Evaluating Facial Skin Quality Changes Post-Lipofilling

L'Oreal15 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Facial Aging

Eligibility

Sex: FEMALEMin age: 30 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Female patient volunteers 2. Over the age of 30 3. Who had decided to have adipose tissue injections and declared eligible to this intervention 4. Nonsmoker or less than 5 cigarettes per day 5. Informed about the study objectives and procedures, and able to understand them 6. Willing and able to fulfil the study requirements and schedule 7. Able to give their written informed consent 8. French subjects recruited must be affiliated to the French social security system. Exclusion Criteria: 1. Having participated within the 30 days before inclusion or currently participating in another clinical study. 2. Females in pregnancy or nursing 3. 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, 4. History of skin cancer or auto-immune disease, 5. History of allergy, hypersensitivity, or any serious reaction to any medicinal or cosmetic product, 6. Any concomitant medical condition that may interfere with the study conduct in the opinion of the investigator (diabetes, HIV+, hepatitis B and C…) 7. Surgical procedure to the face (face lift) 8. Cosmetic procedures: filler injection, botulinum toxin injection, laser to the face within the past 4 months 9. 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

Outcomes

Primary Outcomes

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).

Time frame: 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).

Time frame: 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).

Time frame: 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.

Time frame: Baseline up to 6 months post-procedure

Evaluating Facial Skin Quality Changes Post-Lipofilling

Overview

Conditions

Eligibility

Locations (1)

Outcomes

Primary Outcomes