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

Last updated: March 31, 2025
Sponsor: Amazentis SA
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Mitopure Topical Formula 4

Mitopure Topical Formula 3

Clinical Study ID

NCT06884215
ASARIP2M
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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

Eligibility Criteria

Inclusion

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, bilateraloophorectomy, hysterectomy, post-menopausal for at least one year or male partnervasectomy).

Exclusion

Exclusion Criteria:

  • Pregnancy or lactation.

  • Participation in a repeat insult patch test (RIPT) or follow-up work within the lastmonth.

  • Current treatment by a physician for allergy unless physician consulted byInvestigator and participation approved.

Study Design

Total Participants: 100
Treatment Group(s): 2
Primary Treatment: Mitopure Topical Formula 4
Phase:
Study Start date:
March 17, 2025
Estimated Completion Date:
June 30, 2025

Connect with a study center

  • PCR Corp

    Manchester, M13 0AF
    United Kingdom

    Active - Recruiting

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