Actively Recruiting
A Clinical Safety Study of 1 Mitopure Topical Product in 30 Healthy Volunteers to Assess Skin Safety After Repeated Applications
Led by Amazentis SA · Updated on 2026-05-28
30
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
A
Amazentis SA
Lead Sponsor
P
Princeton Consumer Research
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety of a topical skin serum containing Mitopure in healthy adult volunteers. The study aims to assess any skin irritation or reactions after repeated applications of the test product. This clinical safety study involves a group of 30 healthy participants to understand how the product affects the skin over a short period. Participants will apply the Mitopure topical formula regularly as instructed during the study. They must only use this test article on themselves and avoid other facial serum products, cleansers, detergents, or fragrances throughout the study. The study does not involve a placebo or comparison group and does not use masking or blinding. Volunteers will attend all scheduled study visits where their skin will be examined for irritation and other traits related to product use. Researchers will monitor skin condition closely over two weeks to observe any changes or reactions. Participants will be asked to refrain from new medications or supplements unless allowed by the investigator, and the total study duration aligns with the two-week safety assessment period.
CONDITIONS
Brief Title
Human Skin Safety Testing of 1 Mitopure Topical Product Using a Clinical Safety in Use Study in Healthy Volunteers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy male and female participants aged 18 years or older
- Signed a written Informed Consent
- Agree to avoid new medications or herbal supplements during the study unless permitted by the investigator
- Do not have grade 3 or higher of any skin attribute according to the grading scale
- Willing to use only the test article on themselves and not use other facial serum products during the study
- Willing to attend all study visits and follow study instructions and prohibitions
- Agree to avoid using new facial serum products, cleansers, laundry detergents, and fragrances during the study
You will not qualify if you...
- Pregnant, nursing, or planning to become pregnant
- Current skin diseases such as eczema, psoriasis, rosacea, atopic dermatitis, or vitiligo
- Known allergy to face serum products or ingredients in the test article
- History of malignant disease
- Cuts, scratches, abrasions, rashes, scarring, birthmarks, or tattoos on the face that may interfere with assessments
- Significant past medical history of hepatic, renal, cardiac, pulmonary, digestive, hematological, neurological, locomotor, or psychiatric disease
- Known sensitivity to the test article or similar materials
- Use of sympathomimetics, antihistamines, or corticosteroids within seven days prior to study start
- Any medical condition that may affect study data or participant safety as judged by the investigator
- History of poor cooperation, non-compliance, or unreliability
- Investigator deems the participant unsuitable for the study
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 2 weeks
Participants apply the Mitopure Topical Formula to their skin repeatedly to assess skin safety.
Multiple visits during the 2 weeks as needed for assessments
Trial Site Locations
Total: 1 location
1
PCR Corp
Manchester, United Kingdom, M13 0AF
Actively Recruiting
Research Team
B
Brad Currier, PhD
A
Anurag Singh, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
BASIC_SCIENCE
Number of Arms
1
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