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

NCT07255560 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-01-30

No results posted yet for this study

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.

Conditions

  • Skin Aging of Face and Hands
  • Facial Wrinkles - Rough Texture - Hyperpigmentation
  • Skin Laxity

Interventions

OTHER

Topical DMAE Oleate

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.

Sponsors & Collaborators

  • Bionos Biotech S.L.

    lead INDUSTRY

Principal Investigators

  • Adela Serrano Gimeno, PhD · Bionos Biotech S.L. , LabAnalysis Life Science

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-09-09
Primary Completion
2025-12-02
Completion
2025-12-23

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07255560 on ClinicalTrials.gov