Evaluating Facial Skin Quality Changes Post-Lipofilling

NCT07737639 | Completed

• 1 other identifier: ACR_MORE_17-06664
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Facial Aging

Keywords

autologous fat grafting; lipofilling; facial rejuvenation; adipose-derived stem cells; skin quality

Outcome Measures

Primary Outcomes (4)

• Change in Wrinkles and Fine Lines Severity

  Assessed by a trained expert using dynamic scales and photonumeric atlas books. This category evaluates the severity of crow's feet (grade 0-6), underneath eye wrinkles (grade 0-5), forehead wrinkles (grade 0-5), upper lip wrinkles (grade 0-6), nasolabial folds (grade 0-5), and cheek folds (grade 0-8). For all scales, a lower grade indicates less severe wrinkles (clinical improvement).

  Baseline up to 6 months post-procedure

• Change in Skin Pigmentation and Color Uniformity

  This category includes assessments of lateral and malar pigmentation (6-point scale), dark circles (grade 0-8), full face dyschromia/skin tone heterogeneity (6-point scale), and cheek erythrosis/redness (6-point scale). Lower grades indicate reduced pigmentation and more uniform skin tone (clinical improvement).

  Baseline up to 6 months post-procedure

• Change in Skin Elasticity, Sagging, and Structural Aging Signs

  Assessed clinically and via standardized photographs to evaluate structural skin changes. This includes grading of sagging/lower facial ptosis (grade 0-5), eye bags (grade 0-7), clinical skin elasticity on the cheek (6-point scale), and full face elastosis (6-point scale). Lower grades indicate less sagging and elastosis (clinical improvement).

  Baseline up to 6 months post-procedure

• Change in Skin Texture and Surface Quality

  This comprehensive category encompasses full face brightness (6-point scale, where higher is better), pore visibility (grade 0-7), water mobility (grade 0-10), papyraceus/papery aspect of the cheek (6-point scale), and skin surface parameters including oiliness, shininess, dryness, and roughness (4-point scales). With the exception of brightness, lower grades generally indicate smoother, improved skin texture.

  Baseline up to 6 months post-procedure

Study Arms (1)

Autologous Facial Fat Grafting

This cohort consists of healthy female volunteers, aged 30 and older, who have independently elected and scheduled to undergo a full-face autologous fat transfer (lipofilling) procedure for facial rejuvenation.

Eligibility Criteria

• Age: 30 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of individuals seeking aesthetic facial rejuvenation at the Hospices Civils de Lyon (HCL) in Lyon, France. Participants are recruited directly from the standard clinical practice of the principal investigator. A defining characteristic of this cohort is that all individuals have independently elected, and are already scheduled, to undergo an autologous facial fat transfer (lipofilling) procedure for anti-aging purposes prior to and independent of study enrollment. The study observes the outcomes of this pre-planned surgical intervention, with subsequent clinical and instrumental follow-up evaluations.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• L'Oreal: lead
• Hospices Civils de Lyon: collaborator

Study Sites (1)

L'Oréal

Aulnay-sous-Bois, 93600, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

The primary biospecimen retained in this study is human adipose tissue (lipoaspirate) collected as surgical waste during the participant's scheduled autologous fat grafting procedure. The tissue is harvested via liposuction primarily from the inner thigh or abdomen. Immediately following collection, the residual lipoaspirate is preserved at 4°C and transported to the research laboratory for comprehensive in vitro biological characterization.

Study Officials

• Stephanie Nouveau

  L'Oreal

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2026
• First Posted: July 30, 2026
• Study Start: January 10, 2021
• Primary Completion: November 10, 2023
• Study Completion: September 10, 2024
• Last Updated: July 30, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share

Locations

FR (1)