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This single-center, clinical trial will take place over a 90 day course followed by 1-month and 6-month post treatment visits to assess the efficacy and tolerability of the SkinPen device when used on both men and women on the face and/or back.
At least 20 subjects of varying Fitzpatrick skin types will be admitted to the trial for treatment on their moderate to severe acne scars on the face and/or back. Implementation of needle depths ranging from 0.25 mm to 2.0 mm will depend on severity of scars and their location. Each subject will undergo 3 treatments in 30 day increments and will take pre-treatment images as well as 1-month and 6-months post treatment images. Assessment will be based on the Goodman and Baron's grading system, the Clinician's Global Aesthetic Improvement Scale, as well as a self-assessment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SkinPen II | Active Comparator | Three treatments using SkinPen II aesthetic microneedling device to each patient, with each treatment spaced one month apart. |
|
| SkinPen Precision | Active Comparator | Three treatments using SkinPen Precision aesthetic microneedling device to each patient, with each treatment spaced one month apart. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aesthetic Microneedling Treatment | Procedure | Treatment of acne scars on the face and/or back at needle depth settings ranging between 0.25 mm to 2.0 mm, depending on severity and location of scarring. |
| Measure | Description | Time Frame |
|---|---|---|
| Severity of Acne Scars | Goodman and Baron's Qualitative grading system. Possible scores range from 1 = mild to 4 = severe. | Baseline, 1 month post treatment, and 6 months post treatment |
| Clinician's Global Aesthetic Improvement Assessment (CGAIS) | Clinician's Global Aesthetic Improvement Assessment: minimal score is 1- Very much improved and, maximum score is 5 -Worse: The appearance is worse than the original condition | 1 month post treatment, and 6 months post treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Photo Grading of Acne Scar Assessment | Photo grading of acne scars assessment was done using the following scale [Karnik J. et al, JAAD 2014, 71 (1)]: Grade- Term- Description 0 - Clear-- No depression is seen in the treatment area. Macular discoloration may be seen.
3- Moderate-- More than half of the depressions are apparent with direct lighting (deep) 4- Severe-- All or almost all the lesions can be seen with direct lighting (deep) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas J Stephens, Ph.D | Thomas J. Stephens & Associates, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stephens & Associates | Richardson | Texas | 45081 | United States |
Only participants who met eligibility requirements were enrolled into the study and assigned to groups.
Pre-screening was conducted by phone to determine eligibility criteria through and IRB-approved script. Followed by in-clinic screening visits conducted between December 7, 2015 and February 19, 2016.
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| ID | Title | Description |
|---|---|---|
| FG000 | SkinPen II | 21 Subjects, 3 SkinPen II treatments to each patient, each one month apart. SkinPen II: Treatment of acne scars on the face and/or back at needle depth settings ranging between 0.25 mm to 2.0 mm, depending on severity and location of scarring. |
| FG001 | SkinPen Precision | 20 Subjects, 3 SkinPen precision treatments to each patient, each one month apart. SkinPen Precision: Treatment of acne scars on the face and/or back at needle depth settings ranging between 0.25 mm to 2.0 mm, depending on severity and location of scarring. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The analysis population includes all participants completing the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | SkinPen II | 3 treatments with SkinPen II to each patient, each one month apart. SkinPen: Treatment of acne scars on the face and/or back at needle depth settings ranging between 0.25 mm to 2.0 mm, depending on severity and location of scarring. |
| BG001 | SkinPen Precision |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Men and women 18-60 years of age in generally good health were enrolled after satisfying the inclusion and exclusion criteria. Their age, race, and ethnicity were recorded. |
| 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 | Severity of Acne Scars | Goodman and Baron's Qualitative grading system. Possible scores range from 1 = mild to 4 = severe. | The analysis population includes all participants who completed the study. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 1 month post treatment, and 6 months post treatment |
|
1 year, 6 months
Adverse Events (AEs) were defined as any untoward medical occurrence regardless of causal relationship with the test article.
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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 | SkinPen II | 3 SkinPen ll treatments to each patient, each one month apart. SkinPen ll: Treatment of acne scars on the face and/or back at needle depth settings ranging between 0.25 mm to 2.0 mm, depending on severity and location of scarring. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anthrapod bite | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Brown recluse - inner right thigh |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Thomas Hitchcock, PhD | Crown Laboratories, Inc. | 8883723982 | THitchcock@crownlaboratories.com |
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| Day 1 (Baseline), Day 30, Day 60, 1-Month post treatment and 6 Month post treatment |
| Subject Self-Assessment Using SASIS | Subject self-assessment was completed in 2 steps for self-assessed scar improvement scale (SASIS) and subject global aesthetic improvement scale (SGAIS):
| One Month Post Treatment, 6 Month Post Treatment |
| Subject Self-Assessment Using Global Aesthetic Improvement Scale (SGAIS) | The following rating scale was used for SGAIS: Rating and Description
| 1-Month Post Treatment and 6- Month Post Treatment |
3 treatments with SkinPen Precision to each patient, each one month apart. SkinPen: Treatment of acne scars on the face and/or back at needle depth settings ranging between 0.25 mm to 2.0 mm, depending on severity and location of scarring. |
| BG002 | Total | Total of all reporting groups |
| 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 |
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| Region of Enrollment | Participants were treated and evaluated in Dallas, Texas, USA. | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Primary | Clinician's Global Aesthetic Improvement Assessment (CGAIS) | Clinician's Global Aesthetic Improvement Assessment: minimal score is 1- Very much improved and, maximum score is 5 -Worse: The appearance is worse than the original condition | The analysis population includes all participants who completed the study. | Posted | Mean | Standard Deviation | score on a scale | 1 month post treatment, and 6 months post treatment |
|
|
|
|
| Secondary | Photo Grading of Acne Scar Assessment | Photo grading of acne scars assessment was done using the following scale [Karnik J. et al, JAAD 2014, 71 (1)]: Grade- Term- Description 0 - Clear-- No depression is seen in the treatment area. Macular discoloration may be seen.
3- Moderate-- More than half of the depressions are apparent with direct lighting (deep) 4- Severe-- All or almost all the lesions can be seen with direct lighting (deep) | The analyxed population includes all participants who completed the study. | Posted | Mean | Standard Deviation | Score on a Scale | Day 1 (Baseline), Day 30, Day 60, 1-Month post treatment and 6 Month post treatment |
|
|
|
|
| Secondary | Subject Self-Assessment Using SASIS | Subject self-assessment was completed in 2 steps for self-assessed scar improvement scale (SASIS) and subject global aesthetic improvement scale (SGAIS):
| Posted | Mean | Standard Deviation | Score on a Scale | One Month Post Treatment, 6 Month Post Treatment |
|
|
|
|
| Secondary | Subject Self-Assessment Using Global Aesthetic Improvement Scale (SGAIS) | The following rating scale was used for SGAIS: Rating and Description
| Posted | Mean | Standard Deviation | Score on a Scale | 1-Month Post Treatment and 6- Month Post Treatment |
|
|
|
|
| 0 |
| 21 |
| 0 |
| 21 |
| 1 |
| 21 |
| EG001 | SkinPen Precision | 3 SkinPen treatments to each patient, each one month apart. SkinPen Precision: Treatment of acne scars on the face and/or back at needle depth settings ranging between 0.25 mm to 2.0 mm, depending on severity and location of scarring. | 1 | 20 | 0 | 20 | 2 | 20 |
|
| Erythema (face) | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Oedema (face) | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Pruritus (face) | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Skin striae (forehead and both sides of face) | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Pregnancy | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
|
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| Day 60 |
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| 1-Month post treatment |
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| 6-Month post treatment |
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