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OpenTrials
Completed

NCT Number: NCT07517900

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

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

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

PCR Corp

Manchester, M13 0AF, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mitopure Topical Formula

Other

Topical skin serum containing Mitopure

Primary outcomes

  1. Skin Irritation

    Time frame: 2 weeks

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

Secondary outcomes

  1. 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;

    • = Rather agree;
    • = Fully agree

Sponsors and collaborators

Lead sponsor

Amazentis SA

Industry

Collaborators

  • Princeton Consumer Research

Registry information

Official study title

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

Acronym: SIU-1

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 8, 2026
Registry last updated
Jun 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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