RecruitingNot ApplicableNCT07517900

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

A Clinical Safety in Use Study of 30 Healthy Volunteers to Investigate the Safety of 1 Test Article Following Repeated Applications

Sponsor

Amazentis SA

Enrollment

30 participants

Start Date

Apr 20, 2026

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

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.

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.