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

Amazentis

Status

Completed

Conditions

Sensitisation

Irritation/Irritant

Treatments

Other: Mitopure Topical Formula 2

Other: Mitopure Topical Formula 1

Study type

Interventional

Funder types

Industry

Other

Identifiers

NCT05079607

ASARIP1M

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.
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.
A current skin disease of any type apart from mild facial acne (e.g. eczema, psoriasis) or has tattoos or excessive hair at the patch sites that would interfere with patching/skin evaluations.
Heavy alcohol consumption (i.e. more than 21 units per week or 8 units a day for men, more than 14 units per week or 4 units a day for women).
Current use or history of repeated use of street drugs.
A febrile illness lasting more than 24 hours in the six days prior to first patch application.
Significant past medical history of hepatic, renal, cardiac, pulmonary, digestive, haematological, neurological, locomotor or psychiatric disease.
Currently taking asthma medication or antihistamines for hay fever.
A history of multiple drug hypersensitivity.
Concurrent medication likely to affect the response to the test articles or confuse the results of the study (e.g. Anti-allergy, glucocorticoid, aspirin, non- steroidal anti-inflammatory, asthma or hay fever medication).
Known sensitivity to the test articles or their constituents including patch materials (for example tape/plaster adhesive).
Current treatment by a physician for allergy unless physician consulted by Investigator and participation approved.
Participation in a repeat insult patch test (RIPT) or follow-up work within the last month.
Sensitisation or questionable sensitisation in a RIPT.
Recent immunisation (less than 10 days prior to test patch application).
A medical history indicating atopy.