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Facial Fat Grafting for Skin Appearance
N/A
Recruiting
Led By J. Peter Rubin, MD
Research Sponsored by University of Pittsburgh
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 month
Awards & highlights
Study Summary
This trial is testing whether washing fat before injecting it into the face impacts the appearance of the skin. One group will receive washed fat and one group will receive unwashed fat to compare the two.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Possible side effects may include swelling, bruising at injection/harvest sites, infection risk increase due to surgery-related factors. There might also be temporary numbness or discomfort around treated areas.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 month
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 month
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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.
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.
Change in facial skin characteristics as measured by the Participant Satisfaction questionnaire from baseline to 12 months, compared between the two cohorts.
+4 moreSecondary outcome measures
Change in facial skin characteristics by expert graders using a Griffth scale.
Compare investigator's rating of the change in facial skin characteristics, as recorded during baseline and 12 month history and physical exam form, compared between the two cohorts.
To assess the safety of the autologous fat injections, compared between the two cohorts, from baseline to 12 months.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Autologous facial fat graft injection-unwashed fatExperimental Treatment1 Intervention
Unwashed fat injected into both the left and right sides of the face.
Group II: Autologous facial fat graft injection- washed fatExperimental Treatment1 Intervention
Washed fat injected into both the left and right sides of the face.
Find a Location
Who is running the clinical trial?
University of PittsburghLead Sponsor
1,722 Previous Clinical Trials
16,342,910 Total Patients Enrolled
Patsy Simon, BS, RN, CCRC, CCRA, ACRP-PMStudy DirectorUniversity of Pittsburgh
Patsy Simon, BSRN,CCRC,CRA,PMStudy DirectorUniversity of Pittsburgh
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Eligibility Criteria:
This trial includes the following eligibility 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.I have not taken Accutane in the last year.I have a history of immune system problems or healing issues.I am willing to follow the treatment and study procedures.I haven't had facial cosmetic procedures like laser, Botox, or fillers in the last 6 months.I am younger than 35 or older than 70.I do not have any active infections on my face.I am a healthy woman aged between 35 and 70.I have been diagnosed with diabetes.I am not taking any medications or supplements that affect bleeding.I cannot provide enough fat for processing before a facial injection.I have visible signs of aging on my face, such as wrinkles and sun damage, rated 4 or higher.I agree not to have any cosmetic procedures on my face for 6 months.I am not currently taking any medications that weaken my immune system.I am not pregnant, breastfeeding, and I use effective birth control.I do not have skin rashes, infections, or lack of donor fat for autologous lipografting.
Research Study Groups:
This trial has the following groups:- Group 1: Autologous facial fat graft injection-unwashed fat
- Group 2: Autologous facial fat graft injection- washed fat
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this research study accept volunteers above the age of eighty?
"Candidates aged between 35 and 70 years old are being sought to participate in this investigation."
Answered by AI
Are there currently openings in this research protocol for participants?
"According to clinicaltrials.gov, this medical study has reached its recruitment goal and is no longer actively seeking participants; the post was first published on October 1st 2022 with a final update issued on October 6th of that same year. The good news is there are 30 other studies which need volunteers at this time."
Answered by AI
Which individuals are eligible to take part in this experimentation?
"This clinical research is offering participation to 26 women between the ages of 35 and 70 who display signs of facial pigmentation. Prerequisites for consideration include being able to provide informed consent, exhibiting a Fitzpatrick Skin Type Scale score under 3, having greater-than-moderate levels on the Facial Wrinkle Assessment Score (FWAS), displaying visible wrinkles around their eyes or cheeks as well as clumsy skin tone and texture with at least 4 points on a 0-9 scale in terms of severity, along with any other physical indicators associated with aging and sun damage. Additionally, female applicants must have taken an urine dip test which yields negative results if pregnancy is"
Answered by AI
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