Facial Fat Grafting for Skin Appearance
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.12345Why 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.678910
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Autologous fat graft injections performed on Day 0 after eligibility determination and baseline data collection
Follow-up
Participants are monitored for changes in facial skin characteristics and safety over a 12-month period
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?
2
Treatment groups
Experimental Treatment
Unwashed fat injected into both the left and right sides of the face.
Washed fat injected into both the left and right sides of the face.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Pittsburgh
Lead Sponsor
Published Research Related to This Trial
Citations
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 ...
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.
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 ...
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 ...
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 ...
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 ...
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 ...
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.
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.
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 ...
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