Irritation/IrritantGLOW-Safety-2NCT06884215
Human Skin Safety Testing of Mitopure Topical Products Using a Human Repeat Insult Patch Test (HRIPT) in Healthy Volunteers
A study testing Mitopure Topical Formula 3 and Mitopure Topical Formula 4 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 multiple topically applied test articles (containing different concentrations of Mitopure), in a shared panel of healthy volunteers by means of repeated cutaneous patch applications under occlusion based on the modified Draize… 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 3 and Mitopure Topical Formula 4
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 17 Mar 2025to 28 Apr 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 Test Articles Following Repeated Cutaneous Patch Applications
The objective of this study is to investigate the irritation and sensitization potential of multiple topically applied test articles (containing different concentrations of 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 3, Mitopure Topical Formula 4
- Keywords
- HRIPT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mitopure Topical Formula 3Other
Topical skin cream containing Mitopure
Mitopure Topical Formula 4Other
Topical skin cream containing Mitopure
| Study group | Role | What they receive |
|---|---|---|
| Mitopure Topical Formula | Experimental | Not described Receives: Other: Mitopure Topical Formula 3; Other: Mitopure Topical Formula 4 |
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 posted19 Mar 2025
- Study start17 Mar 2025
- Primary completion28 Apr 2025
- Study completion28 Apr 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
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amazentis SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Princeton Research Corporation
- Responsible party
- Sponsor
- Investigators
- Anurag Singh, MD, PhD, Study director, Amazentis SA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06884215
- Sponsor's protocol ID
- ASARIP2M
- Acronym
- GLOW-Safety-2
- Status last verified
- May 2025
- First submitted
- 13 Mar 2025
- Last updated
- 21 May 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 21 May 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 Test Articles Following Repeated Cutaneous Patch Applications
- ClinicalTrials.gov ID
- NCT06884215
- Acronym / sponsor ID
- GLOW-Safety-2 / ASARIP2M
- Conditions
- Irritation/Irritant, Sensitisation
- Keywords
- HRIPT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Amazentis SAIndustry (pharma, biotech, devices)
- Collaborators
- Princeton Research Corporation
- Study start
- 17 Mar 2025 (actual)
- Primary completion
- 28 Apr 2025 (actual)
- Study completion
- 28 Apr 2025 (actual)
- First posted
- 19 Mar 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 multiple topically applied test articles (containing different concentrations of 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 3, Other: Mitopure Topical Formula 4 |
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 3Topical skin cream containing Mitopure | Other | Mitopure Topical Formula |
| Mitopure Topical Formula 4Topical skin cream 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 21 May 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.
Anurag Singh, MD, PhD study director
Amazentis SA
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 3 and Mitopure Topical Formula 4 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 21 May 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 21 May 2025.