Facial Fat Grafting for Skin Appearance

Overseen By Anne Lindsey, BS

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Pittsburgh

Must not be taking: Aspirin, Warfarin, Corticosteroids, others

Disqualifiers: Pregnancy, Active infection, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how facial skin appears after a procedure called facial fat grafting, which uses a person's own fat to improve skin appearance and texture. Researchers aim to determine whether washing the fat with saline before injection affects the results. Participants will be divided into two groups: one will receive washed fat, and the other unwashed fat. This study targets healthy women aged 35-70 with visible signs of facial aging, such as wrinkles and uneven skin tone, who are willing to avoid other cosmetic treatments for six months. As an unphased study, this trial offers an opportunity to contribute to innovative research that could enhance cosmetic procedures.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it mentions that individuals taking substances affecting bleeding time or impairing the immune system may be excluded. It's best to discuss your specific medications with the trial team.

What prior data suggests that this procedure is safe for facial skin appearance?

Research shows that using one's own fat for facial treatments is generally safe, though some risks exist. A review found problems in about 1.94% of cases, with common issues like small lumps or infections occurring in about 0.54% of cases.

Studies have shown that whether the fat is cleaned before use does not affect safety or patient satisfaction. However, complications can still arise, ranging from minor issues like swelling to more serious problems like vision loss or fat cell death.

Overall, while the treatment is usually well-tolerated, participants should be aware of these rare but possible side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about autologous facial fat grafting for skin appearance because it uses the patient's own fat, offering a natural and biocompatible alternative to synthetic fillers. Unlike standard treatments like hyaluronic acid fillers that temporarily add volume, this method potentially provides longer-lasting results by integrating living fat cells into the facial tissue. Additionally, the study explores two variations—washed and unwashed fat injections—which may reveal important insights into optimizing fat grafting techniques for improved skin appearance.

What evidence suggests that this trial's treatments could be effective for improving facial skin appearance?

Research shows that using one's own fat as a filler, known as autologous fat grafting, can effectively enhance facial appearance. Studies have found that this method not only adds volume but also improves skin texture and smoothness. One study discovered it improved facial balance by about 13%. The fat used is safe for the body, reducing the risk of negative reactions. Another review emphasized its overall safety and effectiveness for cosmetic improvements. However, some studies mention that a significant amount of the fat may be reabsorbed over time, affecting the longevity of results. In this trial, participants will receive either unwashed or washed autologous facial fat graft injections to assess differences in outcomes. ^{6 7 8 9 10}

Who Is on the Research Team?

Patsy Simon, BS, RN, CCRC, CCRA, ACRP-PM

Principal Investigator

University of Pittsburgh

J. Peter Rubin, MD

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

Healthy women aged 35-70 with moderate to severe facial aging signs, such as wrinkles and uneven skin tone. They must be willing to follow study procedures, not pregnant or breastfeeding, have a Fitzpatrick Skin Type Scale score <3, and avoid certain cosmetic treatments for 6 months. Exclusions include recent cosmetic procedures on the face, contraindications to fat grafting like infections at harvest site, bleeding disorders, uncontrolled diseases affecting safety or healing.

Inclusion Criteria

My walking ability is moderately affected or worse.

I can provide enough fat tissue for donation (up to 1 liter).

I understand and can give consent for my treatment.

Exclusion Criteria

I have not taken Accutane in the last year.

I have a history of immune system problems or healing issues.

I haven't had facial cosmetic procedures like laser, Botox, or fillers in the last 6 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Autologous fat graft injections performed on Day 0 after eligibility determination and baseline data collection

1 day

1 visit (in-person)

Follow-up

Participants are monitored for changes in facial skin characteristics and safety over a 12-month period

12 months

Multiple visits (in-person and virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Autologous facial fat graft injection

Trial Overview The trial is testing the effects of autologous facial fat grafting on skin appearance by comparing two methods: one using washed fat tissue and another using unwashed fat. This non-experimental procedure involves injecting patients' own harvested fat into their faces to see if there's a difference in outcomes between the two techniques.

How Is the Trial Designed?

Group I: Autologous facial fat graft injection-unwashed fat Experimental Treatment 1 Intervention

Unwashed fat injected into both the left and right sides of the face.

Group II: Autologous facial fat graft injection- washed fat Experimental Treatment 1 Intervention

Washed fat injected into both the left and right sides of the face.

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials

1,820

Recruited

16,360,000+

Published Research Related to This Trial

Doppler-ultrasound (DUS) imaging was successfully used in a study of 20 female patients (average age 57.9 years) to safely guide the harvesting and injection of autologous fat for facial lipofilling, helping to visualize and avoid the temporal artery during the procedure.

The study reported only one case of edema and nodules, indicating a favorable safety profile for DUS-guided lipofilling, suggesting that DUS should be considered an essential part of the procedure to enhance safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultrasound to Improve the Safety and Efficacy of Lipofilling of the Temples. Kadouch, J., Schelke, LW., Swift, A.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5889440/

Autologous Fat Transfer for Facial Rejuvenation As a dermal, facial filler, autologous fat transfer (AFT) seems to have real potential because of the biocompatibility of adipose tissue besides being a ...

2. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK557860/

Autologous Fat Grafting for Facial Rejuvenation - NCBI - NIH Autologous fat grafting intended for facial rejuvenation restores volume to the face and can also revitalize skin by improving tone and texture.

3. sciencedirect.com sciencedirect.com/science/article/pii/S1748681523005016

Quantifying outcomes of autologous fat transplantation in ... Overall, autologous fat transplantation improved facial symmetry by 13% (95% CI: 8.4%–18%). Conclusion. Autologous fat transplantation is generally a safe and ...

4. frontiersin.org frontiersin.org/journals/surgery/articles/10.3389/fsurg.2024.1410162/full

Autologous fat grafting for cosmetic temporal augmentation Current studies show a loss of transplanted fat in the temporal area of 20%–90% only 1 year after treatment, resulting in poor aesthetic ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2352587818300494

A systematic review of the effectiveness and complications ... The objective of this study was to evaluate the safety and efficacy of fat grafting to the facial region for the reconstruction and aesthetic enhancement of ...

6. oaepublish.com oaepublish.com/articles/2347-9264.2023.94

Complications of facial autologous fat grafting This chapter details the complications of fat grafting, ranging from major (i.e., vision loss, cerebral infarct) to minor (i.e., prolonged edema ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7061561/

A systematic review of the effectiveness and complications of ... The objective of this study was to evaluate the safety and efficacy of fat grafting to the facial region for the reconstruction and aesthetic enhancement of ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8423194/

Autologous Fat Grafting with or without Processing: A Study ... There was not a statistically significant difference in patient outcomes following fat grafting, with or without processing, in terms of patient satisfaction.

9. jprasurg.com jprasurg.com/article/S1748-6815(23)00014-1/abstract

Achieving optimal clinical outcomes in autologous fat grafting Safety profiles of fat processing techniques in autologous fat transfer ... A clinical trial in facial fat grafting: filtered and washed versus centrifuged fat.

10. sciencedirect.com sciencedirect.com/science/article/pii/S2049080117302406

Procedure, applications, and outcomes of autologous fat ... From top to bottom: First layer of lipids, second layer of fatty tissue, and third layer of blood and local anaesthetics. 4. Fat injection. Despite a long ...