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NCT07737639

Overview

NCT ID: NCT07737639
Lead Sponsor: L'OrealINDUSTRY
Official Title: A MONOCENTER, OPEN STUDY TO ASSESS THE CHANGES INDUCED BY A LIPOFILLING PROCEDURE ON FACIAL SKIN QUALITY AND AGEING SIGNS IN WOMEN
Brief Summary: The goal of this prospective observational study is to evaluate changes in facial skin quality and identify predictive biological markers in donor adipose tissue in healthy women undergoing autologous facial fat transfer. The main questions it aims to answer are:

How does full-face lipofilling alter clinical signs of aging, such as wrinkles, sagging, and skin texture, over a 6-month period? Which baseline biological characteristics (e.g., cellular stemness, extracellular matrix remodeling, angiogenesis) within the donor fat graft predict these clinical skin quality outcomes?

Participants will:

Undergo a standard full-face autologous fat transfer (lipofilling) procedure. Attend follow-up evaluation visits at 1.5, 3, and 6 months post-procedure. Undergo non-invasive clinical and instrumental skin assessments (e.g., standardized photography, 3D topography, echography, and cutometry).

Complete self-assessment questionnaires regarding perceived skin changes and overall satisfaction with the procedure.

Status and Timeline

Status: Completed
Last Update Posted: Jul 30, 2026Actual
Start Date: Jan 10, 2021Actual
Primary Completion Date: Nov 10, 2023Actual
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: Female
Accepts Healthy Volunteers?: Yes
Eligibility Criteria: Inclusion Criteria:

Female patient volunteers

Over the age of 30

Who had decided to have adipose tissue injections and declared eligible to this intervention

Nonsmoker or less than 5 cigarettes per day

Informed about the study objectives and procedures, and able to understand them

Willing and able to fulfil the study requirements and schedule

Able to give their written informed consent

French subjects recruited must be affiliated to the French social security system.

Exclusion Criteria:

Having participated within the 30 days before inclusion or currently participating in another clinical study.

Females in pregnancy or nursing

Dermatological disorder affecting the investigational areas (like severe acne, rosacea eczema, atopy, psoriasis, seborrheic dermatitis) that may interfere with the study conduct or the study results in the opinion of the Investigator,

History of skin cancer or auto-immune disease,

History of allergy, hypersensitivity, or any serious reaction to any medicinal or cosmetic product,

Any concomitant medical condition that may interfere with the study conduct in the opinion of the investigator (diabetes, HIV+, hepatitis B and C…)

Surgical procedure to the face (face lift)

Cosmetic procedures: filler injection, botulinum toxin injection, laser to the face within the past 4 months

Actual or past use of systemic or topic drugs, that would interfere with assessment and/or investigational treatments and affect study results in the opinion of the investigator

Study Plan

Study Type: Observational
Phase: No data available
Enrollment: 15Actual
Primary Purpose: No data available
Allocation: No data available
Interventional Model: No data available
Masking: No data available

Contacts and Locations

Central Contacts: No data available
Locations: L'Oréal

Overview

Status and Timeline

Participation Criteria

Study Plan

Contacts and Locations

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