Facial Fat Grafting for Skin Appearance

N/A

Waitlist Available

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

No Placebo-Only Group

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.

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.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 month for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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.

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Secondary study objectives

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.