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| Name | Class |
|---|---|
| ethica Clinical Research Inc. | INDUSTRY |
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This is an open-label, multicenter, prospective pilot study assessing the efficacy and safety of Bellafill for correction of distensible atrophic acne scars in the full facial area. All enrolled subjects will receive initial treatment with Bellafill, as well as touch-up treatments (if necessary to achieve optimal correction). Subjects will be evaluated at Screening (Month -1), Day 0 (Baseline) Month 1, Month 4, and Month 7.
Correctable acne scars will be individually identified and only scars that the Investigator determines to be correctable will receive study treatment. All eligible scars within the treatment area will be treated.
Bellafill should be injected using a standard tunneling technique whereby the filler is injected in a retrograde manner utilizing several passes until the scar reaches a desired
level of correction. A touch-up treatment is allowed if additional treatment is required to achieve optimal correction.
Treatment Area
There will be four "quadrants" of the face where treatment is allowed and grading will occur. The glabellar, nose and upper lip areas are not to be treated:
Each quadrant will be graded individually and receive a separate grade. The no treatment zones of the glabella, nose and upper lip should be respected as they have been selected to maximize the safety of the subject. A "touch-up treatment" is permitted at study Visit 3 (Month 1). The Investigator will evaluate each lesion and determine if a treated scar is undercorrected and whether additional improvement could be obtained with a touch-up treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bellafill Injections | Experimental | Correctable acne scars will be individually identified and only scars that the Investigator determines to be correctable will receive study treatment. All eligible scars within the treatment area will be treated. Bellafill will be injected using a standard tunneling technique whereby the filler is injected in a retrograde manner utilizing several passes until the scar reaches a desired level of correction. A touch-up treatment is allowed if additional treatment is required to achieve optimal correction. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bellafill | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change on the Acne Scar Assessment Scale (ASAS) | A validated 5-point static scale assessing physician impression of acne scar severity. The total range on the scale is 1-5 (1= Clear and 5 = Severe) Clear: No depressions are seen in the treatment area. Macular discoloration may be seen. Very Mild: A single depression is easily noticeable with direct lighting (deep). Most or all of the depressions seen are only readily apparent with tangential lighting (shallow). Mild: A few to several, but less than half of all the depressions are easily noticeable with direct lighting (deep). Most of the depressions seen are only readily apparent with tangential lighting (shallow). Moderate: More than half of the depressions are apparent with direct lighting (deep). Severe: All or almost all the lesions can be seen with direct lighting (deep) | Month 1, 4 and 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | Throughout the course of the study, all AEs will be monitored and reported through the CRF. All AEs occurring after study device administration were followed until the event has resolved or stabilized or until follow-up was no longer possible. | month 7 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nancy Seretta | Suneva Medical | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Call Suneva for Info | Houston | Texas | 77494 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30829754 | Derived | Joseph JH, Shamban A, Eaton L, Lehman A, Cohen S, Spencer J, Bruce S, Grimes P, Tedaldi R, Callender V, Werschler P. Polymethylmethacrylate Collagen Gel-Injectable Dermal Filler for Full Face Atrophic Acne Scar Correction. Dermatol Surg. 2019 Dec;45(12):1558-1566. doi: 10.1097/DSS.0000000000001863. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Bellafill Injections | Correctable acne scars will be individually identified and only scars that the Investigator determines to be correctable will receive study treatment. All eligible scars within the treatment area will be treated. Bellafill will be injected using a standard tunneling technique whereby the filler is injected in a retrograde manner utilizing several passes until the scar reaches a desired level of correction. A touch-up treatment is allowed if additional treatment is required to achieve optimal correction. Bellafill |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Bellafill Injections | Correctable acne scars will be individually identified and only scars that the Investigator determines to be correctable will receive study treatment. All eligible scars within the treatment area will be treated. Bellafill will be injected using a standard tunneling technique whereby the filler is injected in a retrograde manner utilizing several passes until the scar reaches a desired level of correction. A touch-up treatment is allowed if additional treatment is required to achieve optimal correction. Bellafill |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Change on the Acne Scar Assessment Scale (ASAS) | A validated 5-point static scale assessing physician impression of acne scar severity. The total range on the scale is 1-5 (1= Clear and 5 = Severe) Clear: No depressions are seen in the treatment area. Macular discoloration may be seen. Very Mild: A single depression is easily noticeable with direct lighting (deep). Most or all of the depressions seen are only readily apparent with tangential lighting (shallow). Mild: A few to several, but less than half of all the depressions are easily noticeable with direct lighting (deep). Most of the depressions seen are only readily apparent with tangential lighting (shallow). Moderate: More than half of the depressions are apparent with direct lighting (deep). Severe: All or almost all the lesions can be seen with direct lighting (deep) | The overall number of participants was all subjects enrolled in the clinical trial. The number analyzed includes the number of participants with available data for each time point. | Posted | Mean | Standard Deviation | units on a scale | Month 1, 4 and 7 |
|
7 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 | Bellafill Injections | Correctable acne scars will be individually identified and only scars that the Investigator determines to be correctable will receive study treatment. All eligible scars within the treatment area will be treated. Bellafill will be injected using a standard tunneling technique whereby the filler is injected in a retrograde manner utilizing several passes until the scar reaches a desired level of correction. A touch-up treatment is allowed if additional treatment is required to achieve optimal correction. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bruising | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Affairs | Suneva Medical | 858-324-6268 | alehman@sunevamedical.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Oct 5, 2015 | Apr 2, 2020 | ICF_000.pdf |
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 28, 2015 | Apr 2, 2020 | Prot_SAP_001.pdf |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG000 | Bellafill Injections | Correctable acne scars will be individually identified and only scars that the Investigator determines to be correctable will receive study treatment. All eligible scars within the treatment area will be treated. Bellafill will be injected using a standard tunneling technique whereby the filler is injected in a retrograde manner utilizing several passes until the scar reaches a desired level of correction. A touch-up treatment is allowed if additional treatment is required to achieve optimal correction. Bellafill |
|
|
| Secondary | Adverse Events | Throughout the course of the study, all AEs will be monitored and reported through the CRF. All AEs occurring after study device administration were followed until the event has resolved or stabilized or until follow-up was no longer possible. | Posted | Number | adverse events | month 7 |
|
|
|
| 0 |
| 42 |
| 0 |
| 42 |
| 6 |
| 42 |
| Injection Site hemorrhage (Skin Test) | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Injection Site Pain | General disorders | MedDRA (10.0) | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Contact Dermatitis | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
|
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