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

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

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.