Anti-AgingNCT05473832
Evaluation of the Anti-aging Efficacy of Four Skin Health Products
A study testing Day Cream cosmetic product compared to untreated side, Night cream cosmetic product compared to untreated side and Eye cream cosmetic product compared to untreated side in people with Anti-Aging and Skin Aging, run by Amazentis SA at 1 site in Germany.
Trial summary
The purpose of this study is to assess the anti-wrinkle and anti-aging efficacy of four different cosmetic products compared to an untreated control (split-face study design) Read more about this study
- Who is it for?
- Ages 40 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Anti-Aging, Skin Aging
- What is being tested?
- Day Cream cosmetic product compared to untreated side, Night cream cosmetic product compared to untreated side and Eye cream cosmetic product compared to untreated side
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteGermany
- Study dates
- 13 Jul 2022to 17 Oct 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 40 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 male
- From 40 to 65 years of age
- BMI < 30 kg/m2
- Healthy skin in the test areas
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- Uniform skin color and no erythema or dark pigmentation in the test area
- Visible wrinkle in the face (grade 3 to 6 according to proderm scale) see Appendix 2
- Ethnicity: at least one Black, Asian and Hispanic subject per study 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
- Active skin disease at the test area
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- Documented allergies to face/eye care products
- Diabetes mellitus
- Cancer not being diagnosed as cured and requiring chemotherapy, irradiation and/or hormonal treatment within the last 2 years One of the following illnesses with reduced physical capability/fitness: asthma (symptom-free allergic asthma is not an exclusion criterion), hypertension (if not adjusted with medication), cardiovascular diseases
- Epilepsy
- Wounds, moles, tattoos, scars, irritated skin, excessive hair growth, freckles, etc. at the test area that could influence the investigation
- Sun-tanned skin (important for the subgroup of subjects planned for Raman measurements)
- Regular use of tanning beds
- Any topical medication at the test area within the last 7 days prior to the start of the study
- Systemic therapy with immuno-suppressive drugs (e.g. corticosteroids) and/or antihistamines (e.g. antiallergics) and/or within the last 7 days prior to the start of the study
- Past cosmetic surgery procedure in the test area (e.g. laser, facelift)
- Cosmetic surgery procedure in the test area, e.g. IPL (Intensed Pulsed Light), botox, chemical peel, dermabrasion within the last 2 years prior to the start of the study and/or throughout the entire course 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Anti-aging Efficacy of Four Cosmetic Products
The purpose of this study is to assess the anti-wrinkle and anti-aging efficacy of four different cosmetic products compared to an untreated control (split-face study design)
- Conditions
- Anti-Aging, Skin Aging
- Being tested
- Day Cream cosmetic product compared to untreated side, Night cream cosmetic product compared to untreated side, Eye cream cosmetic product compared to untreated side, Serum cosmetic product compared to untreated side
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Day Cream cosmetic product compared to untreated sideOther
Applied once daily in the morning
Night cream cosmetic product compared to untreated sideOther
Applied once daily in the evening
Eye cream cosmetic product compared to untreated sideOther
Applied twice daily in the morning and in the evening around the eye area
Serum cosmetic product compared to untreated sideOther
Applied twice daily in the morning and in the evening
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Not described Receives: Other: Day Cream cosmetic product compared to untreated side |
| Group 2 | Experimental | Not described Receives: Other: Night cream cosmetic product compared to untreated side |
| Group 3 | Experimental | Not described Receives: Other: Eye cream cosmetic product compared to untreated side |
| Group 4 | Experimental | Not described Receives: Other: Serum cosmetic product compared to untreated side |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anti-wrinkle efficacy will be assessed in the periorbital regions wrinkles using DermaTOP. Parameters measured: Rz and Ra, representing mainly the rough structure (Rz) or the finer skin structure (Ra).
Measured: 8-weeks
Secondary outcomes (8)
Change from baseline in skin firmness by Cutometer [mm] after 2, 4 and 8 weeks
Measured: 8-weeks
Change from baseline in skin elasticity by Cutometer after 2, 4 and 8 weeks
Measured: 8-weeks
Change from baseline in skin hydration (assessed on skin capacitance by Corneometer [a.u.]) after 2, 4 and 8 weeks
Measured: 8-weeks
Change from baseline in skin barrier function (assessed on transepidermal waterloss by Tewameter [g/(m²h)]) after 2, 4, 8-weeks
Measured: 8-weeks
Change from baseline in ceramides by Raman Spectroscopy [a.u.] on a subgroup of n=12 subjects per test product group after 2, 4 and 8 weeks
Measured: 8-weeks
Change in Image grading (Photodocumentation via USR-Clip) for skin radiance (3 trained graders will rank each pair of images in a blinded fashion) after 2, 4 and 8 weeks
Measured: 8-weeks
Change in wrinkle scores (Photodocumentation via USR-Clip) for anti-wrinkle efficacy (3 trained graders will rank each pair of images at the area of the crow feet's in a blinded manner)
Measured: 8-weeks
Subjective Evaluation of product traits assessed via questionnaire after 2, 4 and 8 weeks
Measured: 8-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2022
- Study start13 Jul 2022
- Primary completion30 Sep 2022
- Study completion17 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anti-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
- Masking
- None (open label)
- Enrolment
- 144 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, MD, Study chair, proDERM GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05473832
- Sponsor's protocol ID
- 22.0229-39
- Status last verified
- Apr 2023
- First submitted
- 18 Jul 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 Four Cosmetic Products
- ClinicalTrials.gov ID
- NCT05473832
- Acronym / sponsor ID
- 22.0229-39
- Conditions
- Anti-Aging, Skin Aging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Amazentis SAIndustry (pharma, biotech, devices)
- Collaborators
- proDERM GmbH
- Study start
- 13 Jul 2022 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 17 Oct 2022 (actual)
- First posted
- 26 Jul 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 purpose of this study is to assess the anti-wrinkle and anti-aging efficacy of four different cosmetic products compared to an untreated control (split-face study design)
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Other: Day Cream cosmetic product compared to untreated side |
| Group 2 | Experimental | Other: Night cream cosmetic product compared to untreated side |
| Group 3 | Experimental | Other: Eye cream cosmetic product compared to untreated side |
| Group 4 | Experimental | Other: Serum cosmetic product compared to untreated side |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 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 male
- From 40 to 65 years of age
- BMI < 30 kg/m2
Key exclusion criteria (18 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 |
|---|---|---|
| Day Cream cosmetic product compared to untreated sideApplied once daily in the morning | Other | Group 1 |
| Night cream cosmetic product compared to untreated sideApplied once daily in the evening | Other | Group 2 |
| Eye cream cosmetic product compared to untreated sideApplied twice daily in the morning and in the evening around the eye area | Other | Group 3 |
| Serum cosmetic product compared to untreated sideApplied twice daily in the morning and in the evening | Other | Group 4 |
Primary outcome
Anti-wrinkle efficacy will be assessed in the periorbital regions wrinkles using DermaTOP. Parameters measured: Rz and Ra, representing mainly the rough structure (Rz) or the finer skin structure (Ra).
Time frame: 8-weeks
8 secondary outcomes
Change from baseline in skin firmness by Cutometer [mm] after 2, 4 and 8 weeks
Time frame: 8-weeks
Change from baseline in skin elasticity by Cutometer after 2, 4 and 8 weeks
Time frame: 8-weeks
Change from baseline in skin hydration (assessed on skin capacitance by Corneometer [a.u.]) after 2, 4 and 8 weeks
Time frame: 8-weeks
Change from baseline in skin barrier function (assessed on transepidermal waterloss by Tewameter [g/(m²h)]) after 2, 4, 8-weeks
Time frame: 8-weeks
Change from baseline in ceramides by Raman Spectroscopy [a.u.] on a subgroup of n=12 subjects per test product group after 2, 4 and 8 weeks
Time frame: 8-weeks
Change in Image grading (Photodocumentation via USR-Clip) for skin radiance (3 trained graders will rank each pair of images in a blinded fashion) after 2, 4 and 8 weeks
Time frame: 8-weeks
Change in wrinkle scores (Photodocumentation via USR-Clip) for anti-wrinkle efficacy (3 trained graders will rank each pair of images at the area of the crow feet's in a blinded manner)
Time frame: 8-weeks
Subjective Evaluation of product traits assessed via questionnaire after 2, 4 and 8 weeks
Time frame: 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, MD study chair
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 Day Cream cosmetic product compared to untreated side, Night cream cosmetic product compared to untreated side and Eye cream cosmetic product compared to untreated side in people with Anti-Aging and 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 9 inclusion and 18 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?
Anti-wrinkle efficacy will be assessed in the periorbital regions wrinkles using DermaTOP. Parameters measured: Rz and Ra, representing mainly the rough structure (Rz) or the finer skin structure (Ra). (time frame: 8-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 6 Apr 2023.