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The purpose of this pivotal investigation is to evaluate the efficacy and safety of the Cutera enlighten multi-wavelength 532 nm and 1064 nm picosecond pulse duration laser and an investigational micro-lens array (MLA) handpiece attachment for improvement of moderate to severe acne scars.
This is an open-label, prospective, multicenter, pivotal study in approximately 15 male or female subjects, age 18 to 65 years who desire laser treatment for the improvement of moderate to severe acne scars. Subjects will receive laser treatments with the Cutera enlighten laser with the Micro-Lens Array handpiece attachment. Subjects will return to the site after all study treatments have been delivered for a follow-up visit at 12 weeks following their final study treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enlighten™ Laser and a MLA Attachment | Other | Enlighten™ Laser and a Micro-Lens Array Handpiece Attachment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enlighten™ Laser and a MLA Attachment | Device | Subjects will receive treatments with the Cutera enlighten laser with the Micro-Lens Array handpiece attachment. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Acne Scarring Improvement | An improvement in Acne Scarring of at least one point on the Acne Scar Assessment Scale (ASAS):(1=clear scarring, 2=Very Mild scarring, 3=Mild scarring, 4=Moderate scarring or 5=Severe scarring) at the 12 weeks post final treatment | Baseline, and at 12 weeks post final treatment (up to 30 weeks) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephen Ronan, M.D. | Cutera Research Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cutera Research Center | Brisbane | California | 94005 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Enlighten™ Laser and a MLA Attachment | Subjects will receive treatments with the Cutera enlighten laser with the Micro-Lens Array handpiece attachment |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Enlighten™ Laser and a MLA Attachment | Subjects will receive treatments with the Cutera enlighten laser with the Micro-Lens Array handpiece attachment |
| 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 Scarring Improvement | An improvement in Acne Scarring of at least one point on the Acne Scar Assessment Scale (ASAS):(1=clear scarring, 2=Very Mild scarring, 3=Mild scarring, 4=Moderate scarring or 5=Severe scarring) at the 12 weeks post final treatment | Posted | Mean | Standard Deviation | score on a scale | Baseline, and at 12 weeks post final treatment (up to 30 weeks) |
|
|
12 weeks post-final treatment, up to 8 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 | Enlighten™ Laser and a MLA Attachment | Subjects will receive treatments with the Cutera enlighten laser with the Micro-Lens Array handpiece attachment |
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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 | |
|---|---|---|---|---|
| Margot Doucette | Cutera | 415-656-9612 | mdoucette@cutera.com |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 3, 2018 | Sep 1, 2023 | Prot_001.pdf |
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| ID | Term |
|---|---|
| D002921 | Cicatrix |
| D000152 | Acne Vulgaris |
| ID | Term |
|---|---|
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D017486 | Acneiform Eruptions |
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| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
|
| 0 |
| 4 |
| 0 |
| 4 |
| 4 |
| 4 |
| Edema | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Discomfort | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
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| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012625 | Sebaceous Gland Diseases |