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To evaluate the safety and efficacy of the Cutera laser system for the treatment of acne vulgaris.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Laser Treatment | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cutera Laser System | Device | Subjects will receive laser treatments |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving Treatment Success | Primary effectiveness objective was to show more than 50% of subjects enrolled were Responders who achieved Treatment Success, where Treatment Success was defined as a subject with ≥50% fewer inflammatory acne lesions with respect to baseline | 12 weeks post final treatment, up to 24 weeks |
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Inclusion Criteria:
Exclusion Criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cutera Research Center | Brisbane | California | 94005 | United States | ||
| Blackhawk Plastic Surgery |
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| ID | Title | Description |
|---|---|---|
| FG000 | Laser Treatment | Cutera Laser System: Subjects will receive laser treatments |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Laser Treatment | Cutera Laser System: Subjects will receive laser treatments |
| 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 | Percentage of Participants Achieving Treatment Success | Primary effectiveness objective was to show more than 50% of subjects enrolled were Responders who achieved Treatment Success, where Treatment Success was defined as a subject with ≥50% fewer inflammatory acne lesions with respect to baseline | Posted | Count of Participants | Participants | No | 12 weeks post final treatment, up to 24 weeks |
|
|
1 year post final treatment, up to approximately 18 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 | Laser Treatment | Cutera Laser System: Subjects will receive laser treatments | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Erythema | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director Clinical Research | Cutera | 415-657-5518 | mdoucette@cutera.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 | Apr 16, 2021 | Sep 29, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000152 | Acne Vulgaris |
| ID | Term |
|---|---|
| D017486 | Acneiform Eruptions |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012625 | Sebaceous Gland Diseases |
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Outcome Assessor is blinded to study design and time point being assessed.
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| Danville |
| California |
| 94506 |
| United States |
| Center for Dermatology Clinical Research, Inc | Fremont | California | 94538 | United States |
| Laser and Skin Surgery Center of Northern CA | Sacramento | California | 95816 | United States |
| Kwan Dermatology | San Francisco | California | 94108 | United States |
| Skin Research Institute | Coral Gables | Florida | 33146 | United States |
| Skin Laser & Surgery Specialists, a Division of Schweiger Dermatology | Hackensack | New Jersey | 07601 | United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
|
|
| 104 |
| 0 |
| 104 |
| 104 |
| 104 |
| Edema | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Acne Purging | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Dryness | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
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