Human Skin Safety Testing of 1 Mitopure Topical Product Using a Clinical Safety in Use Study in Healthy Volunteers (SIU-1)

May 27, 2026 updated by: Amazentis SA

A Clinical Safety in Use Study of 30 Healthy Volunteers to Investigate the Safety of 1 Test Article Following Repeated Applications

The objective of this study is to investigate the safety of 1 topically applied test article containing Mitopure in a panel of healthy volunteers.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Healthy male and female participants aged 18+.
  • Participant has signed a written Informed Consent.
  • Participant must agree to refrain from taking any new medications or herbal supplements during the study, unless permitted by the investigator.
  • Participant does not have grade of 3 or higher of any skin attribute per the grading scale.
  • Participant is willing to ONLY use the test article on themselves during the study as instructed and not use other facial serum products.
  • Participant is willing to attend all study visits and to follow the study instructions and prohibitions.
  • Participant must agree to refrain from using any new facial serum products, cleansers, laundry detergents, fragrances while participating in this study.

Exclusion Criteria:

  • Participant is pregnant, nursing, or planning to become pregnant (by verbal response only).
  • Participant has a current skin disease of any type (e.g., eczema, psoriasis, rosacea, atopic dermatitis, vitiligo).
  • Participant has a known allergy to face serum products, or the ingredients included in the test article.
  • Participant has a history of malignant disease.
  • Participant has cuts, scratches, abrasions, rashes, scarring, birthmarks, or tattoos on their face that may interfere with assessments.
  • Participant has a significant past medical history of hepatic, renal, cardiac, pulmonary, digestive, haematological, neurological, locomotor or psychiatric disease.
  • Participant has a known sensitivity to the test article, similar materials, or their constituents.
  • Treatment or medication containing sympathomimetics, antihistamines or corticosteroids in the seven days prior to study start.
  • Medical condition that may affect study data or participant safety which in the opinion of the Investigator would compromise the safety of the participant or study results.
  • History of poor cooperation, non-compliance, or unreliability.
  • Investigator deems the participant an unsuitable candidate for the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mitopure Topical Formula
Other: Mitopure Topical Formula
Topical skin serum containing Mitopure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Skin Irritation
Time Frame: 2 weeks
Visual evaluation by an expert clinical grader at Baseline and Week 2 for skin condition.
2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Product traits
Time Frame: 2 weeks

Subjective evaluation of product traits assessed via questionnaire after 2 weeks.

Product traits will be assessed by the subjects with a list of closed questions with the following predefined identical options to tick:

2 = Fully disagree;

1 = Rather disagree;

  1. = Rather agree;
  2. = Fully agree
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amazentis SA

Collaborators

Princeton Consumer Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 20, 2026

Primary Completion (Estimated)

September 15, 2026

Study Completion (Estimated)

September 15, 2026

Study Registration Dates

First Submitted

April 2, 2026

First Submitted That Met QC Criteria

April 2, 2026

First Posted (Actual)

April 8, 2026

Study Record Updates

Last Update Posted (Actual)

May 28, 2026

Last Update Submitted That Met QC Criteria

May 27, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ASASIU1M

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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