Human Skin Safety Testing of 6 Mitopure Topical Products Using a Human Repeat Insult Patch Test (HRIPT) in Healthy Volunteers

Launched by AMAZENTIS SA · Jul 28, 2025

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ClinConnect Summary

This clinical trial is studying the safety of six different skin products that contain an ingredient called Mitopure. The goal is to see if these products cause any skin irritation (like redness or itching) or allergic reactions when used repeatedly on healthy volunteers. To do this, small patches with the products will be placed on the skin multiple times to check for any signs of irritation or sensitivity.

People who are healthy adults aged 18 or older may be eligible to join, including both men and women. About half of the participants should have sensitive skin. Women who can become pregnant need to agree to use birth control during the study to ensure safety. Participants should not be pregnant or breastfeeding and should not have recently taken part in a similar skin test. If chosen, participants will have patches applied to their skin several times and will be monitored for any skin reactions. This study is not yet open for enrollment.

Gender

ALL

Eligibility criteria

• 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.