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

NCT07255560 | Completed

• 1 other identifier: DMAE_Oleate_2025
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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; Skin Laxity; Facial Wrinkles - Rough Texture - Hyperpigmentation

Keywords

DMAE Oleate; Skin firmness; Fine lines & wrinkles; VISIA-CR imaging; Cutometer elasticity/fatigue

Outcome Measures

Primary Outcomes (3)

• 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®.

  Thirty healthy volunteers (40-55 years) will apply topical DMAE Oleate for 12 weeks (week 1: Monday/Wednesday/Friday/Sunday at night; weeks 2 to 12: nightly, one pump). Standardized image capture with VISIA-CR® will be performed on the crow's-feet region at baseline (D0) and at 4 (D28), 8 (D56), and 12 weeks (D84) after application to compute wrinkle area, depth, and volume. All procedures are conducted at Bionos Biotech S.L. facilities under a fixed schedule; product is supplied in individual containers, one-pump dose, stored cool and dry. A safety patch test has been completed prior to volunteer use.

  Baseline (before product application) and after 4, 8, and 12 weeks of application.

• Quantification of the skin firmness, elasticity, and fatigue from baseline to post-treatment visits using Cutometer®.

  Thirty healthy volunteers (40-55 years) will apply topical DMAE Oleate for 12 weeks (week 1: Monday/Wednesday/Friday/Sunday at night; weeks 2 to 12: nightly, one pump). Cutometer® measurements will be performed on facial skin to determine firmness, elasticity, and fatigue at baseline (D0) and at 4 (D28), 8 (D56), and 12 weeks (D84) after application. All procedures are conducted at Bionos Biotech S.L. facilities under a fixed schedule; product is supplied in individual containers, one-pump dose, stored cool and dry. A safety patch test has been completed prior to volunteer use.

  Baseline (before product application) and after 4, 8, and 12 weeks of application.

• Completion of a self-assessment questionnaire.

  Thirty healthy volunteers (40-55 years) will apply topical DMAE Oleate for 12 weeks (week 1: Monday/Wednesday/Friday/Sunday at night; weeks 2 to 12: nightly, one pump). Participants will complete a self-assessment questionnaire at baseline (D0) and at 4 (D28), 8 (D56), and 12 weeks (D84) after application to provide a subjective evaluation of the treatment. All procedures are conducted at Bionos Biotech S.L. facilities under a fixed schedule; product is supplied in individual containers, one-pump dose, stored cool and dry. A safety patch test has been completed prior to volunteer use.

  Baseline (before product application) and after 4, 8, and 12 weeks of application.

Study Arms (1)

DMAE Oleate

EXPERIMENTAL

This group will be provided with the product DMAE Oleate.

Other: Topical DMAE Oleate

Interventions

Topical DMAE Oleate OTHER

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.

DMAE Oleate

Eligibility Criteria

• Age: 40 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bionos Biotech S.L.: lead

Study Sites (1)

Bionos Biotech S.L., LabAnalysis Life Science

Valencia, 46007, Spain

Location

MeSH Terms

Conditions

Cutis Laxa; Fatigue

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Adela Serrano Gimeno, PhD

  Bionos Biotech S.L. , LabAnalysis Life Science

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2025
• First Posted: December 1, 2025
• Study Start: September 9, 2025
• Primary Completion: December 2, 2025
• Study Completion: December 23, 2025
• Last Updated: January 30, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)