RecruitingNot ApplicableNCT07517874

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


Sponsor

Amazentis SA

Enrollment

100 participants

Start Date

Apr 20, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 Years

Inclusion Criteria3

  • 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 Criteria3

  • 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.

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Interventions

OTHERMitopure Topical Formula 11

Topical skin serum containing Mitopure


Locations(1)

PCR Corp

Manchester, United Kingdom

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NCT07517874