Irritation/IrritantGLOW-Safety-3NCT07100912
Human Skin Safety Testing of 6 Mitopure Topical Products Using a Human Repeat Insult Patch Test (HRIPT) in Healthy Volunteers
A study testing Mitopure Topical Formula 5, Mitopure Topical Formula 6 and Mitopure Topical Formula 7 in people with Irritation/Irritant and Sensitisation, run by Amazentis SA at 1 site in United Kingdom.
Trial summary
The objective of this study is to investigate the irritation and sensitization potential of 6 different topically applied test articles containing Mitopure in a shared panel of healthy volunteers by means of repeated cutaneous patch applications under occlusion based on the modified Draize method Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Irritation/Irritant, Sensitisation
- What is being tested?
- Mitopure Topical Formula 5, Mitopure Topical Formula 6 and Mitopure Topical Formula 7
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 113 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 18 Aug 2025to 26 Sep 2025
- 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 males or females,18 years of age or older (50% with sensitive skin).
- Completed written informed consent.
- Female subject agrees to use an acceptable method of birth control (e.g. abstinence, condoms, hormonal birth control, IUD, tubal ligation, hysterectomy, bilateral oophorectomy, hysterectomy, post-menopausal for at least one year or male partner vasectomy).
Who cannot join
- Pregnancy or lactation.
- Participation in a repeat insult patch test (RIPT) or follow-up work within the last month.
- Current treatment by a physician for allergy unless physician consulted by Investigator and participation approved.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Modified Draize Repeat Insult Patch Test in a Shared Panel of 100 Healthy Volunteers to Investigate the Irritation and Sensitization Potential of 6 Test Articles Following Repeated Cutaneous Patch Applications
The objective of this study is to investigate the irritation and sensitization potential of 6 different topically applied test articles containing Mitopure in a shared panel of healthy volunteers by means of repeated cutaneous patch applications under occlusion based on the modified Draize method
- Conditions
- Irritation/Irritant, Sensitisation
- Being tested
- Mitopure Topical Formula 5, Mitopure Topical Formula 6, Mitopure Topical Formula 7, Mitopure Topical Formula 8, Mitopure Topical Formula 9
- Keywords
- HRIPT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mitopure Topical Formula 5Other
Topical skin cream containing Mitopure
Mitopure Topical Formula 6Other
Topical skin cream containing Mitopure
Mitopure Topical Formula 7Other
Topical skin cream containing Mitopure
Mitopure Topical Formula 8Other
Topical skin serum containing Mitopure
Mitopure Topical Formula 9Other
Topical skin exfoliator containing Mitopure
Mitopure Topical Formula 10Other
Topical skin cleanser containing Mitopure
| Study group | Role | What they receive |
|---|---|---|
| Mitopure Topical Formula | Experimental | Not described Receives: Other: Mitopure Topical Formula 5; Other: Mitopure Topical Formula 6; Other: Mitopure Topical Formula 7; Other: Mitopure Topical Formula 8; Other: Mitopure Topical Formula 9; Other: Mitopure Topical Formula 10 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin safety as assessed by the number of adverse events of skin irritation and sensitization during human repeat insult patch testing (HRIPT)
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2025
- Study start18 Aug 2025
- Primary completion26 Sep 2025
- Study completion26 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritation/IrritantStudies 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
- 113 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
- NCT07100912
- Sponsor's protocol ID
- ASARIP3M
- Acronym
- GLOW-Safety-3
- Status last verified
- Nov 2025
- First submitted
- 28 Jul 2025
- Last updated
- 17 Nov 2025
- 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 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Modified Draize Repeat Insult Patch Test in a Shared Panel of 100 Healthy Volunteers to Investigate the Irritation and Sensitization Potential of 6 Test Articles Following Repeated Cutaneous Patch Applications
- ClinicalTrials.gov ID
- NCT07100912
- Acronym / sponsor ID
- GLOW-Safety-3 / ASARIP3M
- Conditions
- Irritation/Irritant, Sensitisation
- Keywords
- HRIPT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- Amazentis SAIndustry (pharma, biotech, devices)
- Collaborators
- Princeton Consumer Research
- Study start
- 18 Aug 2025 (actual)
- Primary completion
- 26 Sep 2025 (actual)
- Study completion
- 26 Sep 2025 (actual)
- First posted
- 3 Aug 2025 (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 irritation and sensitization potential of 6 different topically applied test articles containing Mitopure in a shared panel of healthy volunteers by means of repeated cutaneous patch applications under occlusion based on the modified Draize method
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 5, Other: Mitopure Topical Formula 6, Other: Mitopure Topical Formula 7, Other: Mitopure Topical Formula 8, Other: Mitopure Topical Formula 9, Other: Mitopure Topical Formula 10 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy males or females,18 years of age or older (50% with sensitive skin).
- Completed written informed consent.
- Female subject agrees to use an acceptable method of birth control (e.g. abstinence, condoms, hormonal birth control, IUD, tubal ligation, hysterectomy, bilateral oophorectomy, hysterectomy, post-menopausal for at least one year or male partner vasectomy).
Key exclusion criteria (3 listed)
- Pregnancy or lactation.
- Participation in a repeat insult patch test (RIPT) or follow-up work within the last month.
- Current treatment by a physician for allergy unless physician consulted by Investigator and participation approved.
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 Formula 5Topical skin cream containing Mitopure | Other | Mitopure Topical Formula |
| Mitopure Topical Formula 6Topical skin cream containing Mitopure | Other | Mitopure Topical Formula |
| Mitopure Topical Formula 7Topical skin cream containing Mitopure | Other | Mitopure Topical Formula |
| Mitopure Topical Formula 8Topical skin serum containing Mitopure | Other | Mitopure Topical Formula |
| Mitopure Topical Formula 9Topical skin exfoliator containing Mitopure | Other | Mitopure Topical Formula |
| Mitopure Topical Formula 10Topical skin cleanser containing Mitopure | Other | Mitopure Topical Formula |
Primary outcome
Skin safety as assessed by the number of adverse events of skin irritation and sensitization during human repeat insult patch testing (HRIPT)
Time frame: 6 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 17 Nov 2025.
- Individual participant dataSharing planned: No
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 5, Mitopure Topical Formula 6 and Mitopure Topical Formula 7 in people with Irritation/Irritant and Sensitisation, 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 3 inclusion and 3 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 17 Nov 2025. 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 safety as assessed by the number of adverse events of skin irritation and sensitization during human repeat insult patch testing (HRIPT) (time frame: 6 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 17 Nov 2025.