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| Name | Class |
|---|---|
| ethica Clinical Research Inc. | INDUSTRY |
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This is an open-label, randomized, multicenter, prospective trial assessing the efficacy and safety of microneedling treatment alone vs. microneedling treatment followed by treatment with Bellafill for correction of distensible atrophic facial acne scars.
The study is divided into two study Periods. In Period I, subjects will attend a Screening visit (Week -4) and undergo the Bellafill skin test. At Visit 1 (Day 0), all subjects will commence microneedling treatment for their atrophic acne scars. Subjects will then return to the clinic at Week 3 and Week 6 (Visits 2 and 3, respectively) for follow-up evaluation and additional cycles of microneedling treatment.
At Week 12 (Visit 4), all subjects commence Period II and are randomized to Bellafill Treatment (Track A) or to No Treatment (Track B):
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Microneedling Only | Experimental | All eligible scars within the treatment areas on each side of the face will receive microneedling treatment. The device will be rolled in a horizontal direction with medium pressure. After every roll, the device will be lifted and positioned a few millimeters inferior to the previous starting point. Rolling will be repeated until the entire skin area has been treated. The device will then be reoriented vertically and rolling will be repeated in a vertical direction. |
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| Microneedling followed by Bellafill treatment | Experimental | Subjects undergo microneedling as described for the Microneedling Only group. Then at Week 12, all eligible scars within the treatment areas on each side of the face will be treated with Bellafill (injected using a standard tunneling technique). A touch-up treatment is allowed at Month 1 after initial treatment, if additional treatment is required to achieve optimal correction. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Microneedling | Procedure |
| ||
| Microneedling followed by Bellafill treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Acne Scar Assessment Scale (ASAS) | • Acne Scar Assessment Scale (ASAS): a validated 5-point static scale assessing physician impression of acne scar severity where as 1=clear and 5 = severe | 6 months post-injection for Bellafill arm. 3 months Microneedling alone arm |
| Physician Global Aesthetic Improvement Scale (PGAIS) | The PGAIS is used for the physician to rate the improvement of the acne scar. 5 point Likert Scale ranging from 5 to 1 with 5 = Much Improved and 1 = Much Worse | From week 12 to 6-months for the Treatment arm and 3 months for the Microneedling only arm |
| Subject Global Aesthetic Improvement Scale (SGAIS) | The SGAIS is used for the subject to rate the improvement of the acne scar. 5 point Likert Scale ranging from 5 to 1 with 5 = Much Improved and 1 = Much Worse | From week 12 to 6-months for the Treatment arm and 3 months for the Microneedling only arm |
| Quality of Life Impact Scar (QOLIS) | Quality of Life Scar Impact Scale questionnaire was used to allow the subject to specifically address how acne scarring has affected his/her emotional and functional status. Subjects completed 33 questions ratings between 1 and 7 one being less severe 4 neutral and 7 more severe. Scores are averaged for a total range of 1-7. | 6-months for the Treatment arm and 3 months for the Microneedling only arm |
| Number of Subjects With Adverse Events | 6-months |
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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 | Nashville | Tennessee | 37203 | United States |
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55 subjects screened with 45 meeting eligibility criteria and enrolled. One subject discontinued by investigator. 44 subjects randomized 23 to Microneedling + Bellafill and 21 to Microneedling alone.
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| ID | Title | Description |
|---|---|---|
| FG000 | Microneedling Only | All subjects eligible scars within the treatment areas on each side of the face will receive microneedling treatment. At Week 12 subjects randomized to no further treatment. |
| FG001 | Microneedling Followed by Bellafill Treatment | All Subjects undergo microneedling as described for the Microneedling Only group. Then at Week 12, all eligible scars within the treatment areas on each side of the face will be treated with Bellafill (injected using a standard tunneling technique). A touch-up treatment is allowed at Month 1 after initial treatment, if additional treatment is required to achieve optimal correction. Microneedling followed by Bellafill treatment |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Microneedling Only | All eligible scars within the treatment areas on each side of the face will receive microneedling treatment. Subjects randomized at week 12 to no further treatment. |
| BG001 | Microneedling Followed by Bellafill Treatment |
| 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 | Acne Scar Assessment Scale (ASAS) | • Acne Scar Assessment Scale (ASAS): a validated 5-point static scale assessing physician impression of acne scar severity where as 1=clear and 5 = severe | All subjects | Posted | Mean | Standard Deviation | units on a scale | 6 months post-injection for Bellafill arm. 3 months Microneedling alone arm |
|
six (6) 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 | Microneedling Followed by Bellafill Treatment | Subjects undergo microneedling as described for the Microneedling Only group. Then at Week 12, all eligible scars within the treatment areas on each side of the face will be treated with Bellafill (injected using a standard tunneling technique). A touch-up treatment is allowed at Month 1 after initial treatment, if additional treatment is required to achieve optimal correction. Microneedling followed by Bellafill treatment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Treatment Site Dermatitis | Skin and subcutaneous tissue disorders | Systematic Assessment | Treatment Site Dermatitis was attributed to the microneedling procedure. |
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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 |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 11, 2015 | Apr 24, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000097244 | Percutaneous Collagen Induction |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D011677 | Punctures |
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| Device |
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| Relocated out of state |
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Subjects undergo microneedling as described for the Microneedling Only group. Then at Week 12, all eligible scars within the treatment areas on each side of the face will be treated with Bellafill (injected using a standard tunneling technique). A touch-up treatment is allowed at Month 1 after initial treatment, if additional treatment is required to achieve optimal correction. Microneedling followed by Bellafill treatment |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 |
| Microneedling Only |
All eligible scars within the treatment areas on each side of the face will receive microneedling treatment. The device will be rolled in a horizontal direction with medium pressure. After every roll, the device will be lifted and positioned a few millimeters inferior to the previous starting point. Rolling will be repeated until the entire skin area has been treated. The device will then be reoriented vertically and rolling will be repeated in a vertical direction. Microneedling |
|
|
| Primary | Physician Global Aesthetic Improvement Scale (PGAIS) | The PGAIS is used for the physician to rate the improvement of the acne scar. 5 point Likert Scale ranging from 5 to 1 with 5 = Much Improved and 1 = Much Worse | There were 21 subjects in the microneedling arm however data only available for 19 subjects | Posted | Mean | Standard Deviation | units on a scale | From week 12 to 6-months for the Treatment arm and 3 months for the Microneedling only arm |
|
|
|
| Primary | Subject Global Aesthetic Improvement Scale (SGAIS) | The SGAIS is used for the subject to rate the improvement of the acne scar. 5 point Likert Scale ranging from 5 to 1 with 5 = Much Improved and 1 = Much Worse | There were 21 subjects in the microneedling arm however data only available for 19 subjects | Posted | Mean | Standard Deviation | units on a scale | From week 12 to 6-months for the Treatment arm and 3 months for the Microneedling only arm |
|
|
|
| Primary | Quality of Life Impact Scar (QOLIS) | Quality of Life Scar Impact Scale questionnaire was used to allow the subject to specifically address how acne scarring has affected his/her emotional and functional status. Subjects completed 33 questions ratings between 1 and 7 one being less severe 4 neutral and 7 more severe. Scores are averaged for a total range of 1-7. | Posted | Mean | Standard Deviation | units on a scale | 6-months for the Treatment arm and 3 months for the Microneedling only arm |
|
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| Primary | Number of Subjects With Adverse Events | Posted | Count of Participants | Participants | 6-months |
|
|
|
| 0 |
| 23 |
| 0 |
| 23 |
| 2 |
| 23 |
| EG001 | Microneedling Only | All eligible scars within the treatment areas on each side of the face will receive microneedling treatment. The device will be rolled in a horizontal direction with medium pressure. After every roll, the device will be lifted and positioned a few millimeters inferior to the previous starting point. Rolling will be repeated until the entire skin area has been treated. The device will then be reoriented vertically and rolling will be repeated in a vertical direction. Microneedling | 0 | 21 | 0 | 21 | 1 | 21 |
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| Peripheral edema of the foot | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| slight cold | Immune system disorders | Systematic Assessment | Subject had a slight cold |
|
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| D012046 |
| Rehabilitation |