Human Skin Safety Testing of 6 Mitopure Topical Products Using a Human Repeat Insult Patch Test (HRIPT) in Healthy Volunteers (GLOW-Safety-3)

Amazentis

Status

Not yet enrolling

Conditions

Sensitisation

Irritation/Irritant

Treatments

Other: Mitopure Topical Formula 8

Other: Mitopure Topical Formula 10

Other: Mitopure Topical Formula 9

Other: Mitopure Topical Formula 5

Other: Mitopure Topical Formula 6

Other: Mitopure Topical Formula 7

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT07100912

ASARIP3M

Details and patient eligibility

About

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

Enrollment

100 estimated 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.