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

A Modified Draize Repeat Insult Patch Test in a Shared Panel of 50/100 Healthy Volunteers, to Investigate the Irritation and Sensitization Potential of Test Articles Following Repeated Cutaneous Patch Applications

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

Study Overview

• Status: Completed
• Conditions: Irritation/Irritant; Sensitisation
• Intervention / Treatment: Other: Mitopure Topical Formula 1; Other: Mitopure Topical Formula 2

• Study Type: Interventional
• Enrollment (Actual): 112
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Manchester, United Kingdom, M12 4QE
    • PCR Corp, 667A Stockport Road

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Mitopure Topical Formula	Other: Mitopure Topical Formula 1; topical skin cream containing the low dose mitophagy activator Mitopure; Other: Mitopure Topical Formula 2; topical skin cream containing the high dose mitophagy activator Mitopure

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Amazentis SA
• Collaborators: Princeton Research Corporation

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 4, 2021
• Primary Completion (ACTUAL): November 15, 2021
• Study Completion (ACTUAL): November 15, 2021

Study Registration Dates

• First Submitted: October 4, 2021
• First Submitted That Met QC Criteria: October 4, 2021
• First Posted (ACTUAL): October 15, 2021

Study Record Updates

• Last Update Posted (ACTUAL): November 23, 2021
• Last Update Submitted That Met QC Criteria: November 22, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: HRIPT
• Other Study ID Numbers: ASARIP1M

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No