CompletedNot Applicable

Autologous Facial Fat Grafting Study

United States26 participantsStarted 2022-10-17

Plain-language 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.

Who can participate

Age range35 Years – 70 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Ability to perform informed consent
✓. Healthy female adults, from 35 to 70 years of age
✓. Fitzpatrick Skin Type Scale scores \< 3.
✓. FWAS-greater than moderate, equal to or greater than 4
✓. Noticeable Physical signs of facial aging and sun damage including skin wrinkles, loss of elasticity and pigmentary changes, with greater than mild (≥4 on a 0 to 9 scale) signs of the following, per investigator discretion
✓. Facial wrinkles (periorbital//periorbital//cheek)
✓. Dyschromia (hyperpigmentation//uneven skin tone)
✓. Rough skin texture (visual skin roughness//pore sizes)

Exclusion criteria

✕. Age \< 35 or \> 70 years of age
✕. Any medical condition that would preclude safe administration of anesthesia and safe conduct of the adipose harvest procedure (such as an uncontrolled bleeding disorder or severe pulmonary disease), per investigator discretion.

What they're measuring

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.

Timeframe: Baseline, 12 months

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.

Timeframe: Baseline, 12 months

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.

Timeframe: Baseline, 12 months

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.

Timeframe: Baseline, 12 months

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.

Timeframe: Baseline, 12 months

Change in facial skin characteristics as measured by the Participant Satisfaction questionnaire from baseline to 12 months, compared between the two cohorts.

Timeframe: 12 month

Trial details

NCT IDNCT05482425

SponsorUniversity of Pittsburgh

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-09-30

View on ClinicalTrials.gov More Facial Skin Texture trials

Plain-language summary

Who can participate

Age range35 Years – 70 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Ability to perform informed consent
✓. Healthy female adults, from 35 to 70 years of age
✓. Fitzpatrick Skin Type Scale scores \< 3.
✓. FWAS-greater than moderate, equal to or greater than 4
✓. Noticeable Physical signs of facial aging and sun damage including skin wrinkles, loss of elasticity and pigmentary changes, with greater than mild (≥4 on a 0 to 9 scale) signs of the following, per investigator discretion
✓. Facial wrinkles (periorbital//periorbital//cheek)
✓. Dyschromia (hyperpigmentation//uneven skin tone)
✓. Rough skin texture (visual skin roughness//pore sizes)

Exclusion criteria

✕. Age \< 35 or \> 70 years of age
✕. Any medical condition that would preclude safe administration of anesthesia and safe conduct of the adipose harvest procedure (such as an uncontrolled bleeding disorder or severe pulmonary disease), per investigator discretion.

What they're measuring

Timeframe: Baseline, 12 months

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.

Timeframe: Baseline, 12 months

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.

Timeframe: Baseline, 12 months

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.

Timeframe: Baseline, 12 months

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.

Timeframe: Baseline, 12 months

Change in facial skin characteristics as measured by the Participant Satisfaction questionnaire from baseline to 12 months, compared between the two cohorts.

Timeframe: 12 month