Human Skin Safety Testing of 1 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 1 Test Article Following Repeated Cutaneous Patch Applications

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07517874

Acronym

GLOW-Safety-4

Enrollment

112

Registered

2026-04-08

Start date

2026-04-20

Completion date

2026-06-01

Last updated

2026-06-17

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 1 topically applied test article 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 11

Topical skin serum containing Mitopure

Study design

Allocation

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

Measure	Time 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: Jun 18, 2026