free of anti-acneic or antiseborrheic topical medical treatment, for at least 2 weeks before the beginning of the study.
- •- Subjects free of topic retinoid treatment, for at least 2 weeks before the beginning of the study.
- •- Subjects free of oral retinoid therapy for at least 2 months before the beginning of the study.
- •- Subjects free of topic and oral antibiotic treatment for at least 4 weeks before the beginning of the study.
- •- Subjects willing to cooperate and participate by following requirements for the duration of the study:
- •To use only the provided products on the face in replacement of their usual face skin care products;
- •To use make-up products only for lips and eyes;
- •Not to manipulate with the lesions face (press, try to efface, etc.);
- •Not to use any exfoliating products on the face;
- •- Subjects willing to report immediately any adverse symptoms.
- •- Subjects able to read understand and provide written informed consent.
- •- Subjects having a stable means of contraception for at least 3 months before beginning of the study and not changing the means of contraception during the study.
- •- Subjects are willing to skip swimming in water with chlorine
排除标准
- •- Subjects unable to follow the requirements of the protocol.
- •- Subjects planning or undergoing another clinical study.
- •- Subjects presenting severe inflammatory lesions, above grade 4 Leeds score.
- •- Subjects presenting irritated or damaged skin on the whole face (area with desquamation, dryness, skin picking etc.).
- •- Subjects performing themselves aesthetic cares (scrub, etc.), aesthetic care by a beautician (deep skin cleansing) or undergoing aesthetic acts performed by the Dermatologist (dermabrasion, peeling, laser, etc.) during the study period and at least 2 months before the study begins.
- •- Subjects having any disease or skin condition that the examining investigator seems inappropriate for participation.
- •- Subjects having active or localized or systemic infection.
- •- Subjects with atopic skin diseases (atopic dermatitis, eczema, etc…) other than seasonal allergies.
- •- Subject stopping topical acne drugs for less than 2 weeks
- •- Subject stopping systemic cyclines for less than 1 month
- •- Subject under isotretinoin
- •- Subjects using / applying vitamin B complex
- •- Women under oral contraception for less than 3 months before the beginning of the study or planning to modify their contraception treatment within the duration of the study.
- •- Women having antiandrogenic hormonal treatment (cyproterone acetate, CMA and others) for less than 3 months before the beginning of the study.
- •- Women known to be pregnant, nursing or planning to become pregnant within 6 months.
- •- Male with lot of facial hair und full beard
- •- Subjects currently taking prescriptions medications (e.g. oral or topical steroids, anti-inflammatory drugs) or applying either topical prescriptions drugs and/or over-the-counter (OTC) skin treatments on the face.
- •- Subjects not willing to be photographed.
- •- Subjects with a known allergy or hypersensitivity to one of the constituents of the provided products.
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