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A single center prospective, randomized, controlled split face study comparing a 532nm KTP laser with a 595nm PDL for the treatment of Erythematotelangiectatic Rosacea and Papulopustular Rosacea.
Subjects will receive laser treatments and will be followed at 6 weeks post-final laser treatment.
The purpose of this study is to evaluate the safety and efficacy of the 532nm KTP laser within the Cutera® Excel V system for the treatment of Erythematotelangiectatic Rosacea and Papulopustular Rosacea as compared to a 595nm Pulse Dye Laser.
The objectives of this study are:
1) To evaluate and compare the safety and efficacy of the laser treatments for Erythematotelangiectatic Rosacea and Papulopustular Rosacea at 6 weeks post final laser treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 532nm KTP Laser vs 595nm Pulse Dye Laser | Experimental | This is a single-center prospective, randomized, controlled split-face study in 20 subjects diagnosed with Erythematotelangiectatic Rosacea and/or Papulopustular Rosacea. This two arm, split-face study will consist of:
Each subject's face will be divided in half and labeled as A (Right Side of the Face) or B (Left Side of Face). The allocation of treatment (532nm KTP laser) and active control treatment (595nm PDL) arms will be determined by randomization. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 532nm KTP Laser vs 595nm Pulse Dye Laser | Device | Intervention for the Cutera Excel V system is to cease treatment to any subject that is experiencing any adverse reaction. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Degree of Improvement in Erythematotelangiectatic Rosacea and Papulopustular Rosacea | Measured for each treatment arm based on blinded physician assessment of subject photographs using the Physician's Global Assessment Scale (min=0; max=4) Higher scores mean better improvement 0 = 0% Improvement (None)
| 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephen Ronan, MD | Study Principal Investigator | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Miami Dermatology & Laser Institute | Miami | Florida | 33173 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | All Study Participants | Subjects will be treated with the Excel V 532nm (KTP) Laser and the 595nm Pulse Dye Laser: One half of the face will be treated with the 532nm KTP laser and the other half of the face will be treated with the 595nm Pulse Dye Laser. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Enrolled Subjects | Cutera® Excel V Excel V 532nm (KTP) Laser or 595nm Pulse Dye Laser: Each subject's face will be divided in half and labeled as A (Right Side of the Face) or B (Left Side of Face). The allocation of treatment (532nm KTP laser) and active control treatment (595nm PDL) arms will be determined by randomization. |
| 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 | Degree of Improvement in Erythematotelangiectatic Rosacea and Papulopustular Rosacea | Measured for each treatment arm based on blinded physician assessment of subject photographs using the Physician's Global Assessment Scale (min=0; max=4) Higher scores mean better improvement 0 = 0% Improvement (None)
| Posted | Mean | Standard Deviation | score on a scale | 6 weeks |
|
6 weeks
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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 | 532nm KTP Laser | Cutera® Excel V Excel V 532nm (KTP) Laser or 595nm Pulse Dye Laser: Each subject's face will be divided in half and labeled as A (Right Side of the Face) or B (Left Side of Face). The allocation of treatment (532nm KTP laser) and active control treatment (595nm PDL) arms will be determined by randomization. |
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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 | 415-657-5518 | mdoucette@cutera.com |
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| ID | Term |
|---|---|
| D012393 | Rosacea |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| 0 |
| 22 |
| 0 |
| 22 |
| 22 |
| 22 |
| EG001 | 595nm Pulse Dye Laser | 595nm Pulse Dye Laser Excel V 532nm (KTP) Laser or 595nm Pulse Dye Laser: Each subject's face will be divided in half and labeled as A (Right Side of the Face) or B (Left Side of Face). The allocation of treatment (532nm KTP laser) and active control treatment (595nm PDL) arms will be determined by randomization. | 0 | 22 | 0 | 22 | 22 | 22 |
| Edema | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
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