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The purpose of this study to evaluate the SmartLipo Triplex laser system along with the SideLaze800 hand piece in the treatment of Acne Scars.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SmartLipo Triplex laser system along with the SideLaze800 hand | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SmartLipo Triplex laser system along with the SideLaze800 hand piece | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Facial Acne Improvement Using the Global Aesthetic Improvement Scale | This assesses the level of improvement of acne scarring using the Global Aesthetic Improvement Scale. It is done through using photographic evaluation, comparing the baseline photograph to a photograph taken 3 months post the last treatment. The options for the acne scarring improvement are very much improved, much improved, improved, no change, or worse. The photographic evaluator decides this improvement based off of scar appearance differences amongst the photographs. | 3 months post treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Investigator Satisfaction Questionnaire | The investigator chooses if they are extremely satisfied, satisfied, slightly satisfied, slightly dissatisfied, dissatisfied, or extremely dissatisfied with the results. | 3 months post treatment |
| Subject Satisfaction Questionnaire |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Patricia Krantz | Cynosure, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New Jersey Plastic Surgery | Montclair | New Jersey | 07042 | United States |
One additional patient was enrolled beyond the limitations specified by the original protocol. The protocol was amended (and approved by the IRB) part way through the study to allow for the enrollment of this additional subject.
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| ID | Title | Description |
|---|---|---|
| FG000 | SmartLipo Triplex Laser System Along With the SideLaze800 Hand | SmartLipo Triplex laser system along with the SideLaze800 hand piece |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | SmartLipo Triplex Laser System Along With the SideLaze800 Hand | SmartLipo Triplex laser system along with the SideLaze800 hand piece |
| 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 | Percentage of Participants With Facial Acne Improvement Using the Global Aesthetic Improvement Scale | This assesses the level of improvement of acne scarring using the Global Aesthetic Improvement Scale. It is done through using photographic evaluation, comparing the baseline photograph to a photograph taken 3 months post the last treatment. The options for the acne scarring improvement are very much improved, much improved, improved, no change, or worse. The photographic evaluator decides this improvement based off of scar appearance differences amongst the photographs. | 1 subject completed the follow up over the phone, so there is no physician score for this subject. 2 subjects were a no-show for their appointment, but attended the other optional follow ups. The other 4 did not return to follow ups and could not be reached after numerous attempts to follow up. | Posted | Number | percentage of participants | 3 months post treatment |
|
Adverse Events occurring were captured and followed for the study duration, about 5 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 | SmartLipo Triplex Laser System Along With the SideLaze800 Hand | SmartLipo Triplex laser system along with the SideLaze800 hand piece |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain | Nervous system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jamie Trimper | Cynosure | 800-886-2966 | jamie.trimper@cynosure.com |
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The subject chooses if they are extremely satisfied, satisfied, slightly satisfied, slightly dissatisfied, dissatisfied, or extremely dissatisfied with the results. |
| 3 months post treatment |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Fitzpatrick Skin Type | The Fitzpatrick Skin Score is used to determine skin color. It is a numerical system that classifies skin into six types (Type I, Type II, Type III, Type IV, Type V and Type VI) based on the numerical score achieved (ranging from 0 to 36). The lower the score (and skin type number), the fairer the skin. The higher the score (and skin type number), the more deeply pigmented the skin is. The scale comes from this source: Gupta, Sharma. Skin typing: Fitzpatrick grading and others. Clinics in Dermatology. 2019;37(5):430-436. doi:10.1016/j.clindermatol.2019.07.010 | Count of Participants | Participants |
|
SmartLipo Triplex laser system along with the SideLaze800 hand piece |
|
|
| Secondary | Investigator Satisfaction Questionnaire | The investigator chooses if they are extremely satisfied, satisfied, slightly satisfied, slightly dissatisfied, dissatisfied, or extremely dissatisfied with the results. | 1 subject completed the follow up over the phone, so there is no physician score for this subject. 2 subjects were a no-show for their appointment, but attended the other optional follow ups. The other 4 did not return to follow ups and could not be reached after numerous attempts to follow up. | Posted | Count of Participants | Participants | 3 months post treatment |
|
|
|
| Secondary | Subject Satisfaction Questionnaire | The subject chooses if they are extremely satisfied, satisfied, slightly satisfied, slightly dissatisfied, dissatisfied, or extremely dissatisfied with the results. | 2 subjects were a no-show for their appointment, but attended the other optional follow ups. The other 4 did not return to follow ups and could not be reached after numerous attempts to follow up. | Posted | Count of Participants | Participants | 3 months post treatment |
|
|
|
| 0 |
| 21 |
| 0 |
| 21 |
| 16 |
| 21 |
| Swelling | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Bruising | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Numbness | Nervous system disorders | Systematic Assessment |
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| Headache | Nervous system disorders | Systematic Assessment |
|
The PI cannot disclose confidential or proprietary information until after it becomes generally known or available to the public.
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
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| slightly dissatisfied |
|