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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fat Grafting for Acne Scar Treatment | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fat Grafting | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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
| 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. | 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. | Baseline, 3 Months and 6 Months |
| Gene Expression |
| Measure | Description | Time Frame |
|---|---|---|
| Noninvasive Skin Assessments- TEWL | Transepidermal Water Loss (TEWL) was measured at baseline and 6 months after treatment. | Month 3 and Month 6 |
| Noninvasive Skin Assessments- High-resolution Ultrasonography |
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Inclusion Criteria:
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 (< 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.).
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:
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:
Individuals who are nursing, pregnant, or planning to become pregnant during the study according to subject self-report.
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.
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.
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.
Individuals with any planned surgeries, overnight hospitalization, and/or invasive medical procedures during the course of the study.
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.
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).
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey Kenkel, MD | UT Southwestern | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Count of Participants | Participants | Baseline |
|
18 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Covid | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Research Coordinator | UT Southwestern | 2146458907 | jennifer.barillas@utsouthwestern.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 21, 2021 | Apr 13, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006984 | Hypertrophy |
| D000152 | Acne Vulgaris |
| ID | Term |
|---|---|
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D017486 | Acneiform Eruptions |
| D012871 | Skin Diseases |
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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.
| 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. | Baseline and 6 Months |
Ultrasonography was used to measure epidermal/dermal thickness/density 3 and 6 months after treatment.
Percent change from baseline results are reflected.
| 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. | Month 3 and Month 6 |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Fitzpatrick Skin Score | The Fitzpatrick scale is a numerical classification schema for human skin color to estimate response of skin to UV light. Fitzpatrick type & Characteristics
| Count of Participants | Participants |
|
|
|
| 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
| Posted | Median | Standard Error | units on a scale | Month 3 and Month 6 |
|
|
|
| Primary | Topographical Analysis of Texture | MiraVex will be used to assess changes in texture (roughness) of the subjects facial acne scars. | Posted | Mean | Standard Error | mm | Baseline and 6 Months |
|
|
|
| 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. | Posted | Mean | Standard Error | percentage change from baseline | Baseline, 3 Months and 6 Months |
|
|
|
| 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. | Posted | Mean | Standard Error | percentage change from baseline | Baseline, 3 Months and 6 Months |
|
|
|
| Secondary | Noninvasive Skin Assessments- TEWL | Transepidermal Water Loss (TEWL) was measured at baseline and 6 months after treatment. | Posted | Mean | Standard Deviation | percentage change from baseline | Month 3 and Month 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. | Posted | Mean | Standard Deviation | percentage change from baseline | Month 3 and Month 6 |
|
|
|
| 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. | Posted | Mean | Standard Deviation | percentage change from baseline | Month 3 and Month 6 |
|
|
|
| Primary | Topographical Analysis of Depressions | MiraVex will be used to assess changes in depressions of the subjects facial acne scars. | Posted | Mean | Standard Error | mm^3 | Baseline and 6 Months |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 1 |
| 10 |
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| D017437 | Skin and Connective Tissue Diseases |
| D012625 | Sebaceous Gland Diseases |
| Month 3 |
|
| Month 6 |
|
| Month 3 |
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| Month 6 |
|
| Dermal Thickness |
|
| Dermal Density |
|
| Viscoelastic Deformation |
|
| Ultimate Deformation |
|
| Stiffness |
|
| Energy Absorption |
|