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A single-center prospective, open-label uncontrolled pilot study. Subjects will receive laser treatments and will be followed at 12 weeks post-final treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment with Microlens Array | Experimental | Treatment with Cutera Microlens Array Device used with the enlighten™ 532nm /1064nm/670nm laser |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Microlens Array | Device | Treatment with Cutera Microlens Array Device used with the enlighten™ 532nm /1064nm/670nm laser |
|
| Measure | Description | Time Frame |
|---|---|---|
| Physician's Global Assessment of Improvement | Degree of improvement at 12 weeks post-final treatment as assessed by the Investigator. Higher scores indicate better outcomes 3= Very significant Improvement 2= Significant Improvement 1= Moderate Improvement 0= Mild or No Improvement | 12 weeks post final treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephen Ronan, MD | P.I. | 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 | Treatment With Microlens Array | Treatment with Cutera Microlens Array Device used with the enlighten™ 532nm /1064nm/670nm laser |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment With Microlens Array | Treatment with Cutera Microlens Array Device used with the enlighten™ 532nm /1064nm/670nm laser |
| 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 | Physician's Global Assessment of Improvement | Degree of improvement at 12 weeks post-final treatment as assessed by the Investigator. Higher scores indicate better outcomes 3= Very significant Improvement 2= Significant Improvement 1= Moderate Improvement 0= Mild or No Improvement | Posted | Mean | Standard Deviation | score on a scale | 12 weeks post final treatment |
|
|
12 weeks post final treatment
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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 | Treatment With Microlens Array | Treatment with Cutera Microlens Array Device used with the enlighten™ 532nm /1064nm/670nm laser |
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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 |
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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 | Jun 16, 2016 | Jul 24, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D002921 | Cicatrix |
| ID | Term |
|---|---|
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
| 0 |
| 7 |
| 0 |
| 7 |
| 7 |
| 7 |
| Edema | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Petechiae | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
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