Placebo-controlled assessment of the efficacy of a food supplement in improving face skin conditions and cellulite derived skin imperfections

ROELMI HPC0 个研究点目标入组 66 人开始时间: 2023年3月16日最近更新: 2024年1月8日

适应症

试验速览

•1. Healthy female subjects
•2. Age between 35 and 65 (extremes included) years old
•3. Phototype I to IV included, according to Fitzpatrick classification
•4. Subjects showing fine lines/light wrinkles, dull skin and uneven skin tone
•5. Subjects showing mild to moderate cellulite-derived skin imperfections
•6. 10 subjects per group showing visible dark circles
•7. 10 subjects per group showing visible eyebags
•8. Subjects who have not been involved in any other similar in the last 3 months
•9. Subjects registered with Nation Health Service (NHS),
•10. Subjects certifying the truthfulness of the personal data disclosed to the investigator
•11. Subjects able to understand the language used in the investigation center and the information given by the investigator
•12. Subjects able to respect the instructions given by the investigator as well as able to respect the study constraints and specific requirements
•13. 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
•14. Commitment not to change the daily routine or the lifestyle
•15. Subjects who have not been recently involved in any other similar study
•16. Subjects having signed their written Informed Consent form (ICF) for their participation in the study and a photograph authorization

•1. Subject does not meet 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 hospitalization 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 under pharmacological treatments that are considered incompatible with the study requirement by the investigator
•11. 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
•12. Subjects that have shown allergies or sensitivity to cosmetic products, drugs, patch or medical devices
•13. Subject breastfeeding, pregnant or not willing to take necessary precautions to avoid pregnancy during the study (for the women of childbearing potential)

发起方

ROELMI HPC