N/A
N=10
Pilot Study Investigating the Efficacy of Fat Grafting as a Treatment for Male and Female Facial Acne Scarring
Acne Scars - Mixed Atrophic and Hypertrophic · Acne
Bottom Line
View on ClinicalTrials.gov: NCT04559022 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Oct 2024
Primary outcome: Primary: Subject Acne Severity Scale — 0; 1; 2; 7 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Fat Grafting (Procedure)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Texas Southwestern Medical Center
- Primary completion
- Jun 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Subject Acne Severity Scale |
0; 1; 2; 7 | — |
| PRIMARY Facial Photograph Assessments- Global Aesthetic Improvement Scale |
2.7; 3; 2.8; 3.2 | — |
| PRIMARY Topographical Analysis of Texture |
0.1495; 0.0536; 17.55; 16.58 | — |
| PRIMARY Histological Analysis |
1.00; 1.00; 1.0; 1.0; 1.07; 0.87 | — |
| PRIMARY Gene Expression |
1.13; 1.21; 1.31; 1.46; 1.17; 1.19 | — |
| PRIMARY Topographical Analysis of Depressions |
11.45; 10.64 | — |
| SECONDARY Noninvasive Skin Assessments- TEWL |
8.74; 35.37 | — |
| SECONDARY Noninvasive Skin Assessments- High-resolution Ultrasonography |
-4.28; -0.63; 21.34; -2.9; -26.4; -19.4 | — |
| SECONDARY Noninvasive Skin Assessments- Skin Deformation |
-5.88; -5.16; 7.36; -5.62; 3.57; 2.38 | — |
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.
Eligibility Criteria
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.
- Individuals who have a recent history of significant trauma to the areas to be treated ( 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.).
- Individuals who currently have or have a history of hypertrophic scars, or keloid scars.
- Individuals who currently have cancerous or pre-cancerous lesions in the areas to be treated and/or with a history of skin cancer.
- Individuals who have the inability to understand instructions or to give informed consent.
- Individuals who have had microdermabrasion or glycolic acid treatment to the treatment area(s) within one month prior to study participation or who will have this treatment during the study.
- Individuals who have a history of chronic drug or alcohol abuse.
- Individuals undergoing concurrent therapy that, in the Investigator's opinion, would interfere with the evaluation of the safety or efficacy of the study device.
- Individuals who, in the Investigator's opinion, have a history of poor cooperation, noncompliance with medical treatment, or unreliability.
- Individuals who have a history of the following cosmetic treatments in the area(s) to be treated:
- Skin tightening procedure within the past year;
- Injectable filler of any type within the past:
- 12 months for Hyaluronic acid fillers (e.g. Restylane)
- 12 months for Ca Hydroxyapatite fillers (e.g. Radiesse)
- 24 months for Poly-L-Lactic acid fillers (e.g. Sculptra)
- Ever for permanent fillers (e.g. Silicone, ArteFill)
- Neurotoxins within the past three months;
- Ablative resurfacing laser treatment;
- Non-ablative, rejuvenative laser or light treatment within the past six months;
- Surgical dermabrasion;
- Had a chemical peel or dermabrasion, of the dorsum of the hand within four weeks
- Individuals with a history of using the following prescription medications:
- Accutane or other systemic retinoids within the past six months;
- Topical Retinoids within the past two weeks;
- Prescription strength skin lightening devices (e.g. hydroquinone, tretinoin, AHA, BHA and polyhydroxy acids, 4-hydroxyanisole alone or in combination with tretinoin, etc
Data sourced from ClinicalTrials.gov (NCT04559022). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.