Pilot Study Investigating the Efficacy of Fat Grafting as a Treatment for Male and Female Facial … (NCT04559022) | Clinical Trial Compass
CompletedNot Applicable
Pilot Study Investigating the Efficacy of Fat Grafting as a Treatment for Male and Female Facial Acne Scarring
United States10 participantsStarted 2020-10-30
Plain-language summary
This single-center, clinical trial consists of a one autologous fat grafting treatment followed by 3-month and 6-month post-treatment visits in order to assess the efficacy of fat grafting when used by men and women with facial acne scars.
Who can participate
Age range18 Years – 50 Years
SexALL
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Inclusion criteria
✓. Men and women 18 to 50 years of age having general good health.
✓. Individuals deemed by the Investigator to have a significant amount acne scarring on the face and that desire correction of this condition.
✓. Individuals willing to withhold aesthetic therapies to the areas of the hand being treated or judged to potentially impact results by the Investigator (e.g. soft tissue fillers and/or any resurfacing procedures, botulinum toxin, injectable fillers, microdermabrasion, IPL (intense pulsed light), peels, laser treatments, and tightening treatments, etc.) for the duration of the study. Waxing and threading is allowed but no laser treatments outside of the study.
✓. Individuals that are willing to provide written informed consent and are able to read, speak, write, and understand English.
✓. Individuals willing to sign a photography release.
✓. Willingness to cooperate and participate by following study requirements for the duration of the study and to report any changes in health status or medications, adverse event symptoms, or reactions immediately.
Exclusion criteria
✕. Individuals diagnosed with known allergies to general skin care products.
✕. Individuals who have presence of an active systemic or local skin disease that may affect wound healing.
✕. Individuals with sensitivity to topical lidocaine.
✕. Individuals who have physical or psychological conditions unacceptable to the Investigator.
What they're measuring
1
Subject Acne Severity Scale
Timeframe: Baseline
2
Facial Photograph Assessments- Global Aesthetic Improvement Scale
Timeframe: Month 3 and Month 6
3
Topographical Analysis of Texture
Timeframe: Baseline and 6 Months
4
Histological Analysis
Timeframe: Baseline, 3 Months and 6 Months
5
Gene Expression
Timeframe: Baseline, 3 Months and 6 Months
6
Topographical Analysis of Depressions
Timeframe: Baseline and 6 Months
Trial details
NCT IDNCT04559022
SponsorUniversity of Texas Southwestern Medical Center
✕. Individuals who have a recent history of significant trauma to the areas to be treated (\< 6 months).
✕. Individuals who have severe or cystic active and clinically significant acne on the area(s) to be treated. Clinically significant acne is defined as a subject whom has \> 5 active inflammatory acne lesions (including acne conglobate, nodules, or cysts) in either the right or left treatment area.
✕. Individuals who have a recent or current history of inflammatory skin disease, infection, unhealed wound or clinically significant acne in the proposed treatment areas.
✕. Individuals who have a history of systemic granulomatous diseases, active or inactive, (e.g. Sarcoid, Wegeners, TB, etc.) or connective tissue diseases (e.g. lupus, dermatomyositis, etc.).