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Completed NCT07517900

Human Skin Safety Testing of 1 Mitopure Topical Product Using a Clinical Safety in Use Study in Healthy Volunteers

Conditions: Healthy Adult

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: Yes
Phase: NA
Enrollment: 40
Sponsor: Amazentis SA

Location: PCR Corp Manchester

Summary

The objective of this study is to investigate the safety of 1 topically applied test article containing Mitopure in a panel of healthy volunteers.

Eligibility Criteria

Inclusion Criteria: * Healthy male and female participants aged 18+. * Participant has signed a written Informed Consent. * Participant must agree to refrain from taking any new medications or herbal supplements during the study, unless permitted by the investigator. * Participant does not have grade of 3 or higher of any skin attribute per the grading scale. * Participant is willing to ONLY use the test article on themselves during the study as instructed and not use other facial serum products. * Participant is willing to attend all study visits and to follow the study instructions and prohibitions. * Participant must agree to refrain from using any new facial serum products, cleansers, laundry detergents, fragrances while participating in this study. Exclusion Criteria: * Participant is pregnant, nursing, or planning to become pregnant (by verbal response only). * Participant has a current skin disease of any type (e.g., eczema, psoriasis, rosacea, atopic dermatitis, vitiligo). * Participant has a known allergy to face serum products, or the ingredients included in the test article. * Participant has a history of malignant disease. * Participant has cuts, scratches, abrasions, rashes, scarring, birthmarks, or tattoos on their face that may interfere with assessments. * Participant has a significant past medical history of hepatic, renal, cardiac, pulmonary, digestive, haematological, neurological, locomotor or psychiatric disease. * Participant has a known sensitivity to the test article, similar materials, or their constituents. * Treatment or medication containing sympathomimetics, antihistamines or corticosteroids in the seven days prior to study start. * Medical condition that may affect study data or participant safety which in the opinion of the Investigator would compromise the safety of the participant or study results. * History of poor cooperation, non-compliance, or unreliability. * Investigator deems the participant an unsuitable candidate for the study.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07517900). StuddyBuddy aggregates publicly available trial information.