Healthy SkinExfoliatorNCT07096466
Skin Cell Regeneration Efficacy of Cosmetic Product
A study testing DHA stain, No DHA stain and Cosmetic product application - forearm in people with Healthy Skin, run by Amazentis SA at 1 site in Germany.
Trial summary
The objective of the study is to investigate the effect of one cosmetic product (exfoliator) containing Mitopure on the skin cell regeneration as well as on the skin hydration and skin barrier function in comparison to an untreated control area on the volar forearms. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Skin
- What is being tested?
- DHA stain, No DHA stain and Cosmetic product application - forearm
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- 23 Jun 2025to 9 Jul 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 65 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 65 years of age
- Healthy skin in the test area
- Uniform skin color in the test area
- Fitzpatrick I-III
- Able to read and follow directions as outlined in the protocol
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
Show all 19Show fewer
- Insulin-dependent diabetes mellitus (type 1 and 2)
- Documented allergies to cosmetic products and/or ingredients,
- Documented allergies to plaster systems or tape adhesives
- Active skin disease at the test area like acute dermatitis, that requires actual topical medication on the test area and/or systemic drug treatment according to a physician
- Wounds, moles, tattoos, scars, irritated skin, excessive hair growth, etc. at the test area that could influence the investigation
- All kinds of beard (except a moustache) during the whole study
- Any topical medication at the test area within the last 3 days prior to the start of the study and throughout the entire course of the study
- Topical medication with anti-inflammatories, antihistamines within 1 week prior to the start of the study
- Topical medication with Immuno-suppressive medication within 2 weeks prior to the start of the study
- Systemic (oral) medication with Antibiotic (except penicillin) or anti-inflammatory steroids within 4 weeks prior to the start of the study and throughout the entire course of the study
- Systemic (oral) medication with anti-inflammatory non-steroids within 2 weeks prior to the start of the study and throughout the entire course of the study
- Phototherapy within 4 weeks prior to the start of the study and throughout the entire course of the study
- Systemic (oral) medication with retinoids within 6 months prior to the start of the study and throughout the entire course of the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: CELL REGENERATION EFFICACY
The objective of the study is to investigate the effect of one cosmetic product (exfoliator) containing Mitopure on the skin cell regeneration as well as on the skin hydration and skin barrier function in comparison to an untreated control area on the volar forearms.
- Conditions
- Healthy Skin
- Being tested
- DHA stain, No DHA stain, Cosmetic product application - forearm, No cosmetic product application - forearm, Cosmetic products application - face
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DHA stainOther
On day 1, the volar forearm test area will undergo DHA staining (250μl of 10% DHA solution applied under occlusion with Finn Chambers for 8 hours)
No DHA stainOther
On day 1, the volar forearm test area will not undergo DHA staining.
Cosmetic product application - forearmOther
The cosmetic product will be applied twice daily for two weeks to the volar forearm test area.
No cosmetic product application - forearmOther
The cosmetic product will not be applied for two weeks to the volar forearm test area.
Cosmetic products application - faceOther
For two weeks on the face (excluding eye area), a cleansing cosmetic product containing Mitopure will be applied twice daily, and the cosmetic test product (that is used on forearms) will be applied once daily.
| Study group | Role | What they receive |
|---|---|---|
| Untreated, stained forearm | Experimental | On day 1, the volar forearm test area will undergo DHA staining (250μl of 10% DHA solution applied under occlusion with Finn Chambers for 8 hours). The cosmetic product will not be applied for two weeks to the volar forearm test area. Receives: Other: DHA stain; Other: No cosmetic product application - forearm |
| Treated, stained forearm | Experimental | On day 1, the volar forearm test area will undergo DHA staining (250μl of 10% DHA solution applied under occlusion with Finn Chambers for 8 hours). The cosmetic product will then be applied twice daily for two weeks to the volar forearm test area. Receives: Other: DHA stain; Other: Cosmetic product application - forearm |
| Untreated, unstained forearm | Experimental | On day 1, the volar forearm test area will not undergo DHA staining. The cosmetic product will not be applied for two weeks to the volar forearm test area. Receives: Other: No DHA stain; Other: No cosmetic product application - forearm |
| Treated, unstained forearm | Experimental | On day 1, the volar forearm test area will not undergo DHA staining. The cosmetic product will then be applied twice daily for two weeks to the volar forearm test area. Receives: Other: No DHA stain; Other: Cosmetic product application - forearm |
| Facial treatment | Experimental | For two weeks on the face (excluding eye area), a cleansing cosmetic product containing Mitopure will be applied twice daily, and the cosmetic test product (that is used on forearms) will be applied once daily. Receives: Other: Cosmetic products application - face |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin cell regeneration quantified by change in skin color measured by Chromameter (unit of measure: Individual Typological Angle; ITA°)
Skin cell regeneration is quantified by the change in skin colour. Skin colour is measured with the Chromameter instrument (skin colour unit of measure: Individual Typological Angle [ITA°]). Therefore, skin cell regeneration is measured by the change in ITA°, such that a larger positive change in ITA° represents improved skin cell regeneration. Skin cell regeneration will be calculated 4, 8, 11, and 14 days after baseline.
Measured: 14 days
Secondary outcomes (3)
Skin hydration
Change from baseline in skin hydration (assessed on skin capacitance by Corneometer) after 14 days.
Measured: 14 days
Skin barrier function
Change from baseline in skin barrier function (assessed on Transepidermal water loss (TEWL) by Tewameter [g/(m²h)]) after 14 days.
Measured: 14 days
Product traits
Subjective evaluation of product traits assessed via questionnaire after 14 days. 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; 1 = Rather agree; 2 = Fully agree
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2025
- Study start23 Jun 2025
- Primary completion9 Jul 2025
- Study completion9 Jul 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
- On each volar forearm two test areas (each sized 3 cm x 3 cm) will be defined. Test area 1 will denote the lower right, 2 the upper right forearm. Test areas 3 and 4 on left forearm will be allocated accordingly. Each forearm test area will undergo one of four treatments (stained or unstained with DHA; and treated or untreated with cosmetic product) so all four treatments are experienced by every participant. Overall, the four treatment conditions (one treatment per test area) will be: A) Untreated with cosmetic product, stained with DHA (negative control) B) Treated with cosmetic product, stained with DHA C) Untreated with cosmetic product, unstained (negative control) D) Treated with cosmetic product, unstained Treatments will be randomly and balanced assigned to the four volar forearm test areas. E) All participants will also apply two cosmetic products to the facial area.
- Masking
- None (open label)
- Enrolment
- 30 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
- NCT07096466
- Sponsor's protocol ID
- 25.0055-25
- Acronym
- Exfoliator
- Status last verified
- Jul 2025
- First submitted
- 18 Jul 2025
- Last updated
- 31 Jul 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 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CELL REGENERATION EFFICACY
- ClinicalTrials.gov ID
- NCT07096466
- Acronym / sponsor ID
- Exfoliator / 25.0055-25
- Conditions
- Healthy Skin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Amazentis SAIndustry (pharma, biotech, devices)
- Collaborators
- SGS Proderm GmbH
- Study start
- 23 Jun 2025 (actual)
- Primary completion
- 9 Jul 2025 (actual)
- Study completion
- 9 Jul 2025 (actual)
- First posted
- 31 Jul 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 the study is to investigate the effect of one cosmetic product (exfoliator) containing Mitopure on the skin cell regeneration as well as on the skin hydration and skin barrier function in comparison to an untreated control area on the volar forearms.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- On each volar forearm two test areas (each sized 3 cm x 3 cm) will be defined. Test area 1 will denote the lower right, 2 the upper right forearm. Test areas 3 and 4 on left forearm will be allocated accordingly. Each forearm test area will undergo one of four treatments (stained or unstained with DHA; and treated or untreated with cosmetic product) so all four treatments are experienced by every participant. Overall, the four treatment conditions (one treatment per test area) will be: A) Untreated with cosmetic product, stained with DHA (negative control) B) Treated with cosmetic product, stained with DHA C) Untreated with cosmetic product, unstained (negative control) D) Treated with cosmetic product, unstained Treatments will be randomly and balanced assigned to the four volar forearm test areas. E) All participants will also apply two cosmetic products to the facial area.
| Arm | Type | Receives |
|---|---|---|
| Untreated, stained forearm | Experimental | Other: DHA stain, Other: No cosmetic product application - forearmOn day 1, the volar forearm test area will undergo DHA staining (250μl of 10% DHA solution applied under occlusion with Finn Chambers for 8 hours). The cosmetic product will not be applied for two weeks to the volar forearm test area. |
| Treated, stained forearm | Experimental | Other: DHA stain, Other: Cosmetic product application - forearmOn day 1, the volar forearm test area will undergo DHA staining (250μl of 10% DHA solution applied under occlusion with Finn Chambers for 8 hours). The cosmetic product will then be applied twice daily for two weeks to the volar forearm test area. |
| Untreated, unstained forearm | Experimental | Other: No DHA stain, Other: No cosmetic product application - forearmOn day 1, the volar forearm test area will not undergo DHA staining. The cosmetic product will not be applied for two weeks to the volar forearm test area. |
| Treated, unstained forearm | Experimental | Other: No DHA stain, Other: Cosmetic product application - forearmOn day 1, the volar forearm test area will not undergo DHA staining. The cosmetic product will then be applied twice daily for two weeks to the volar forearm test area. |
| Facial treatment | Experimental | Other: Cosmetic products application - faceFor two weeks on the face (excluding eye area), a cleansing cosmetic product containing Mitopure will be applied twice daily, and the cosmetic test product (that is used on forearms) will be applied once daily. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 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 65 years of age
- Healthy skin in the test area
Key exclusion criteria (19 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 |
|---|---|---|
| DHA stainOn day 1, the volar forearm test area will undergo DHA staining (250μl of 10% DHA solution applied under occlusion with Finn Chambers for 8 hours) | Other | Treated, stained forearm, Untreated, stained forearm |
| No DHA stainOn day 1, the volar forearm test area will not undergo DHA staining. | Other | Treated, unstained forearm, Untreated, unstained forearm |
| Cosmetic product application - forearmThe cosmetic product will be applied twice daily for two weeks to the volar forearm test area. | Other | Treated, stained forearm, Treated, unstained forearm |
| No cosmetic product application - forearmThe cosmetic product will not be applied for two weeks to the volar forearm test area. | Other | Untreated, stained forearm, Untreated, unstained forearm |
| Cosmetic products application - faceFor two weeks on the face (excluding eye area), a cleansing cosmetic product containing Mitopure will be applied twice daily, and the cosmetic test product (that is used on forearms) will be applied once daily. | Other | Facial treatment |
Primary outcome
Skin cell regeneration quantified by change in skin color measured by Chromameter (unit of measure: Individual Typological Angle; ITA°)
Time frame: 14 days
Skin cell regeneration is quantified by the change in skin colour. Skin colour is measured with the Chromameter instrument (skin colour unit of measure: Individual Typological Angle [ITA°]). Therefore, skin cell regeneration is measured by the change in ITA°, such that a larger positive change in ITA° represents improved skin cell regeneration. Skin cell regeneration will be calculated 4, 8, 11, and 14 days after baseline.
3 secondary outcomes
Skin hydration
Time frame: 14 days
Skin barrier function
Time frame: 14 days
Product traits
Time frame: 14 days
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 31 Jul 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 DHA stain, No DHA stain and Cosmetic product application - forearm 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 8 inclusion and 19 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 31 Jul 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?
Skin cell regeneration quantified by change in skin color measured by Chromameter (unit of measure: Individual Typological Angle; ITA°) (time frame: 14 days). 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 31 Jul 2025.