Status:
COMPLETED
Human Skin Safety Testing of Mitopure Topical Products Using a Human Repeat Insult Patch Test (HRIPT) in Healthy Volunteers
Lead Sponsor:
Amazentis SA
Collaborating Sponsors:
Princeton Research Corporation
Conditions:
Irritation/Irritant
Sensitisation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 pane...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 17 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 28 2025
Estimated Enrollment :
112 Patients enrolled
Trial Details
Trial ID
NCT06884215
Start Date
March 17 2025
End Date
April 28 2025
Last Update
May 21 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
PCR Corp
Manchester, United Kingdom, M13 0AF