AgingNCT05805735
Anti-Wrinkle Efficacy Study of an Eye-Cream
A study testing Face care product (Eye cream) in people with Aging and Wrinkle, run by Amazentis SA at 1 site in Germany.
Trial summary
The purpose of this study is to assess the anti-aging and reduction of dark circles efficacy of a cosmetic product after 8 weeks of application. Read more about this study
- Who is it for?
- Ages 40 to 65 yearsHealthy volunteers can take part
- What is being tested?
- Face care product (Eye cream)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteGermany
- Study dates
- 28 Mar 2023to 31 Aug 2023
- 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 (approx. 10% male)
- Between 40 and 65 years of age
- Visible wrinkles in the periorbital regions in accordance with the study site's score of at least grade 3
- Dark circles according to self-assessment (not guaranteed on darker skin types)
- Healthy skin in the test areas
- Uniform skin color and no erythema or dark pigmentation (except dark cycles are still visible) in the test area
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 18Show fewer
- 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
- Insulin-dependent diabetes mellitus
- Any topical medication at the test area within the last 7 days prior to the start of the study and/or throughout the entire course of the study
- Documented allergies to face care or cleansing products
- 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
- 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
- Epilepsy
- Obesity with a BMI > 40
- 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
- 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: Anti-Wrinkle Efficacy Study
The purpose of this study is to assess the anti-aging and reduction of dark circles efficacy of a cosmetic product after 8 weeks of application.
- Being tested
- Face care product (Eye cream)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Face care product (Eye cream)Other
The test material(s) will be cosmetic products to be applied around the eye region on both sides of the face daily. The test product will be applied twice daily in the morning and in the evening by the subjects
| Study group | Role | What they receive |
|---|---|---|
| Face care product (Eye cream) | Experimental | Comparison between assessment times. Assessments will be performed before, after 2, 4 and 8 weeks of product application. Receives: Other: Face care product (Eye cream) |
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 (9)
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
Dark circles color in difference by ColorFace image analysis Clinical assessment of dark circle reduction around the eye area by trained grader
Measured: 8-weeks
Clinical assessment of dark circle reduction by trained grader
Measured: 8-weeks
Subjective Evaluation of product traits assessed via questionnaire after 2, 4 and 8 weeks
Measured: 8-weeks
Assessment of eye area puffiness by photo ranking by 3 trained graders
Measured: 8-weeks
Photo documentation of skin by ColorFace
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 posted10 Apr 2023
- Study start28 Mar 2023
- Primary completion30 May 2023
- Study completion31 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Not applicable
- Intervention model
- Single group
- Model description
- Intra-individual comparison
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amazentis SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- proDERM GmbH
- Responsible party
- Sponsor
- Investigators
- Christiane Röck, Dipl. Biol, Principal investigator, SGS Proderm GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05805735
- Sponsor's protocol ID
- 23.0076-27
- Status last verified
- Sep 2023
- First submitted
- 28 Mar 2023
- Last updated
- 6 Sep 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 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anti-Wrinkle Efficacy Study
- ClinicalTrials.gov ID
- NCT05805735
- Acronym / sponsor ID
- 23.0076-27
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Amazentis SAIndustry (pharma, biotech, devices)
- Collaborators
- proDERM GmbH
- Study start
- 28 Mar 2023 (actual)
- Primary completion
- 30 May 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 10 Apr 2023 (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-aging and reduction of dark circles efficacy of a cosmetic product after 8 weeks of application.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Intra-individual comparison
| Arm | Type | Receives |
|---|---|---|
| Face care product (Eye cream) | Experimental | Other: Face care product (Eye cream)Comparison between assessment times. Assessments will be performed before, after 2, 4 and 8 weeks of product application. |
Who may qualify
- Ages
- 40 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 male (approx. 10% male)
- Between 40 and 65 years of age
- Visible wrinkles in the periorbital regions in accordance with the study site's score of at least grade 3
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 |
|---|---|---|
| Face care product (Eye cream)The test material(s) will be cosmetic products to be applied around the eye region on both sides of the face daily. The test product will be applied twice daily in the morning and in the evening by the subjects | Other | Face care product (Eye cream) |
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
9 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
Dark circles color in difference by ColorFace image analysis Clinical assessment of dark circle reduction around the eye area by trained grader
Time frame: 8-weeks
Clinical assessment of dark circle reduction by trained grader
Time frame: 8-weeks
Subjective Evaluation of product traits assessed via questionnaire after 2, 4 and 8 weeks
Time frame: 8-weeks
Assessment of eye area puffiness by photo ranking by 3 trained graders
Time frame: 8-weeks
Photo documentation of skin by ColorFace
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 Sep 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.
Christiane Röck, Dipl. Biol 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 Face care product (Eye cream) in people with Aging and Wrinkle, 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 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 Sep 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 Sep 2023.