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.
This investigation, pilot study will evaluate the safety and efficacy of autologous fat grafting for the treatment of acne scarring. Overall assessment of clinical outcome and safety will be based clinic visits and evaluation of pre- and post- procedural photos. In conjunction with standard and close-up photography, we will also be using 3D imaging, cross-polarized imaging, UV imaging, high-resolution ultrasonography, optical coherence tomography, transepidermal water loss measurements, and/or BTC 2000 measurements. Additionally, we will be utilizing 0.33 mm skin biopsies to assess histological and genetic changes that occur below the skin surface as a result of this treatment. The subject's assessment of satisfaction will be characterized using a non-parametric assessment scale at each follow-up period.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
This single-center, clinical trial will assess the efficacy and tolerability of the autologous fat grafting when used on men and women with acne scars on the face.
University of Texas Southwestern Medical Center
Dallas, Texas, United States
Subject Acne Severity Scale
The Goodman and Baron Qualitative Acne Scale will be used to assess acne scars. Grade 1- Macular Disease: Erythematous, hyper- or hypopigmented flat marks Grade 2- Mild Disease: Mild rolling, small soft papular Grade 3- Moderate Disease: More significant rolling, shallow "box car", mild to moderate hypertrophic or papular scars Garde 4- Severe disease: Punched out atrophic, "ice pick", bridges and tunnels, gross atrophy, dystrophic, scars significant hypertrophy or keloid
Time frame: Baseline
Facial Photograph Assessments- Global Aesthetic Improvement Scale
Subjects and Clinicians will evaluate efficacy of treatment at follow up visits. The photographs from follow up visits will be compared to their baseline photographs. Acne scars on patients will be assessed using the Global Aesthetic Improvement Scale by subject and clinician. CGAIS Rating 1. Very much improved: Optimal cosmetic result. 2. Much improved: Marked improvement in appearance from the initial condition, but not completely optimal. 3. Improved: Obvious improvement in appearance from initial condition. 4. No Change: The appearance is essentially the same as the original condition. 5. Worse: The appearance is worse than the original condition.
Time frame: Month 3 and Month 6
Topographical Analysis of Texture
MiraVex will be used to assess changes in texture (roughness) of the subjects facial acne scars.
Time frame: Baseline and 6 Months
Histological Analysis
Relative changes in protein abundance in biopsies taken at post treatment compare to control or entreated group will be quantified using an image processing software based on fluorescence signal intensity. The change from baseline was calculated at each time frame.
Time frame: Baseline, 3 Months and 6 Months
Gene Expression
Biopsies of the treated are will be taken prior to treatment and post treatment for gene expression analysis. This analysis will identify gene expression related to collagen formation and increased cell turnover.
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Time frame: Baseline, 3 Months and 6 Months
Topographical Analysis of Depressions
MiraVex will be used to assess changes in depressions of the subjects facial acne scars.
Time frame: Baseline and 6 Months
Noninvasive Skin Assessments- TEWL
Transepidermal Water Loss (TEWL) was measured at baseline and 6 months after treatment.
Time frame: Month 3 and Month 6
Noninvasive Skin Assessments- High-resolution Ultrasonography
Ultrasonography was used to measure epidermal/dermal thickness/density 3 and 6 months after treatment. Percent change from baseline results are reflected.
Time frame: Month 3 and Month 6
Noninvasive Skin Assessments- Skin Deformation
biomechanical analysis of skin deformation was used to measure skin laxity, skin elasticity, viscoelastic deformation, ultimate deformation, stiffness and energy absorption at 3 and 6 months after treatment. Percent change from baseline results are reflected.
Time frame: Month 3 and Month 6