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

NCT05079607 | Completed

• 1 other identifier: ASARIP1M
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Skin safety as assessed by the number of adverse events of skin irritation and sensitization during human repeat insult patch testing (HRIPT)

  6 weeks

Study Arms (1)

Mitopure Topical Formula

EXPERIMENTAL

Other: Mitopure Topical Formula 1; Other: Mitopure Topical Formula 2

Interventions

Mitopure Topical Formula 1 OTHER

topical skin cream containing the low dose mitophagy activator Mitopure

Mitopure Topical Formula

Mitopure Topical Formula 2 OTHER

topical skin cream containing the high dose mitophagy activator Mitopure

Mitopure Topical Formula

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Amazentis SA: lead
• Princeton Research Corporation: collaborator

Study Sites (1)

PCR Corp, 667A Stockport Road

Manchester, M12 4QE, United Kingdom

Location

Study Officials

• Anurag Singh, MD, PhD

  Amazentis SA

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2021
• First Posted: October 15, 2021
• Study Start: October 4, 2021
• Primary Completion: November 15, 2021
• Study Completion: November 15, 2021
• Last Updated: November 23, 2021

Record last verified: 2021-11

Locations

GB (1)