DRKS00015717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 14 人开始时间: 2018年11月5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
- 14
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
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 23 Years（—）
- 性别
- All
入选标准
- •Healthy female and male volunteers,
- •- Age 16 - 23 years
- •- Subjects with skin prone to acne and lesions up to grade 4 on the Leeds scale.
- •- Subjects who are free of anti-acne or antiseborrheic topical medical treatments until at least 2 weeks before the start of the study.
- •- subjects without topical retinoid treatment, for at least 2 weeks before the start of the study
- •- subjects who did not receive oral retinoid therapy for at least two months prior to the start of the study
- •- subjects without topical and oral antibiotic treatment for at least 4 weeks prior to the start of the study
- •- Subjects who are willing to cooperate and comply with the following requirements for the duration of the study:
- •- Use only the products provided on the face to replace their usual facial care products;
- •- Use make-up products for lips and eyes only.
- •- Do not manipulate the lesions (press, try to soft, etc.)
- •- Do not use peeling products on the face
- •- Subjects who are willing to report unwanted symptoms immediately
- •- Test persons who are able to read, understand and consent in writing
- •- subjects with constant contraception for at least 3 months before the start of the study and no planned change during the study
- •- test persons who are willing to refrain from swimming in chlorinated water
排除标准
- •- Subjects who cannot follow the requirements of the protocol
- •- Subjects planning to participate in another study or participating in one
- •- subjects with severe inflammatory lesions, greater than Grade 4 of the Leeds Score
- •- subjects who have skin irritations or damages in the whole face (area with desquamation, dryness, skin picking etc.)
- •- Subjects who treat themselves aesthetically (peeling, etc.), aesthetic care by a cosmetician (deep skin cleansing) or aesthetic treatments by a dermatologist (dermabrasion, peeling, laser, etc.) during the study period and at least 2 months before the start of the study.
- •- Test persons who have a disease or skin disease which, in the doctor's opinion, excludes participation
- •- subjects with active or localized or systemic infection
- •- volunteers with atopic skin diseases (atopic dermatitis, eczema, etc ...) except seasonal allergies
- •- subjects under topical treatment with acne medication within the last 2 weeks
- •- volunteers, under systemic treatment with cyclins intrahlb of the last month
- •- subjects under isotretinoin treatment
- •- Probands with vitamin B complex intake
- •- Women with oral contraception within the last 3 months before the start of the study or who plan to change their contraception within the duration of the study.
- •- women undergoing anti-androgen hormonal treatment (cyproterone acetate, CMA and others) within the last 3 months before the start of the study
- •- Women who are pregnant, breastfeeding or planning to become pregnant within 6 months.
- •- Men with a lot of facial hair and a full beard
- •subjects currently taking medication (e.g., oral or topical steroids, anti-inflammatory drugs) or either topical prescription drugs and / or over-the-counter (OTC) facial skin treatments
- •- Subjects who do not want to be photographed
- •subjects with a known allergy or hypersensitivity to any of the components of the test product
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