Clinical Trial

DMAE Oleate for Facial Skin Firmness and Fine Lines in Healthy Adults

Completed
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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.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2025-11-20; most recent amendment 2026-01-29.
Status change: Active, Not Recruiting → Completed 2026-01-29
Trial Details
NCT Number NCT07255560
Lead Sponsor Bionos Biotech S.L.
Conditions Skin Aging of Face and Hands, Facial Wrinkles - Rough Texture - Hyperpigmentation, Skin Laxity
Enrollment 30 participants
Start Date 2025-09-09
Primary Completion 2025-12-02 (estimated)
Study Completion 2025-12-23 (estimated)
Updated on ClinicalTrials.gov 2026-01-30