Treatment for Facial Skin Texture

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
UPMC Aesthetic Plastic Surgery Center, Pittsburgh, PA
Facial Skin Texture+2 More
Eligibility
18+
All Sexes
What conditions do you have?
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Study 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.

Eligible Conditions

  • Facial Skin Texture
  • Facial Skin Pigmentation

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

7 Primary · 3 Secondary · Reporting Duration: 12 month

12 month
Change in facial skin characteristics as measured by the Participant Satisfaction questionnaire from baseline to 12 months, compared between the two cohorts.
Baseline, 12 months
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 Skin Quality Assessment (SQA) form from baseline up to 12 month assessment, compared between the two cohorts.
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.
Change in facial skin characteristics as measured by the cutometer from baseline up to 12 months, compared between groups.
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.
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.
To assess the safety of the autologous fat injections, compared between the two cohorts, from baseline to 12 months.

Trial Safety

Safety Progress

1 of 3

Trial Design

0 Treatment Group

26 Total Participants · 0 Treatment Group

Primary Treatment: Treatment · No Placebo Group · N/A

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 12 month
Closest Location: UPMC Aesthetic Plastic Surgery Center · Pittsburgh, PA
Photo of Pittsburgh 1Photo of Pittsburgh 2Photo of Pittsburgh 3
N/AFirst Recorded Clinical Trial
1 TrialsResearching Facial Skin Texture
0 CompletedClinical Trials

Who is running the clinical trial?

University of PittsburghLead Sponsor
1,595 Previous Clinical Trials
6,284,556 Total Patients Enrolled
J. Peter Rubin, MDPrincipal InvestigatorUniversity of Pittsburgh
10 Previous Clinical Trials
172 Total Patients Enrolled
Patsy Simon, BS, RN, CCRC, CCRA, ACRP-PMStudy DirectorUniversity of Pittsburgh

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a Fitzpatrick Skin Type Scale score of < 3.
You have a greater than moderate amount of facial hair.
Any of the following: Facial skin wrinkling, loss of elasticity, pigmentary changes, with greater than mild (≥4 on a 0 to 9 scale) signs of the following, per investigator discretion.
You have facial wrinkles (periorbital//periorbital//cheek).
You have rough skin texture.
You are willing to undergo the proposed treatment and comply with study procedures.
You have hyperpigmentation or skin tone that is lighter than your surrounding skin.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

References