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

Not Applicable

Completed

• Conditions: Irritation/Irritant; Sensitisation
• Interventions: Other: Mitopure Topical Formula 1; Other: Mitopure Topical Formula 2

• Registration Number: NCT05079607
• Lead Sponsor: Amazentis SA

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

Detailed Description

Not available

Study Timeline

• Study Start: 2021-10-04
• Study First Submitted: 2021-10-04
• Study First Submitted QC: 2021-10-04
• Study First Posted: 2021-10-15
• Status Verified: 2021-11
• Primary Completion: 2021-11-15
• Study Completion: 2021-11-15
• Last Update Submitted: 2021-11-22
• Last Update Posted: 2021-11-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 112

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Mitopure Topical Formula	Mitopure Topical Formula 1	-
Mitopure Topical Formula	Mitopure Topical Formula 2	-

Primary Outcome Measures

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

Trial Locations

Locations (1)

PCR Corp, 667A Stockport Road; 🇬🇧 Manchester, United Kingdom