Healthy AdultSIU-1NCT07517900
Human Skin Safety Testing of 1 Mitopure Topical Product Using a Clinical Safety in Use Study in Healthy Volunteers
A study testing Mitopure Topical Formula in people with Healthy Adult, run by Amazentis SA at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult
- What is being tested?
- Mitopure Topical Formula
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 20 Apr 2026to 4 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Healthy Adult
- Being tested
- Mitopure Topical Formula
- Keywords
- Safety In Use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mitopure Topical FormulaOther
Topical skin serum containing Mitopure
| Study group | Role | What they receive |
|---|---|---|
| Mitopure Topical Formula | Experimental | Not described Receives: Other: Mitopure Topical Formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin Irritation
Visual evaluation by an expert clinical grader at Baseline and Week 2 for skin condition.
Measured: 2 weeks
Secondary outcomes (1)
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
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2026
- Study start20 Apr 2026
- Primary completion4 May 2026
- Study completion4 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy AdultStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amazentis SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Princeton Consumer Research
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07517900
- Sponsor's protocol ID
- ASASIU1M
- Acronym
- SIU-1
- Status last verified
- Jun 2026
- First submitted
- 2 Apr 2026
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Safety in Use Study of 30 Healthy Volunteers to Investigate the Safety of 1 Test Article Following Repeated Applications
- ClinicalTrials.gov ID
- NCT07517900
- Acronym / sponsor ID
- SIU-1 / ASASIU1M
- Conditions
- Healthy Adult
- Keywords
- Safety In Use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Amazentis SAIndustry (pharma, biotech, devices)
- Collaborators
- Princeton Consumer Research
- Study start
- 20 Apr 2026 (actual)
- Primary completion
- 4 May 2026 (actual)
- Study completion
- 4 May 2026 (actual)
- First posted
- 8 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mitopure Topical Formula | Experimental | Other: Mitopure Topical Formula |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mitopure Topical FormulaTopical skin serum containing Mitopure | Other | Mitopure Topical Formula |
Primary outcome
Skin Irritation
Time frame: 2 weeks
Visual evaluation by an expert clinical grader at Baseline and Week 2 for skin condition.
1 secondary outcome
Product traits
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mitopure Topical Formula in people with Healthy Adult, run by Amazentis SA at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skin Irritation (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026.