Healthy SkinCleanserNCT06956625
Cleansing Efficacy of Cosmetic Product
A study testing Topical cosmetic cleanser and Topical tap water in people with Healthy Skin, run by Amazentis SA at 1 site in Germany.
Trial summary
The aim of this study is to investigate the cleansing effect of one cosmetic product containing Mitopure against a particular matter model pollutant in comparison to an untreated control. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Skin
- What is being tested?
- Topical cosmetic cleanser and Topical tap water
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteGermany
- Study dates
- 8 May 2025to 9 May 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Written informed consent to participate in the study
- Willingness to actively participate in the study and to come to the scheduled visits
- Female and/or male
- From 18 to 70 years of age
- Healthy skin in the test area
- Skin type on Fitzpatrick scale: I, II or III
Who cannot join
- Female subjects: Pregnancy or lactation
- Drug addicts, alcoholics
- AIDS, HIV-positive or infectious hepatitis
- Conditions which exclude a participation or might influence the test reaction/evaluation
- Participation or being in the waiting period after participation in cosmetic and/or pharmaceutical studies pertaining to the test area
- Cancer not being diagnosed as cured and requiring chemotherapy, irradiation and/or hormonal treatment within the last 2 years
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- Active skin disease at the test area
- Wounds, moles, tattoos, scars, irritated skin, excessive hair growth, etc. at the test area that could influence the investigation
- Any topical medication at the test area within the last 4 weeks prior to the start of the study and during the study
- Documented allergies to cosmetic products and/or ingredients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cleansing Efficacy of Cosmetic Products - Particular Matter Model
The aim of this study is to investigate the cleansing effect of one cosmetic product containing Mitopure against a particular matter model pollutant in comparison to an untreated control.
- Conditions
- Healthy Skin
- Being tested
- Topical cosmetic cleanser, Topical tap water
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical cosmetic cleanserOther
After applying the model pollutant, the test area will be topically cleaned with the active cosmetic cleanser with Mitopure.
Topical tap waterOther
After applying the model pollutant, the test area will be topically cleaned with tap water (control).
| Study group | Role | What they receive |
|---|---|---|
| Cosmetic product | Experimental | Test area topically washed with cleanser containing Mitopure Receives: Other: Topical cosmetic cleanser |
| Tap water (control) | Other | Test area topically washed with tap water Receives: Other: Topical tap water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Luminosity (L)
Luminosity in test area assessed by HiRIS (High Resolution Imaging System) image analysis will be used to quantify cleaning efficacy.
Measured: Before pollutant application (t0), immediately after evaporation of the applied pollutant (t1), and 20 minutes after product rinse-off (t2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2025
- Study start8 May 2025
- Primary completion9 May 2025
- Study completion9 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SkinStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two test areas will be defined on both forearms. Area 1 will be located on the right forearm; Area 2 will be located on the left forearm. Treatments will be randomly and balanced assigned to the test areas.
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amazentis SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- SGS Proderm GmbH
- Responsible party
- Sponsor
- Investigators
- Dr Katrin Unbereit, Principal investigator, SGS Proderm GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06956625
- Sponsor's protocol ID
- 25.0054-60
- Acronym
- Cleanser
- Status last verified
- Jun 2025
- First submitted
- 23 Apr 2025
- Last updated
- 18 Jun 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 18 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cleansing Efficacy of Cosmetic Products - Particular Matter Model
- ClinicalTrials.gov ID
- NCT06956625
- Acronym / sponsor ID
- Cleanser / 25.0054-60
- Conditions
- Healthy Skin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Amazentis SAIndustry (pharma, biotech, devices)
- Collaborators
- SGS Proderm GmbH
- Study start
- 8 May 2025 (actual)
- Primary completion
- 9 May 2025 (actual)
- Study completion
- 9 May 2025 (actual)
- First posted
- 4 May 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 aim of this study is to investigate the cleansing effect of one cosmetic product containing Mitopure against a particular matter model pollutant in comparison to an untreated control.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two test areas will be defined on both forearms. Area 1 will be located on the right forearm; Area 2 will be located on the left forearm. Treatments will be randomly and balanced assigned to the test areas.
| Arm | Type | Receives |
|---|---|---|
| Cosmetic product | Experimental | Other: Topical cosmetic cleanserTest area topically washed with cleanser containing Mitopure |
| Tap water (control) | Other | Other: Topical tap waterTest area topically washed with tap water |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Written informed consent to participate in the study
- Willingness to actively participate in the study and to come to the scheduled visits
- Female and/or male
- From 18 to 70 years of age
- Healthy skin in the test area
Key exclusion criteria (10 listed)
- Female subjects: Pregnancy or lactation
- Drug addicts, alcoholics
- AIDS, HIV-positive or infectious hepatitis
- Conditions which exclude a participation or might influence the test reaction/evaluation
- Participation or being in the waiting period after participation in cosmetic and/or pharmaceutical studies pertaining to the test area
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 |
|---|---|---|
| Topical cosmetic cleanserAfter applying the model pollutant, the test area will be topically cleaned with the active cosmetic cleanser with Mitopure. | Other | Cosmetic product |
| Topical tap waterAfter applying the model pollutant, the test area will be topically cleaned with tap water (control). | Other | Tap water (control) |
Primary outcome
Luminosity (L)
Time frame: Before pollutant application (t0), immediately after evaporation of the applied pollutant (t1), and 20 minutes after product rinse-off (t2)
Luminosity in test area assessed by HiRIS (High Resolution Imaging System) image analysis will be used to quantify cleaning efficacy.
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 18 Jun 2025.
- 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.
Dr Katrin Unbereit principal investigator
SGS Proderm GmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Topical cosmetic cleanser and Topical tap water in people with Healthy Skin, run by Amazentis SA at 1 site in Germany.
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 6 inclusion and 10 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 18 Jun 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 Germany. 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?
Luminosity (L) (time frame: Before pollutant application (t0), immediately after evaporation of the applied pollutant (t1), and 20 minutes after product rinse-off (t2)). 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 18 Jun 2025.