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

NCT ID: NCT05079607

Last Updated: 2021-11-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 112 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-04
• Study Completion Date: 2021-11-15

Brief Summary

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

Conditions

Irritation/Irritant; Sensitisation

Keywords

HRIPT

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Mitopure Topical Formula

Group Type: EXPERIMENTAL

Mitopure Topical Formula 1

Intervention Type: OTHER

topical skin cream containing the low dose mitophagy activator Mitopure

Mitopure Topical Formula 2

Intervention Type: OTHER

topical skin cream containing the high dose mitophagy activator Mitopure

Interventions

Mitopure Topical Formula 1

topical skin cream containing the low dose mitophagy activator Mitopure

Intervention Type: OTHER

Mitopure Topical Formula 2

topical skin cream containing the high dose mitophagy activator Mitopure

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Princeton Research Corporation

UNKNOWN

Sponsor Role: collaborator

Amazentis SA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anurag Singh, MD, PhD

Role: STUDY_DIRECTOR

Amazentis SA

Locations

PCR Corp, 667A Stockport Road

Manchester, , United Kingdom

Countries

United Kingdom

Other Identifiers

ASARIP1M

Identifier Type: -

Identifier Source: org_study_id