Human Skin Safety Testing of 1 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 1 Test Article Following Repeated Cutaneous Patch Applications

The objective of this study is to investigate the irritation and sensitization potential of 1 topically applied test article containing 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.