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

NCT07517900 | Completed

• 1 other identifier: ASASIU1M
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Adult

Keywords

Safety In Use

Outcome Measures

Primary Outcomes (1)

• Skin Irritation

  Visual evaluation by an expert clinical grader at Baseline and Week 2 for skin condition.

  2 weeks

Secondary Outcomes (1)

• Product traits

  2 weeks

Study Arms (1)

Mitopure Topical Formula

EXPERIMENTAL

Other: Mitopure Topical Formula

Interventions

Mitopure Topical Formula OTHER

Topical skin serum containing Mitopure

Mitopure Topical Formula

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Amazentis SA: lead
• Princeton Consumer Research: collaborator

Study Sites (1)

PCR Corp

Manchester, M13 0AF, United Kingdom

Location

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: April 2, 2026
• First Posted: April 8, 2026
• Study Start: April 20, 2026
• Primary Completion: May 4, 2026
• Study Completion: May 4, 2026
• Last Updated: June 11, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)