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

A Modified Draize Repeat Insult Patch Test in a Shared Panel of 100 Healthy Volunteers to Investigate the Irritation and Sensitization Potential of 6 Test Articles Following Repeated Cutaneous Patch Applications

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07100912
Acronym
GLOW-Safety-3
Enrollment
113
Registered
2025-08-03
Start date
2025-08-18
Completion date
2025-09-26
Last updated
2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Irritation/Irritant, Sensitisation

Keywords

HRIPT

Brief summary

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

Interventions

OTHERMitopure Topical Formula 5

Topical skin cream containing Mitopure

OTHERMitopure Topical Formula 6

Topical skin cream containing Mitopure

OTHERMitopure Topical Formula 7

Topical skin cream containing Mitopure

OTHERMitopure Topical Formula 8

Topical skin serum containing Mitopure

OTHERMitopure Topical Formula 9

Topical skin exfoliator containing Mitopure

OTHERMitopure Topical Formula 10

Topical skin cleanser containing Mitopure

Sponsors

Princeton Consumer Research
CollaboratorOTHER
Amazentis SA
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime 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

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026