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The purpose of this study is to assess treatment of facial acne scars using the 755nm Alexandrite Laser with lens arrays.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 755nm Alexandrite laser with lens array | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 755nm Alexandrite laser with lens array | Device |
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| Measure | Description | Time Frame |
|---|---|---|
| Severity Change in Acne Scarring | The scale is a Physician Global Scarring Grading Scale, which counts and types scars by tallying up of the number and severity according to an organized grading system, where 0 is the lowest point value and represents no scarring. The theoretical highest score possible is an 84. The change in the score from the baseline to the follow up was collected. A negative change indicates a decrease in points (which indicates improvement). | Baseline and 1 month post treatment |
| Severity Change in Acne Scarring | The scale is a Physician Global Scarring Grading Scale, which counts and types scars by tallying up of the number and severity according to an organized grading system, where 0 is the lowest point value and represents no scarring. The theoretical highest score possible is an 84. The change in the score from the baseline to the follow up was collected. A negative change indicates a decrease in points (which indicates improvement). | Baseline and 3 months post treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Investigator Satisfaction Questionnaire | Investigator will complete satisfaction questionnaire at follow up visits from 0 to 3, where 0 is extremely dissatisfied and 3 is extremely satisfied. | 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 |
|---|---|---|---|---|---|---|
| Laser & Skin Surgery Center of Northern California | Sacramento | California | 95816 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 755nm Alexandrite Laser With Lens Array | 755nm Alexandrite laser with lens array |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 755nm Alexandrite Laser With Lens Array | 755nm Alexandrite laser with lens array |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Severity Change in Acne Scarring | The scale is a Physician Global Scarring Grading Scale, which counts and types scars by tallying up of the number and severity according to an organized grading system, where 0 is the lowest point value and represents no scarring. The theoretical highest score possible is an 84. The change in the score from the baseline to the follow up was collected. A negative change indicates a decrease in points (which indicates improvement). | 1 subject was pregnant, 1 subject was lost to follow up, and 1 subject withdrew consent. 3 subjects missed their visits. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 1 month post treatment |
|
Adverse Events occurring will be captured and followed throughout each subject's participation in the study, approximately 10 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 | 755nm Alexandrite Laser With Lens Array | 755nm Alexandrite laser with lens array |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Redness | Skin and subcutaneous tissue 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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| ID | Term |
|---|---|
| D053844 | Lasers, Solid-State |
| ID | Term |
|---|---|
| D007834 | Lasers |
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
| D055618 | Radiation Equipment and Supplies |
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Subject will complete satisfaction questionnaire at follow up visits from 0 to 3, where 0 is extremely dissatisfied and 3 is extremely satisfied. |
| 3 months post treatment |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
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| 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 |
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| Units | Counts |
|---|---|
| Participants |
|
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| Secondary | Investigator Satisfaction Questionnaire | Investigator will complete satisfaction questionnaire at follow up visits from 0 to 3, where 0 is extremely dissatisfied and 3 is extremely satisfied. | 1 subject was pregnant, 1 subject was lost to follow up, and 1 subject withdrew consent. | Posted | Number | participants | 3 months post treatment |
|
|
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| Secondary | Subject Satisfaction Questionnaire | Subject will complete satisfaction questionnaire at follow up visits from 0 to 3, where 0 is extremely dissatisfied and 3 is extremely satisfied. | 1 subject was pregnant, 1 subject was lost to follow up, and 1 subject withdrew consent. | Posted | Number | participants | 3 months post treatment |
|
|
|
| Primary | Severity Change in Acne Scarring | The scale is a Physician Global Scarring Grading Scale, which counts and types scars by tallying up of the number and severity according to an organized grading system, where 0 is the lowest point value and represents no scarring. The theoretical highest score possible is an 84. The change in the score from the baseline to the follow up was collected. A negative change indicates a decrease in points (which indicates improvement). | 1 subject was pregnant, 1 subject was lost to follow up, and 1 subject withdrew consent. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 3 months post treatment |
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|
| 0 |
| 20 |
| 0 |
| 20 |
| 17 |
| 20 |
| Edema | Skin and subcutaneous tissue disorders | Systematic Assessment |
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The PI cannot disclose confidential or proprietary information until after it becomes generally known or available to the public.
| Title |
|---|
| Measurements |
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| Extremely Dissatisfied |
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| Measurements |
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| Extremely Dissatisfied |
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