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OpenTrials
Completed

NCT Number: NCT07100912

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

The objective of this study is to investigate the irritation and sensitization potential of 6 different topically applied test articles containing Mitopure in a shared panel of healthy volunteers by means of repeated cutaneous patch applications under occlusion based on the modified Draize method

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Key information

Conditions

Irritation/Irritant Sensitisation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

PCR Corp

Manchester, M13 0AF, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mitopure Topical Formula 5

Other

Topical skin cream containing Mitopure

Mitopure Topical Formula 6

Other

Topical skin cream containing Mitopure

Mitopure Topical Formula 7

Other

Topical skin cream containing Mitopure

Mitopure Topical Formula 8

Other

Topical skin serum containing Mitopure

Mitopure Topical Formula 9

Other

Topical skin exfoliator containing Mitopure

Mitopure Topical Formula 10

Other

Topical skin cleanser containing Mitopure

Primary outcomes

  1. Skin safety as assessed by the number of adverse events of skin irritation and sensitization during human repeat insult patch testing (HRIPT)

    Time frame: 6 weeks

Sponsors and collaborators

Lead sponsor

Amazentis SA

Industry

Collaborators

  • Princeton Consumer Research

Registry information

Official study title

A Modified Draize Repeat Insult Patch Test in a Shared Panel of 100 Healthy Volunteers to Investigate the Irritation and Sensitization Potential of 6 Test Articles Following Repeated Cutaneous Patch Applications

Acronym: GLOW-Safety-3

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Aug 3, 2025
Registry last updated
Nov 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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