NCT06884215

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
112

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 13, 2025

Completed
4 days until next milestone

Study Start

First participant enrolled

March 17, 2025

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 19, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 28, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 28, 2025

Completed
Last Updated

May 21, 2025

Status Verified

May 1, 2025

Enrollment Period

1 month

First QC Date

March 13, 2025

Last Update Submit

May 20, 2025

Conditions

Irritation/IrritantSensitisation

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 3Other: Mitopure Topical Formula 4

Interventions

Mitopure Topical Formula 3OTHER

Topical skin cream containing Mitopure

Mitopure Topical Formula
Mitopure Topical Formula 4OTHER

Topical skin cream containing Mitopure

Mitopure Topical Formula

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PCR Corp

Manchester, M13 0AF, 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

March 13, 2025

First Posted

March 19, 2025

Study Start

March 17, 2025

Primary Completion

April 28, 2025

Study Completion

April 28, 2025

Last Updated

May 21, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)