ISRCTN16487219进行中（未招募）Unknown
Double-blind, placebo-controlled clinical assessment of the efficacy of a food supplement tested on Asian subjects with acne-prone skin
SYNBALANCE SR0 个研究点目标入组 64 人开始时间: 2024年1月26日最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 64
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Female
入选标准
- •1. Healthy Asian female subjects
- •2. Aged between 18 and 45 (extremes included) years old
- •3. Subjects showing acne severity from 1 to 3 according to IGA scale
- •4. Subjects who have not been recently involved in any other similar study
- •5. Willingness to use during all the study period only the product to be tested
- •6. Subjects certifying the truthfulness of the personal data disclosed to the investigator
- •7. Subjects able to understand the language used in the investigation center and the information given by the investigator
- •8. Subjects able to respect the instructions given by the investigator as well as able to respect the study constraints and specific requirements
- •9. The pharmacological therapy (except for the pharmacological therapy in the non-inclusion criteria) should be stable for at least one month without any changes expected or planned during the study
- •10. Commitment not to change the daily routine or the lifestyle
- •11. Subjects having signed their written Informed Consent form (ICF) and privacy form for their participation in the study and a photograph authorization.
排除标准
- •1. Subjects who do not fit the inclusion criteria;
- •2. Subjects with acute or chronic diseases able to interfere with the outcome of the study or that are considered dangerous for the subject or incompatible with the study requirements;
- •3. Subjects participating or planning to participate in other clinical trials;
- •4. Subjects deprived of freedom by administrative or legal decision or under guardianship;
- •5. Subjects not able to be contacted in case of emergency;
- •6. Subjects admitted to a health or social facility;
- •7. Subjects planning a hospitalisation during the study;
- •8. Subjects who participated in a similar study without respecting an adequate washout period;
- •9. Subjects having an acute, chronic or progressive illness liable to interfere with the study data or considered by the Investigator hazardous for the subject or incompatible with the study requirements;
- •10. Subjects with known hypersensitivity or allergy to one of the active ingredients;
- •11. Subjects under pharmacological treatments that are considered incompatible with the study requirement by the investigator as for example medication with photosensitizing potential, drugs specific for acne treatment as isotretinoin or antibiotics, and/or food supplements and specific local therapy for acne treatment, currently or during the month before the study start;
- •12. Subjects having a skin disease or condition liable to interfere with the study data or considered by the Investigator hazardous for the subject or incompatible with the study requirements;
- •13. Subjects that have shown allergies or sensitivity to cosmetic products, drugs, patch or medical devices;
- •14. Subject breastfeeding, pregnant or not willing to take necessary precautions to avoid pregnancy during the study (for the women of childbearing potential);
- •15. Consumption of food supplement(s) containing probiotic and/or for skin/hair/nail care currently or within the past 12 weeks before the study.
研究者
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