Skin safety testing of a Mitopure topical product using a repeat-insult patch test
A Modified Draize Repeat Insult Patch Test in a Shared Panel of 100 Healthy Volunteers to Investigate the Irritation and Sensitization Potential of 1 Test Article Following Repeated Cutaneous Patch Applications
This test will check whether a Mitopure topical product causes skin irritation or allergic sensitization in healthy adults, including people with sensitive skin.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Amazentis SA Industry-sponsored |
| Locations | 1 site (Manchester) |
| Trial ID | NCT07517874 on ClinicalTrials.gov |
What this trial studies
This interventional HRIPT uses repeated occluded patch applications of a Mitopure topical formula on healthy adult volunteers to detect irritation and sensitization using a modified Draize method. About half of enrolled participants will have self-reported sensitive skin, and female participants of childbearing potential must use acceptable contraception. Key exclusions include pregnancy or lactation, recent participation in a RIPT, or current allergy treatment without investigator-approved physician clearance. The single-site protocol includes induction (repeated exposures) followed by a challenge phase to identify delayed hypersensitivity reactions.
Who should consider this trial
Good fit: Ideal candidates are healthy adults aged 18 or older, roughly half with self-reported sensitive skin, who can provide informed consent and meet contraception requirements if female.
Not a fit: People who are pregnant or breastfeeding, recently participated in a RIPT, or are receiving active allergy treatment without physician clearance are unlikely to benefit from participating.
Why it matters
Potential benefit: If the product shows low irritation and sensitization rates, consumers and manufacturers would gain confidence that the Mitopure topical formula is safe for typical use.
How similar studies have performed: Repeat-insult patch testing is a standard, well-established method and many similar HRIPTs for topical products have successfully identified irritants and sensitizers.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Manchester
- PCR Corp — Manchester, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Brad Currier, PhD
- Email: bcurrier@timeline.com
- Phone: +41215521272
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.