Human Skin Safety Testing of Mitopure Topical Products Using a Human Repeat Insult Patch Test (HRIPT) in Healthy Volunteers

A Modified Draize Repeat Insult Patch Test in a Shared Panel of 100 Healthy Volunteers to Investigate the Irritation and Sensitization Potential of Test Articles Following Repeated Cutaneous Patch Applications

The objective of this study is to investigate the irritation and sensitization potential of multiple topically applied test articles (containing different concentrations of Mitopure), in a shared panel of healthy volunteers by means of repeated cutaneous patch applications under occlusion based on the modified Draize method

Inclusion Criteria:

• Healthy males or females,18 years of age or older (50% with sensitive skin).
• Completed written informed consent.
• Female subject agrees to use an acceptable method of birth control (e.g. abstinence, condoms, hormonal birth control, IUD, tubal ligation, hysterectomy, bilateral oophorectomy, hysterectomy, post-menopausal for at least one year or male partner vasectomy).

Exclusion Criteria:

• Pregnancy or lactation.
• Participation in a repeat insult patch test (RIPT) or follow-up work within the last month.
• Current treatment by a physician for allergy unless physician consulted by Investigator and participation approved.