NCT07431203已完成不适用
Clinical Trial Investigating the Relationship Between Skin Microbiome, Epigenetic Biological Age and Facial Morphological Features in Aging Context
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Skin microbiome
研究概览
简要总结
The goal of this observational study is to evaluate the effect of age on skin microbiome.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy subject;
- •Sex: female
- •Age: 50% having between 25 to 35 years old or 50% between 55 to 65 years old
- •Type: Caucasian
- •Phototype: I to III on the Fitzpatrick scale
- •Subject, having given freely and expressly her informed consent.
- •Subject, psychologically able to understand the study related information and to give a written informed consent;
- •Subject able to comply with protocol requirements;
- •Female of childbearing potential should use a medically accepted contraceptive regimen since at least 12 weeks before the beginning of the study and during all the study.
- •Women between 55 to 65 years old should be menopausal (last menstrual period at least 12 months before the screening visit
排除标准
- •Pregnant or nursing woman or planning a pregnancy during the study;
- •Subject who had been deprived of their freedom by administrative or legal decision or who is under guardianship;
- •Subject who is under guardianship or who is not able to express her consent;
- •Subject in a social or sanitary establishment;
- •Subject suspected to be non-compliant according to the investigator's judgment;
- •Subject having received 6000 euros indemnities for participation in a clinical research in the 12 previous months, including participation in the present study;
- •Subject enrolled in another clinical trial or which exclusion period is not over.
- •Subject with a condition or receiving a medication which, in the investigator's judgment, put the subject at undue risk or which may interfere with the evaluation;
- •Subject suffering from a severe or progressive disease.
- •Subject with current cutaneous inflammatory or infectious processes (eg, acne, herpes), abscess, an unhealed wound, or a cancerous or precancerous lesion on the face that could interfere with the evaluation.
- •Subject with a tattoo, a scar, moles, acne, too many hairs or anything on the studied zones which might interfere with the evaluation.
- •Subject having received injection on the face with botulinum toxin in the year before the screening.
- •Subject having received injection of filling product on the face in the year before the screening visit.
- •Subject having received injection of mesotherapy in the face in the past 6 months before the screening visit.
- •Subject having done a superficial or medium peeling or a superficial scrub on the face within the 2 previous months.
- •Subject having received tensor threads on the face in the two years before the screening visit.
- •Subject having received treatment with a laser, ultrasound or radiofrequency treatment, a dermabrasion, a surgery, a chemical peeling or any other procedure based on active dermal response on the face within the past 6 months.
- •Subject having used LED mask in the three weeks before screening visit
- •Subject undergoing a topical treatment on the face or a systemic treatment:
- •anti-inflammatory medication and/or anti-histamines during the previous 2 weeks and during the study;
- •corticosteroids during the 2 previous weeks and during the study;
- •retinoids, anti-acne treatment and/or immunosuppressors during the 3 previous months and during the study;
- •any medication stabilized for less than one month.
- •Subject having started or changed her oral contraceptive treatment during the three previous months.
- •Subject under oral hormonal substitutive treatment during the year previous the screening visit
- •Intensive exposure to sunlight or UV-rays within the previous month and/or foreseen during the study;
- •Subject having changed her life habits within the previous month and/or during the study;
- •Subject with an excessive consumption of alcohol (more than 2 glasses of wine per day) and/or tobacco (more than 10 cigarettes per day).
- •Subject having started or changed her face care products and or make-up within the previous month
研究组 & 干预措施
old
between 55 to 65 years old
young
between 25 to 35 years old
结局指标
主要结局
Skin microbiome
时间窗: single time point
次要结局
- skin face measurement(single time point)
- Epigenetic biological age(single time point)
研究者
研究点 (1)
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