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.

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.