Autologous Facial Fat Grafting Study (NCT05482425) | Clinical Trial Compass
CompletedNot Applicable
Autologous Facial Fat Grafting Study
United States26 participantsStarted 2022-10-17
Plain-language summary
The goal of this study is to specifically examine changes in facial skin appearance after facial fat grafting with autologous fat tissue that has either been washed with sterile saline before injecting, or left unwashed. This will be testing two variations of a standard of care surgical procedure, in two cohorts of subjects. One group will receive washed fat, and one group will receive unwashed fat, to both sides of the face. There are no experimental devices, drugs, or biological agents being used in this study. All fat tissue is autologous from the subjects treated.
Significance: This study will provide evidence that may directly impact clinical practice for a common procedure in plastic surgery. Regardless of whether the null hypotheses is accepted or rejected, the data will be of direct clinical use and impact practice in the operating room.
Who can participate
Age range
35 Years – 70 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Ability to perform informed consent
. Healthy female adults, from 35 to 70 years of age
. Fitzpatrick Skin Type Scale scores \< 3.
. FWAS-greater than moderate, equal to or greater than 4
. Noticeable Physical signs of facial aging and sun damage including skin wrinkles, loss of elasticity and pigmentary changes, with greater than mild (≥4 on a 0 to 9 scale) signs of the following, per investigator discretion
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in facial skin characteristics as measured by the Fitzpatrick Wrinkle Scale (FWAS) from baseline to 12 month assessment, compared between the two cohorts. Scale (FWAS) from baseline to 12 month assessment, compared between the two cohorts.
Timeframe: Baseline, 12 months
2
Change in facial skin characteristics as measured by the Skin Quality Assessment (SQA) form from baseline up to 12 month assessment, compared between the two cohorts.
Timeframe: Baseline, 12 months
3
Change in facial skin characteristics as measured by the Subject Satisfaction Scale (SSA) form from baseline up to 12 month assessment, compared between the two cohorts.
Timeframe: Baseline, 12 months
4
Self esteem as measured by the Heatherton and Polivy State Self Esteem Scale (SESS) form from baseline to 12 month assessment, compared between the two cohorts.
Timeframe: Baseline, 12 months
5
Change in facial skin characteristics as measured by the Global Aesthetic Improvement Scale (GAIS) form from baseline to 12 month assessment, compared between the two cohorts.
Timeframe: Baseline, 12 months
6
Change in facial skin characteristics as measured by the Participant Satisfaction questionnaire from baseline to 12 months, compared between the two cohorts.
. Any medical condition that would preclude safe administration of anesthesia and safe conduct of the adipose harvest procedure (such as an uncontrolled bleeding disorder or severe pulmonary disease), per investigator discretion.
. Active infection on the face (e.g., acne, HSV (herpes simplex), etc.,) per investigator discretion.
. Female in pregnancy (positive pregnancy-test performed before inclusion) or lactation or without effective contraception)
. Received laser, IPL, botox (6 months), injectable fillers or other surgical cosmetic procedures on the face within 12 months of study consent and screening date. -prohibited for 6 months
. Acutane use within past 12 months
. Individuals with any contraindications of autologous lipografting, such as cutaneous rashes or infection in the area of intended fat harvest, lack of available donor fat, or other factors that, in the determination of the investigator, would be considered a contraindication.
. Individuals diagnosed with known allergies to skin care products, topical antibiotics, adhesives, bandages, lidocaine, epinephrine, or other agents that might be used in the study
Timeframe: 12 month
7
Change in facial skin characteristics as measured by the cutometer from baseline up to 12 months, compared between groups.