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

Not Applicable

Completed

• Conditions: Irritation/Irritant; Sensitisation

• Registration Number: NCT06884215
• Lead Sponsor: Amazentis SA

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 panel of healthy volunteers by means of repeated cutaneous patch applications under occlusion based on the modified Draize method

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-03-13
• Study First Submitted QC: 2025-03-13
• Study Start: 2025-03-17
• Study First Posted: 2025-03-19
• Primary Completion: 2025-04-28
• Study Completion: 2025-04-28
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-20
• Last Update Posted: 2025-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 112

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Skin safety as assessed by the number of adverse events of skin irritation and sensitization during human repeat insult patch testing (HRIPT)	6 weeks

Trial Locations

Locations (1)

PCR Corp; 🇬🇧 Manchester, United Kingdom