Skin Aging of Face and HandsNCT07255560
DMAE Oleate for Facial Skin Firmness and Fine Lines in Healthy Adults
A study testing Topical DMAE Oleate in people with Skin Aging of Face and Hands and Facial Wrinkles - Rough Texture - Hyperpigmentation, run by Bionos Biotech S.L. at 1 site in Spain.
Trial summary
This single-arm, cosmetic study will evaluate the efficacy of topical DMAE Oleate on facial skin firmness and lines/wrinkles in healthy adults. Thirty volunteers (40-55 years) will apply DMAE Oleate at night for 12 weeks (week 1: Monday/Wednesday/Friday/Sunday; weeks 2 to 12: nightly, one pump dose). Read more about this study
- Who is it for?
- Ages 40 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Skin Aging of Face and Hands, Facial Wrinkles - Rough Texture - Hyperpigmentation, Skin Laxity
- What is being tested?
- Topical DMAE Oleate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 9 Sep 2025to 23 Dec 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 40 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Volunteers with visible signs of fine lines and wrinkles.
- Volunteers with visible signs of skin laxity/sagging.
- Informed of the purpose and the protocol of the study and signed a written informed-consent form.
- Additional criteria to be included by the client.
Who cannot join
- Volunteers with sensitive skin.
- Pre-existing skin conditions: Eczema, Rosacea.
- Pregnancy/breastfeeding/planning pregnancy.
- Known allergy/sensitivity to any component of the product.
- Agree to avoid excessive sun exposure/self-tanning product/avoid tanning salons/solariums.
- No lasers/tretinoin/procedures/facial hair removal/facials 2 weeks prior or during the study.
- Additional criteria to be included by the client.
- Any condition judged by the investigator to be unsuitable for participation in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Evaluation of the Cosmetic Efficacy of the Product DMAE Oleate Aimed at Increasing Skin Firmness and Reducing Fine Lines and Wrinkles in Human Volunteers.
This single-arm, cosmetic study will evaluate the efficacy of topical DMAE Oleate on facial skin firmness and lines/wrinkles in healthy adults. Thirty volunteers (40-55 years) will apply DMAE Oleate at night for 12 weeks (week 1: Monday/Wednesday/Friday/Sunday; weeks 2 to 12: nightly, one pump dose). Efficacy will be assessed at baseline, week 4, week 8, and week 12. The primary goals are to determine changes in fine lines/wrinkles at the crow's-feet region and biomechanical properties of the face skin. Wrinkle area, depth, and volume will be quantified by standardized VISIA-CR® image analysis, while firmness, elasticity, and fatigue will be measured with a Cutometer®. Participants will also complete a self-assessment questionnaire at each time point. Measurements are performed under identical conditions at all visits to enable within-subject comparisons from baseline.
Read the detailed description
Skin aging reflects intrinsic and extrinsic processes that reduce collagen/elastin, diminish hyaluronic acid, and compromise firmness and elasticity, leading to fine lines and wrinkles. In this cosmetic study, investigators will assess the efficacy of topical DMAE Oleate on facial skin by quantifying changes in fine lines/wrinkles and biomechanical parameters of firmness, elasticity, and fatigue in healthy adult volunteers.
Thirty healthy volunteers aged 40-55 years with visible fine lines/wrinkles and signs of laxity/sagging will be enrolled at Bionos Biotech S.L. (Valencia, Spain) following informed consent and eligibility confirmation. Participants will receive DMAE Oleate in individual containers and will apply one pump topically once daily at night according to a fixed regimen: Week 1 on Monday, Wednesday, Friday, and Sunday; Weeks 2-12 nightly. Product handling and use will follow written instructions (apply to clean, dry facial skin; avoid the eye area; allow normal absorption before any other routine), and containers will be collected/verified at visits to support compliance documentation. All procedures and data processing will take place at Bionos Biotech facilities under standardized site conditions.
Assessments will be performed at baseline (D0), week 4 (D28), week 8 (D56), and week 12 (D84), in the same order at each visit to enable within-subject comparisons: (1) VISIA-CR® imaging of the crow's-feet region to quantify wrinkle area, depth, and volume; (2) Cutometer® measurements on facial skin to determine firmness, elasticity, and fatigue; and (3) completion of a self-assessment questionnaire. Participants will be reminded to maintain normal diet and hygiene, to refrain from initiating new/interfering cosmetics or oral supplements, to avoid excessive sun exposure and self-tanning/tanning salons, and to forgo intense or invasive cosmetic procedures for the study duration. The investigational product has undergone the required safety patch test prior to volunteer use; adverse events will be collected at each visit and managed according to site procedures. Volunteers must maintain normal diet and hygiene, refrain from starting new/interfering cosmetics or oral supplements, avoid excessive sun exposure and self-tanning/tanning salons, and forgo intense/invasive cosmetic treatments; contraception methods should remain unchanged from 6 weeks prior through study end. Key exclusions include sensitive skin; eczema/rosacea; pregnancy, breastfeeding, or planned pregnancy; and known allergy/sensitivity to product components.
The primary analysis will compare within-subject changes from baseline to post-treatment time points using paired t-tests or Wilcoxon signed-rank tests (two-sided α=0.05). A sample of 30 participants is expected, based on prior center experience, to detect ≈5-10% differences with 80% power, acknowledging that this is the first evaluation of this product.
Ethical conduct follows the Declaration of Helsinki, ICH guidelines, and local committee approvals; informed consent was obtained before any procedure. Data are coded and handled under Spanish data-protection law.
- Conditions
- Skin Aging of Face and Hands, Facial Wrinkles - Rough Texture - Hyperpigmentation, Skin Laxity
- Being tested
- Topical DMAE Oleate
- Keywords
- DMAE Oleate, Skin firmness, Fine lines & wrinkles, VISIA-CR imaging, Cutometer elasticity/fatigue
- Medical subject headings
- Cutis Laxa, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical DMAE OleateOther
Volunteers will be provided with the product DMAE Oleate and instructed to apply one pump topically at night for 12 weeks (week 1: Monday, Wednesday, Friday, Sunday; weeks 2 to 12: nightly). Efficacy will be evaluated at baseline (D0) and at 4, 8, and 12 weeks using VISIA-CR® (crow's-feet wrinkle area/depth/volume), Cutometer® (firmness, elasticity, fatigue), and a self-assessment questionnaire. Product is supplied in individual containers and stored in a cool, dry place; a patch test has been performed for safety. All procedures occur at Bionos Biotech S.L. facilities.
| Study group | Role | What they receive |
|---|---|---|
| DMAE Oleate | Experimental | This group will be provided with the product DMAE Oleate. Receives: Other: Topical DMAE Oleate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantification of the change in facial fine lines and wrinkles (crow's-feet) - area, depth, and volume - from baseline to post-treatment visits using VISIA-CR®.
Thirty healthy volunteers (40-55 years) will apply topical DMAE Oleate for 12 weeks (week 1: Monday/Wednesday/Friday/Sunday at night; weeks 2 to 12: nightly, one pump). Standardized image capture with VISIA-CR® will be performed on the crow's-feet region at baseline (D0) and at 4 (D28), 8 (D56), and 12 weeks (D84) after application to compute wrinkle area, depth, and volume. All procedures are conducted at Bionos Biotech S.L. facilities under a fixed schedule; product is supplied in individual containers, one-pump dose, stored cool and dry. A safety patch test has been completed prior to volunteer use.
Measured: Baseline (before product application) and after 4, 8, and 12 weeks of application.
Quantification of the skin firmness, elasticity, and fatigue from baseline to post-treatment visits using Cutometer®.
Thirty healthy volunteers (40-55 years) will apply topical DMAE Oleate for 12 weeks (week 1: Monday/Wednesday/Friday/Sunday at night; weeks 2 to 12: nightly, one pump). Cutometer® measurements will be performed on facial skin to determine firmness, elasticity, and fatigue at baseline (D0) and at 4 (D28), 8 (D56), and 12 weeks (D84) after application. All procedures are conducted at Bionos Biotech S.L. facilities under a fixed schedule; product is supplied in individual containers, one-pump dose, stored cool and dry. A safety patch test has been completed prior to volunteer use.
Measured: Baseline (before product application) and after 4, 8, and 12 weeks of application.
Completion of a self-assessment questionnaire.
Thirty healthy volunteers (40-55 years) will apply topical DMAE Oleate for 12 weeks (week 1: Monday/Wednesday/Friday/Sunday at night; weeks 2 to 12: nightly, one pump). Participants will complete a self-assessment questionnaire at baseline (D0) and at 4 (D28), 8 (D56), and 12 weeks (D84) after application to provide a subjective evaluation of the treatment. All procedures are conducted at Bionos Biotech S.L. facilities under a fixed schedule; product is supplied in individual containers, one-pump dose, stored cool and dry. A safety patch test has been completed prior to volunteer use.
Measured: Baseline (before product application) and after 4, 8, and 12 weeks of application.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2025
- Study start9 Sep 2025
- Primary completion2 Dec 2025
- Study completion23 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin Aging of Face and HandsStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bionos Biotech S.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Adela Serrano Gimeno, PhD, Principal investigator, Bionos Biotech S.L. , LabAnalysis Life Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07255560
- Sponsor's protocol ID
- DMAE_Oleate_2025
- Status last verified
- Jan 2026
- First submitted
- 20 Nov 2025
- Last updated
- 30 Jan 2026
- 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 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the Cosmetic Efficacy of the Product DMAE Oleate Aimed at Increasing Skin Firmness and Reducing Fine Lines and Wrinkles in Human Volunteers.
- ClinicalTrials.gov ID
- NCT07255560
- Acronym / sponsor ID
- DMAE_Oleate_2025
- Conditions
- Skin Aging of Face and Hands, Facial Wrinkles - Rough Texture - Hyperpigmentation, Skin Laxity
- Keywords
- DMAE Oleate, Skin firmness, Fine lines & wrinkles, VISIA-CR imaging, Cutometer elasticity/fatigue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Bionos Biotech S.L.Industry (pharma, biotech, devices)
- Study start
- 9 Sep 2025 (actual)
- Primary completion
- 2 Dec 2025 (actual)
- Study completion
- 23 Dec 2025 (actual)
- First posted
- 1 Dec 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.
This single-arm, cosmetic study will evaluate the efficacy of topical DMAE Oleate on facial skin firmness and lines/wrinkles in healthy adults. Thirty volunteers (40-55 years) will apply DMAE Oleate at night for 12 weeks (week 1: Monday/Wednesday/Friday/Sunday; weeks 2 to 12: nightly, one pump dose). Efficacy will be assessed at baseline, week 4, week 8, and week 12. The primary goals are to determine changes in fine lines/wrinkles at the crow's-feet region and biomechanical properties of the face skin. Wrinkle area, depth, and volume will be quantified by standardized VISIA-CR® image analysis, while firmness, elasticity, and fatigue will be measured with a Cutometer®. Participants will also complete a self-assessment questionnaire at each time point. Measurements are performed under identical conditions at all visits to enable within-subject comparisons from baseline.
Detailed description
Skin aging reflects intrinsic and extrinsic processes that reduce collagen/elastin, diminish hyaluronic acid, and compromise firmness and elasticity, leading to fine lines and wrinkles. In this cosmetic study, investigators will assess the efficacy of topical DMAE Oleate on facial skin by quantifying changes in fine lines/wrinkles and biomechanical parameters of firmness, elasticity, and fatigue in healthy adult volunteers.
Thirty healthy volunteers aged 40-55 years with visible fine lines/wrinkles and signs of laxity/sagging will be enrolled at Bionos Biotech S.L. (Valencia, Spain) following informed consent and eligibility confirmation. Participants will receive DMAE Oleate in individual containers and will apply one pump topically once daily at night according to a fixed regimen: Week 1 on Monday, Wednesday, Friday, and Sunday; Weeks 2-12 nightly. Product handling and use will follow written instructions (apply to clean, dry facial skin; avoid the eye area; allow normal absorption before any other routine), and containers will be collected/verified at visits to support compliance documentation. All procedures and data processing will take place at Bionos Biotech facilities under standardized site conditions.
Assessments will be performed at baseline (D0), week 4 (D28), week 8 (D56), and week 12 (D84), in the same order at each visit to enable within-subject comparisons: (1) VISIA-CR® imaging of the crow's-feet region to quantify wrinkle area, depth, and volume; (2) Cutometer® measurements on facial skin to determine firmness, elasticity, and fatigue; and (3) completion of a self-assessment questionnaire. Participants will be reminded to maintain normal diet and hygiene, to refrain from initiating new/interfering cosmetics or oral supplements, to avoid excessive sun exposure and self-tanning/tanning salons, and to forgo intense or invasive cosmetic procedures for the study duration. The investigational product has undergone the required safety patch test prior to volunteer use; adverse events will be collected at each visit and managed according to site procedures. Volunteers must maintain normal diet and hygiene, refrain from starting new/interfering cosmetics or oral supplements, avoid excessive sun exposure and self-tanning/tanning salons, and forgo intense/invasive cosmetic treatments; contraception methods should remain unchanged from 6 weeks prior through study end. Key exclusions include sensitive skin; eczema/rosacea; pregnancy, breastfeeding, or planned pregnancy; and known allergy/sensitivity to product components.
The primary analysis will compare within-subject changes from baseline to post-treatment time points using paired t-tests or Wilcoxon signed-rank tests (two-sided α=0.05). A sample of 30 participants is expected, based on prior center experience, to detect ≈5-10% differences with 80% power, acknowledging that this is the first evaluation of this product.
Ethical conduct follows the Declaration of Helsinki, ICH guidelines, and local committee approvals; informed consent was obtained before any procedure. Data are coded and handled under Spanish data-protection law.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DMAE Oleate | Experimental | Other: Topical DMAE OleateThis group will be provided with the product DMAE Oleate. |
Who may qualify
- Ages
- 40 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Volunteers with visible signs of fine lines and wrinkles.
- Volunteers with visible signs of skin laxity/sagging.
- Informed of the purpose and the protocol of the study and signed a written informed-consent form.
- Additional criteria to be included by the client.
Key exclusion criteria (8 listed)
- Volunteers with sensitive skin.
- Pre-existing skin conditions: Eczema, Rosacea.
- Pregnancy/breastfeeding/planning pregnancy.
- Known allergy/sensitivity to any component of the product.
- Agree to avoid excessive sun exposure/self-tanning product/avoid tanning salons/solariums.
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 DMAE OleateVolunteers will be provided with the product DMAE Oleate and instructed to apply one pump topically at night for 12 weeks (week 1: Monday, Wednesday, Friday, Sunday; weeks 2 to 12: nightly). Efficacy will be evaluated at baseline (D0) and at 4, 8, and 12 weeks using VISIA-CR® (crow's-feet wrinkle area/depth/volume), Cutometer® (firmness, elasticity, fatigue), and a self-assessment questionnaire. Product is supplied in individual containers and stored in a cool, dry place; a patch test has been performed for safety. All procedures occur at Bionos Biotech S.L. facilities. | Other | DMAE Oleate |
Primary outcome
Quantification of the change in facial fine lines and wrinkles (crow's-feet) - area, depth, and volume - from baseline to post-treatment visits using VISIA-CR®.
Time frame: Baseline (before product application) and after 4, 8, and 12 weeks of application.
Thirty healthy volunteers (40-55 years) will apply topical DMAE Oleate for 12 weeks (week 1: Monday/Wednesday/Friday/Sunday at night; weeks 2 to 12: nightly, one pump). Standardized image capture with VISIA-CR® will be performed on the crow's-feet region at baseline (D0) and at 4 (D28), 8 (D56), and 12 weeks (D84) after application to compute wrinkle area, depth, and volume. All procedures are conducted at Bionos Biotech S.L. facilities under a fixed schedule; product is supplied in individual containers, one-pump dose, stored cool and dry. A safety patch test has been completed prior to volunteer use.
Quantification of the skin firmness, elasticity, and fatigue from baseline to post-treatment visits using Cutometer®.
Time frame: Baseline (before product application) and after 4, 8, and 12 weeks of application.
Thirty healthy volunteers (40-55 years) will apply topical DMAE Oleate for 12 weeks (week 1: Monday/Wednesday/Friday/Sunday at night; weeks 2 to 12: nightly, one pump). Cutometer® measurements will be performed on facial skin to determine firmness, elasticity, and fatigue at baseline (D0) and at 4 (D28), 8 (D56), and 12 weeks (D84) after application. All procedures are conducted at Bionos Biotech S.L. facilities under a fixed schedule; product is supplied in individual containers, one-pump dose, stored cool and dry. A safety patch test has been completed prior to volunteer use.
Completion of a self-assessment questionnaire.
Time frame: Baseline (before product application) and after 4, 8, and 12 weeks of application.
Thirty healthy volunteers (40-55 years) will apply topical DMAE Oleate for 12 weeks (week 1: Monday/Wednesday/Friday/Sunday at night; weeks 2 to 12: nightly, one pump). Participants will complete a self-assessment questionnaire at baseline (D0) and at 4 (D28), 8 (D56), and 12 weeks (D84) after application to provide a subjective evaluation of the treatment. All procedures are conducted at Bionos Biotech S.L. facilities under a fixed schedule; product is supplied in individual containers, one-pump dose, stored cool and dry. A safety patch test has been completed prior to volunteer use.
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 30 Jan 2026.
- Individual participant dataSharing planned: No
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.
Adela Serrano Gimeno, PhD principal investigator
Bionos Biotech S.L. , LabAnalysis Life Science
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 DMAE Oleate in people with Skin Aging of Face and Hands and Facial Wrinkles - Rough Texture - Hyperpigmentation, run by Bionos Biotech S.L. at 1 site in Spain.
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 4 inclusion and 8 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 30 Jan 2026. 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 Spain. 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?
Quantification of the change in facial fine lines and wrinkles (crow's-feet) - area, depth, and volume - from baseline to post-treatment visits using VISIA-CR®. (time frame: Baseline (before product application) and after 4, 8, and 12 weeks of application.). The study lists 3 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 30 Jan 2026.