Human Skin Safety Testing of 6 Mitopure Topical Products Using a Human Repeat Insult Patch Test (HRIPT) in Healthy Volunteers

NCT ID: NCT07100912

Last Updated: 2025-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

113 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-18

Study Completion Date

2025-09-26

Brief Summary

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The objective of this study is to investigate the irritation and sensitization potential of 6 different topically applied test articles containing 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

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Conditions

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Irritation/Irritant Sensitisation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Mitopure Topical Formula

Group Type EXPERIMENTAL

Mitopure Topical Formula 5

Intervention Type OTHER

Topical skin cream containing Mitopure

Mitopure Topical Formula 6

Intervention Type OTHER

Topical skin cream containing Mitopure

Mitopure Topical Formula 7

Intervention Type OTHER

Topical skin cream containing Mitopure

Mitopure Topical Formula 8

Intervention Type OTHER

Topical skin serum containing Mitopure

Mitopure Topical Formula 9

Intervention Type OTHER

Topical skin exfoliator containing Mitopure

Mitopure Topical Formula 10

Intervention Type OTHER

Topical skin cleanser containing Mitopure

Interventions

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Mitopure Topical Formula 5

Topical skin cream containing Mitopure

Intervention Type OTHER

Mitopure Topical Formula 6

Topical skin cream containing Mitopure

Intervention Type OTHER

Mitopure Topical Formula 7

Topical skin cream containing Mitopure

Intervention Type OTHER

Mitopure Topical Formula 8

Topical skin serum containing Mitopure

Intervention Type OTHER

Mitopure Topical Formula 9

Topical skin exfoliator containing Mitopure

Intervention Type OTHER

Mitopure Topical Formula 10

Topical skin cleanser containing Mitopure

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Healthy males or females,18 years of age or older (50% with sensitive skin).
* 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.
* Participation in a repeat insult patch test (RIPT) or follow-up work within the last month.
* Current treatment by a physician for allergy unless physician consulted by Investigator and participation approved.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Princeton Consumer Research

OTHER

Sponsor Role collaborator

Amazentis SA

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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PCR Corp

Manchester, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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ASARIP3M

Identifier Type: -

Identifier Source: org_study_id

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