DMAE Oleate for Facial Skin Firmness and Fine Lines in Healthy Adults (NCT07255560) | Clinical Trial Compass
CompletedNot Applicable
DMAE Oleate for Facial Skin Firmness and Fine Lines in Healthy Adults
Spain30 participantsStarted 2025-09-09
Plain-language 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). 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.
Who can participate
Age range
40 Years – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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®.
Timeframe: Baseline (before product application) and after 4, 8, and 12 weeks of application.
2
Quantification of the skin firmness, elasticity, and fatigue from baseline to post-treatment visits using Cutometer®.
Timeframe: Baseline (before product application) and after 4, 8, and 12 weeks of application.
3
Completion of a self-assessment questionnaire.
Timeframe: Baseline (before product application) and after 4, 8, and 12 weeks of application.