Human Skin Safety Testing of Mitopure Topical Products Using a Human Repeat Insult Patch Test (HRIPT) in Healthy Volunteers (GLOW-Safety-2)

Amazentis

Status: Completed

Conditions: Sensitisation; Irritation/Irritant

Treatments: Other: Mitopure Topical Formula 4; Other: Mitopure Topical Formula 3

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT06884215

ASARIP2M

Details and patient eligibility

About

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

Enrollment: 112 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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112 participants in 1 patient group

Mitopure Topical Formula

Experimental group

Treatment:

Other: Mitopure Topical Formula 3

Other: Mitopure Topical Formula 4