Human Skin Safety Testing of 1 Mitopure Topical Product U... | NCT07517900

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

NCT07517900

Sponsor

Amazentis SA

Status

Completed

Last Update Posted

Jun 11, 2026Actual

Enrollment

40Actual

Phase

Not Applicable

Conditions

Healthy Adult

Interventions

Mitopure Topical Formula

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 20, 2026Actual

Primary Completion Date

May 4, 2026Actual

Completion Date

May 4, 2026Actual

First Submitted Date

Apr 2, 2026

First Submission Date that Met QC Criteria

Apr 2, 2026

First Posted Date

Apr 8, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 9, 2026

Last Update Posted Date

Jun 11, 2026Actual

Name	Class
Princeton Consumer Research	OTHER

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Label	Type	Description	Intervention Names
Mitopure Topical Formula	Experimental		Other: Mitopure Topical Formula

Name	Type	Description	Arm Group Labels	Other Names
Mitopure Topical Formula	Other	Topical skin serum containing Mitopure	Mitopure Topical Formula

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Product traits	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	2 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided