Human Skin Safety Testing of 6 Mitopure Topical Products Using a Human Repeat Insult Patch Test (HRIPT) in Healthy Volunteers
GLOW-Safety-3
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
1 other identifier
interventional
113
1 country
1
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2025
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 28, 2025
CompletedFirst Posted
Study publicly available on registry
August 3, 2025
CompletedStudy Start
First participant enrolled
August 18, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 26, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
September 26, 2025
CompletedNovember 17, 2025
November 1, 2025
1 month
July 28, 2025
November 14, 2025
Conditions
Keywords
Outcome Measures
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)
6 weeks
Study Arms (1)
Mitopure Topical Formula
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amazentis SAlead
- Princeton Consumer Researchcollaborator
Study Sites (1)
PCR Corp
Manchester, M13 0AF, United Kingdom
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 28, 2025
First Posted
August 3, 2025
Study Start
August 18, 2025
Primary Completion
September 26, 2025
Study Completion
September 26, 2025
Last Updated
November 17, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will not share