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

Bionos Biotech

Status

Active, not recruiting

Conditions

Healthy Vollunteers

Treatments

Other: Topical DMAE Oleate

Study type

Interventional

Funder types

Industry

Identifiers

NCT07255560

DMAE_Oleate_2025

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 patients

Sex

All

Ages

40 to 55 years old

Volunteers

Accepts Healthy Volunteers

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.