Skin AgingNCT05300984
Evaluation of the Anti-aging Efficacy of a Novel Skin Health Product
A study testing Topical Cream with 0.5% Active and Topical Cream with 1% Active in people with Skin Aging, run by Amazentis SA at 1 site in Germany.
Trial summary
The aim of this study is to investigate the effect of cosmetic products with two different concentrations of the active on skin aging and in acting on the mitochondrial health of skin in comparison to a placebo product. Read more about this study
- Who is it for?
- Ages 50 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Skin Aging
- What is being tested?
- Topical Cream with 0.5% Active and Topical Cream with 1% Active
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteGermany
- Study dates
- 15 Mar 2022to 16 May 2022
- 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 50 to 75 years
- Women only
- 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
- From 50 to 75 years of age
- Visible wrinkle in the face (grade 3 to 6 according to proderm scale) see Appendix 2
- Healthy skin in the test areas
- Vaccination of tetanus within the last 10 years (for biopsy sub group)
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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- Diabetes mellitus (type 1 and 2)
- One of the following illnesses with reduced physical capability/fitness: asthma (symptom-free allergic asthma is not an exclusion criterion), hypertension, cardiovascular diseases
- Documented allergies to cosmetic products and/or ingredients, skin care and/or skin cleansing products
- Intolerability against adhesive dressing (e.g. acrylate)
- Active skin disease at the test area
- Regular use of tanning beds
- 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 3 days prior to the start of the study
- Medical treatment for wrinkle reduction (e.g. peeling with vitamin A or fruit acids) on the face within the last 2 weeks prior to the start of the study
- Systemic therapy with immuno-suppressive drugs (e.g. corticosteroids) and/or antihistamines (e.g. antiallergics) within the last 7 days prior to the start of the study
- Systemic therapy with anti-phlogistic agents or analgetics (e.g. diclophenac), except for minor pain relief medicine like paracetamol within the last 3 days prior to the start of the study
- Therapy with antibiotics within the last 2 weeks prior to the start of the study
- Regular medication with anti-coagulating drugs like Aspirin®, Macumar®, etc. (e.g. for thrombosis prophylaxis) within up to 15 days prior to the taking of the biopsies
- Past cosmetic surgery procedure in the test area (e.g. laser, facelift)
- History of complications at wound healing (e.g. keloids, hypertrophic scars or contracture scar)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Anti-aging Efficacy of a Novel Cosmetic Product
The aim of this study is to investigate the effect of cosmetic products with two different concentrations of the active on skin aging and in acting on the mitochondrial health of skin in comparison to a placebo product.
- Conditions
- Skin Aging
- Being tested
- Topical Placebo Cream, Topical Cream with 0.5% Active, Topical Cream with 1% Active
- Keywords
- Mitochondria, Aging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical Placebo CreamOther
cosmetic cream to be applied topically on face and forearms twice/daily using split/face design
Topical Cream with 0.5% ActiveOther
cosmetic cream to be applied topically on face and forearms twice/daily using split/face design
Topical Cream with 1% ActiveOther
cosmetic cream to be applied topically on face and forearms twice/daily using split/face design
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Not described Receives: Other: Topical Placebo Cream; Other: Topical Cream with 0.5% Active |
| Group 2 | Experimental | Not described Receives: Other: Topical Placebo Cream; Other: Topical Cream with 1% Active |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in skin mitochondrial health and biological age (assessed on skin biopsies) after 8 weeks
Measured: 8 weeks
Change from baseline in skin barrier function (assessed on transepidermal waterloss by Tewameter [g/(m²h)]) after 8-weeks
Measured: 8 weeks
Secondary outcomes (8)
Change from baseline in skin barrier function (assessed on transepidermal waterloss by Tewameter [g/(m²h)]) after 2-weeks
Measured: 2-weeks
Change from baseline in skin hydration (assessed on skin capacitance by Corneometer [a.u.]) after 2 and 8 weeks
Measured: 8 weeks
Change from baseline in pigmentation (assessed on skin color by Spectrophotometer) after 2 and 8 weeks
Measured: 8 weeks
Change from baseline in skin firmness by Cutometer [mm] after 2 and 8 weeks
Measured: 8 weeks
Change from baseline in skin elasticity by Cutometer after 2 and 8 weeks
Measured: 8 weeks
Change from baseline in skin layer thickness and undulation index of DEJ (assessed on Line field confocal Optical Coherence Tomography Image analysis) after 8 weeks for both groups or after 2 and 8 weeks
Measured: 8 weeks
Change from baseline for wrinkles and fine lines (assessed on Colorface Image analysis) after 2 and 8 weeks
Measured: 8 weeks
Subjective Evaluation of product traits assessed via questionnaire after 2 and 8 weeks
Measured: 2 and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2022
- Study start15 Mar 2022
- Primary completion10 May 2022
- Study completion16 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin AgingStudies 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
- Split face/arm design
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amazentis SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- proDERM GmbH
- Responsible party
- Sponsor
- Investigators
- Prof. Dr. med. Klaus-Peter Wilhelm, Dermatologist, MD, Study chair, proDERM GmbHDr. rer. nat. Sabrina Laing, MD, Principal investigator, proDERM GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05300984
- Sponsor's protocol ID
- 22.01.AMZ
- Other IDs
- 22.0052-23
- Status last verified
- Apr 2023
- First submitted
- 19 Mar 2022
- Last updated
- 6 Apr 2023
- 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 6 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Anti-aging Efficacy of a Novel Cosmetic Product
- ClinicalTrials.gov ID
- NCT05300984
- Acronym / sponsor ID
- 22.01.AMZ
- Conditions
- Skin Aging
- Keywords
- Mitochondria, Aging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Amazentis SAIndustry (pharma, biotech, devices)
- Collaborators
- proDERM GmbH
- Study start
- 15 Mar 2022 (actual)
- Primary completion
- 10 May 2022 (actual)
- Study completion
- 16 May 2022 (actual)
- First posted
- 29 Mar 2022 (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 effect of cosmetic products with two different concentrations of the active on skin aging and in acting on the mitochondrial health of skin in comparison to a placebo product.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Split face/arm design
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Other: Topical Placebo Cream, Other: Topical Cream with 0.5% Active |
| Group 2 | Experimental | Other: Topical Placebo Cream, Other: Topical Cream with 1% Active |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Written Informed Consent to participate in the study
- Willingness to actively participate in the study and to come to the scheduled visits
- Female
- From 50 to 75 years of age
- Visible wrinkle in the face (grade 3 to 6 according to proderm scale) see Appendix 2
Key exclusion criteria (21 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 Placebo Creamcosmetic cream to be applied topically on face and forearms twice/daily using split/face design | Other | Group 1, Group 2 |
| Topical Cream with 0.5% Activecosmetic cream to be applied topically on face and forearms twice/daily using split/face design | Other | Group 1 |
| Topical Cream with 1% Activecosmetic cream to be applied topically on face and forearms twice/daily using split/face design | Other | Group 2 |
Primary outcome
Change from baseline in skin mitochondrial health and biological age (assessed on skin biopsies) after 8 weeks
Time frame: 8 weeks
Change from baseline in skin barrier function (assessed on transepidermal waterloss by Tewameter [g/(m²h)]) after 8-weeks
Time frame: 8 weeks
8 secondary outcomes
Change from baseline in skin barrier function (assessed on transepidermal waterloss by Tewameter [g/(m²h)]) after 2-weeks
Time frame: 2-weeks
Change from baseline in skin hydration (assessed on skin capacitance by Corneometer [a.u.]) after 2 and 8 weeks
Time frame: 8 weeks
Change from baseline in pigmentation (assessed on skin color by Spectrophotometer) after 2 and 8 weeks
Time frame: 8 weeks
Change from baseline in skin firmness by Cutometer [mm] after 2 and 8 weeks
Time frame: 8 weeks
Change from baseline in skin elasticity by Cutometer after 2 and 8 weeks
Time frame: 8 weeks
Change from baseline in skin layer thickness and undulation index of DEJ (assessed on Line field confocal Optical Coherence Tomography Image analysis) after 8 weeks for both groups or after 2 and 8 weeks
Time frame: 8 weeks
Change from baseline for wrinkles and fine lines (assessed on Colorface Image analysis) after 2 and 8 weeks
Time frame: 8 weeks
Subjective Evaluation of product traits assessed via questionnaire after 2 and 8 weeks
Time frame: 2 and 8 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 6 Apr 2023.
- 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.
Prof. Dr. med. Klaus-Peter Wilhelm, Dermatologist, MD study chair
proDERM GmbH
Dr. rer. nat. Sabrina Laing, MD principal investigator
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 Cream with 0.5% Active and Topical Cream with 1% Active in people with Skin Aging, 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 7 inclusion and 21 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 6 Apr 2023. 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?
Change from baseline in skin mitochondrial health and biological age (assessed on skin biopsies) after 8 weeks (time frame: 8 weeks). The study lists 2 primary outcomes in all. 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 6 Apr 2023.