Acne, Acne Scars - Mixed Atrophic and Hypertrophic
Conditions
Brief 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.
Detailed description
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.
Interventions
PROCEDUREFat Grafting
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.
Sponsors
University of Texas Southwestern Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
1. Men and women 18 to 50 years of age having general good health. 2. Individuals deemed by the Investigator to have a significant amount acne scarring on the face and that desire correction of this condition. 3. 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. 4. Individuals that are willing to provide written informed consent and are able to read, speak, write, and understand English. 5. Individuals willing to sign a photography release. 6. 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
1. Individuals diagnosed with known allergies to general skin care products. 2. Individuals who have presence of an active systemic or local skin disease that may affect wound healing. 3. Individuals with sensitivity to topical lidocaine. 4. Individuals who have physical or psychological conditions unacceptable to the Investigator. 5. Individuals who have a recent history of significant trauma to the areas to be treated (\< 6 months). 6. 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. 7. Individuals who have a recent or current history of inflammatory skin disease, infection, unhealed wound or clinically significant acne in the proposed treatment areas. 8. 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.). 9. Individuals who currently have or have a history of hypertrophic scars, or keloid scars. 10. Individuals who currently have cancerous or pre-cancerous lesions in the areas to be treated and/or with a history of skin cancer. 11. Individuals who have the inability to understand instructions or to give informed consent. 12. 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. 13. Individuals who have a history of chronic drug or alcohol abuse. 14. Individuals undergoing concurrent therapy that, in the Investigator's opinion, would interfere with the evaluation of the safety or efficacy of the study device. 15. Individuals who, in the Investigator's opinion, have a history of poor cooperation, noncompliance with medical treatment, or unreliability. 16. 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 17. 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.) within four months; * Any anti-wrinkle, skin lightening devices, or any other device or topical or systemic medication known to affect skin aging or dyshcromia (devices containing alpha/beta/poly-hydroxy acids, vitamin C, soy, Q-10, hydroquinone; systemic or licorice extract (topically), Tego® Cosmo C250, gigawhite, lemon juice extract (topically), emblica extract, etc.) within two weeks; * Antiplatelet agents/Anticoagulants (Coumadin, Heparin, Plavix, chronic NSAID use); and/or * Psychiatric drugs that in the Investigator's opinion would impair the subject from understanding the protocol requirements or understanding and signing the informed consent. 18. Individuals who are nursing, pregnant, or planning to become pregnant during the study according to subject self-report. 19. Individuals having a health condition and/or pre-existing or dormant dermatologic disease on the body (e.g., psoriasis, rosacea, eczema, seborrheic dermatitis, vitiligo, hyper or hypo-skin pigmentation conditions such as post inflammatory hyperpigmentation) that the Investigator or designee deems inappropriate for participation or could interfere with the outcome of the study. 20. Individuals with a history of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or currently using immunosuppressive medications (e.g., azathioprine, belimumab, cyclophosphamide, Enbrel, Imuran, Humira, mycophenolate mofetil, methotrexate, prednisone, Remicade, Stelara.) and/or radiation as determined by study documentation. 21. Individuals with an uncontrolled disease such as asthma, diabetes, hyperthyroidism, medically significant hypertension or hypothyroidism. Individuals having multiple health conditions may be excluded from participation even if the conditions are controlled by diet, medication, etc. 22. Individuals with any planned surgeries, overnight hospitalization, and/or invasive medical procedures during the course of the study. 23. Individuals who have observable suntan, nevi, excessive hair, etc. or other dermal conditions on the back of the hand that might influence the test results in the opinion of the Investigator or designee. 24. Individuals who have any condition, which in the opinion of the Investigator makes the patient unable to complete the study per protocol (e.g. patients not likely to avoid other cosmetic treatments to the treatment area; patients not likely to stay in the study for its duration because of other commitments, concomitant conditions, or past history; patients anticipated to be unreliable, or patients who have a concomitant condition that may develop symptoms that might confuse or confound study treatments or assessments).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Topographical Analysis of Depressions | Baseline and 6 Months | MiraVex will be used to assess changes in depressions of the subjects facial acne scars. |
| Topographical Analysis of Texture | Baseline and 6 Months | MiraVex will be used to assess changes in texture (roughness) of the subjects facial acne scars. |
| Histological Analysis | Baseline, 3 Months and 6 Months | 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. |
| Gene Expression | Baseline, 3 Months and 6 Months | 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. |
| Subject Acne Severity Scale | Baseline | 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 |
| Facial Photograph Assessments- Global Aesthetic Improvement Scale | Month 3 and Month 6 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Noninvasive Skin Assessments- High-resolution Ultrasonography | Month 3 and Month 6 | Ultrasonography was used to measure epidermal/dermal thickness/density 3 and 6 months after treatment. Percent change from baseline results are reflected. |
| Noninvasive Skin Assessments- Skin Deformation | Month 3 and Month 6 | 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. |
| Noninvasive Skin Assessments- TEWL | Month 3 and Month 6 | Transepidermal Water Loss (TEWL) was measured at baseline and 6 months after treatment. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Fat Grafting for Acne Scar Treatment 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.
Fat Grafting: 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. | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | Fat Grafting for Acne Scar Treatment |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 8 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Fitzpatrick Skin Score Type 1 | 0 Participants |
| Fitzpatrick Skin Score Type 2 | 6 Participants |
| Fitzpatrick Skin Score Type 3 | 1 Participants |
| Fitzpatrick Skin Score Type 4 | 3 Participants |
| Fitzpatrick Skin Score Type 5 | 0 Participants |
| Fitzpatrick Skin Score Type 6 | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 9 Participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 10 |
| other Total, other adverse events | 1 / 10 |
| serious Total, serious adverse events | 0 / 10 |
Outcome results
Primary
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
| Arm | Measure | Group | Value (MEDIAN) | Dispersion |
|---|---|---|---|---|
| Fat Grafting for Acne Scar Treatment | Facial Photograph Assessments- Global Aesthetic Improvement Scale | Month 3 | 2.7 units on a scale | Standard Error 0.36 |
| Fat Grafting for Acne Scar Treatment | Facial Photograph Assessments- Global Aesthetic Improvement Scale | Month 6 | 2.8 units on a scale | Standard Error 0.26 |
| Clinician Assessment | Facial Photograph Assessments- Global Aesthetic Improvement Scale | Month 3 | 3 units on a scale | Standard Error 0.37 |
| Clinician Assessment | Facial Photograph Assessments- Global Aesthetic Improvement Scale | Month 6 | 3.2 units on a scale | Standard Error 0.25 |
Primary
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.
Time frame: Baseline, 3 Months and 6 Months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fat Grafting for Acne Scar Treatment | Gene Expression | Month 6 | 0.58 percentage change from baseline | Standard Error 0.13 |
| Fat Grafting for Acne Scar Treatment | Gene Expression | Month 3 | 1.48 percentage change from baseline | Standard Error 0.83 |
| Fat Grafting for Acne Scar Treatment | Gene Expression | Baseline | 1.13 percentage change from baseline | Standard Error 0.2 |
| Clinician Assessment | Gene Expression | Month 3 | 1.68 percentage change from baseline | Standard Error 1 |
| Clinician Assessment | Gene Expression | Baseline | 1.21 percentage change from baseline | Standard Error 0.34 |
| Clinician Assessment | Gene Expression | Month 6 | 0.58 percentage change from baseline | Standard Error 0.12 |
| Reticular Dermis- Type I Collagen | Gene Expression | Month 6 | 0.59 percentage change from baseline | Standard Error 0.27 |
| Reticular Dermis- Type I Collagen | Gene Expression | Baseline | 1.31 percentage change from baseline | Standard Error 0.49 |
| Reticular Dermis- Type I Collagen | Gene Expression | Month 3 | 0.45 percentage change from baseline | Standard Error 0.19 |
| Reticular Dermis- Type III Collagen | Gene Expression | Month 3 | 0.69 percentage change from baseline | Standard Error 0.32 |
| Reticular Dermis- Type III Collagen | Gene Expression | Baseline | 1.46 percentage change from baseline | Standard Error 0.58 |
| Reticular Dermis- Type III Collagen | Gene Expression | Month 6 | 0.53 percentage change from baseline | Standard Error 0.12 |
| Matrix Metalloproteinase-2 | Gene Expression | Month 3 | 0.66 percentage change from baseline | Standard Error 0.28 |
| Matrix Metalloproteinase-2 | Gene Expression | Baseline | 1.17 percentage change from baseline | Standard Error 0.24 |
| Matrix Metalloproteinase-2 | Gene Expression | Month 6 | 0.43 percentage change from baseline | Standard Error 0.12 |
| Tissue Growth Factor B1 | Gene Expression | Baseline | 1.19 percentage change from baseline | Standard Error 0.32 |
| Tissue Growth Factor B1 | Gene Expression | Month 6 | 0.61 percentage change from baseline | Standard Error 0.12 |
| Tissue Growth Factor B1 | Gene Expression | Month 3 | 0.65 percentage change from baseline | Standard Error 0.07 |
| Tissue Growth Factor B3 | Gene Expression | Month 6 | 0.56 percentage change from baseline | Standard Error 0.14 |
| Tissue Growth Factor B3 | Gene Expression | Month 3 | 0.40 percentage change from baseline | Standard Error 0.01 |
| Tissue Growth Factor B3 | Gene Expression | Baseline | 1.37 percentage change from baseline | Standard Error 0.55 |
Primary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fat Grafting for Acne Scar Treatment | Histological Analysis | Baseline | 1.00 percentage change from baseline | Standard Error 0.09 |
| Fat Grafting for Acne Scar Treatment | Histological Analysis | Month 6 | 0.85 percentage change from baseline | Standard Error 0.05 |
| Fat Grafting for Acne Scar Treatment | Histological Analysis | Month 3 | 1.07 percentage change from baseline | Standard Error 0.13 |
| Clinician Assessment | Histological Analysis | Baseline | 1.00 percentage change from baseline | Standard Error 0.25 |
| Clinician Assessment | Histological Analysis | Month 6 | 0.76 percentage change from baseline | Standard Error 0.15 |
| Clinician Assessment | Histological Analysis | Month 3 | 0.87 percentage change from baseline | Standard Error 0.24 |
| Reticular Dermis- Type I Collagen | Histological Analysis | Month 3 | 0.76 percentage change from baseline | Standard Error 0.1 |
| Reticular Dermis- Type I Collagen | Histological Analysis | Baseline | 1.0 percentage change from baseline | Standard Error 0.18 |
| Reticular Dermis- Type I Collagen | Histological Analysis | Month 6 | 0.85 percentage change from baseline | Standard Error 0.06 |
| Reticular Dermis- Type III Collagen | Histological Analysis | Baseline | 1.0 percentage change from baseline | Standard Error 0.26 |
| Reticular Dermis- Type III Collagen | Histological Analysis | Month 6 | 0.62 percentage change from baseline | Standard Error 0.13 |
| Reticular Dermis- Type III Collagen | Histological Analysis | Month 3 | 0.74 percentage change from baseline | Standard Error 0.08 |
Primary
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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Fat Grafting for Acne Scar Treatment | Subject Acne Severity Scale | Grade 1: Macular | 0 Participants |
| Fat Grafting for Acne Scar Treatment | Subject Acne Severity Scale | Grade 2: Mild | 1 Participants |
| Fat Grafting for Acne Scar Treatment | Subject Acne Severity Scale | Grade 3: Moderate | 2 Participants |
| Fat Grafting for Acne Scar Treatment | Subject Acne Severity Scale | Grade 4: Severe | 7 Participants |
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fat Grafting for Acne Scar Treatment | Topographical Analysis of Depressions | 11.45 mm^3 | Standard Error 2.36 |
| Clinician Assessment | Topographical Analysis of Depressions | 10.64 mm^3 | Standard Error 2.4 |
Primary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fat Grafting for Acne Scar Treatment | Topographical Analysis of Texture | Maximum Depth of Depressions (mm) | 0.1495 mm | Standard Error 0.019 |
| Fat Grafting for Acne Scar Treatment | Topographical Analysis of Texture | Roughness (Ra) | 17.55 mm | Standard Error 1.5 |
| Clinician Assessment | Topographical Analysis of Texture | Maximum Depth of Depressions (mm) | 0.0536 mm | Standard Error 0.017 |
| Clinician Assessment | Topographical Analysis of Texture | Roughness (Ra) | 16.58 mm | Standard Error 1.6 |
Secondary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fat Grafting for Acne Scar Treatment | Noninvasive Skin Assessments- High-resolution Ultrasonography | Epidermal Thickness | -4.28 percentage change from baseline | Standard Deviation 12.37 |
| Fat Grafting for Acne Scar Treatment | Noninvasive Skin Assessments- High-resolution Ultrasonography | Epidermal Density | 21.34 percentage change from baseline | Standard Deviation 22.05 |
| Fat Grafting for Acne Scar Treatment | Noninvasive Skin Assessments- High-resolution Ultrasonography | Dermal Thickness | -26.4 percentage change from baseline | Standard Deviation 212.46 |
| Fat Grafting for Acne Scar Treatment | Noninvasive Skin Assessments- High-resolution Ultrasonography | Dermal Density | 53.5 percentage change from baseline | Standard Deviation 11.248 |
| Clinician Assessment | Noninvasive Skin Assessments- High-resolution Ultrasonography | Dermal Density | -12.9 percentage change from baseline | Standard Deviation 5.41 |
| Clinician Assessment | Noninvasive Skin Assessments- High-resolution Ultrasonography | Epidermal Thickness | -0.63 percentage change from baseline | Standard Deviation 10.98 |
| Clinician Assessment | Noninvasive Skin Assessments- High-resolution Ultrasonography | Dermal Thickness | -19.4 percentage change from baseline | Standard Deviation 330.59 |
| Clinician Assessment | Noninvasive Skin Assessments- High-resolution Ultrasonography | Epidermal Density | -2.9 percentage change from baseline | Standard Deviation 11.96 |
Secondary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fat Grafting for Acne Scar Treatment | Noninvasive Skin Assessments- Skin Deformation | Ultimate Deformation | -6.90 percentage change from baseline | Standard Deviation 0.25 |
| Fat Grafting for Acne Scar Treatment | Noninvasive Skin Assessments- Skin Deformation | Skin Elasticity | 7.36 percentage change from baseline | Standard Deviation 0.18 |
| Fat Grafting for Acne Scar Treatment | Noninvasive Skin Assessments- Skin Deformation | Stiffness | -1.53 percentage change from baseline | Standard Deviation 46.22 |
| Fat Grafting for Acne Scar Treatment | Noninvasive Skin Assessments- Skin Deformation | Viscoelastic Deformation | 3.57 percentage change from baseline | Standard Deviation 0.03 |
| Fat Grafting for Acne Scar Treatment | Noninvasive Skin Assessments- Skin Deformation | Energy Absorption | -2.35 percentage change from baseline | Standard Deviation 11.3 |
| Fat Grafting for Acne Scar Treatment | Noninvasive Skin Assessments- Skin Deformation | Skin Laxity | -5.88 percentage change from baseline | Standard Deviation 0.33 |
| Clinician Assessment | Noninvasive Skin Assessments- Skin Deformation | Energy Absorption | -6.07 percentage change from baseline | Standard Deviation 0.82 |
| Clinician Assessment | Noninvasive Skin Assessments- Skin Deformation | Skin Laxity | -5.16 percentage change from baseline | Standard Deviation 0.36 |
| Clinician Assessment | Noninvasive Skin Assessments- Skin Deformation | Viscoelastic Deformation | 2.38 percentage change from baseline | Standard Deviation 0.34 |
| Clinician Assessment | Noninvasive Skin Assessments- Skin Deformation | Ultimate Deformation | -11.61 percentage change from baseline | Standard Deviation 0.35 |
| Clinician Assessment | Noninvasive Skin Assessments- Skin Deformation | Stiffness | 4.05 percentage change from baseline | Standard Deviation 49.68 |
| Clinician Assessment | Noninvasive Skin Assessments- Skin Deformation | Skin Elasticity | -5.62 percentage change from baseline | Standard Deviation 0.34 |
Secondary
Noninvasive Skin Assessments- TEWL
Transepidermal Water Loss (TEWL) was measured at baseline and 6 months after treatment.
Time frame: Month 3 and Month 6
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fat Grafting for Acne Scar Treatment | Noninvasive Skin Assessments- TEWL | 8.74 percentage change from baseline | Standard Deviation 3.41 |
| Clinician Assessment | Noninvasive Skin Assessments- TEWL | 35.37 percentage change from baseline | Standard Deviation 11.18 |