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The purpose of this study is to evaluate the safety and effectiveness of a new laser for the removal of unsightly spider veins on the legs. The device used in this study is the Cutera Excel V laser, which is a dual wavelength 532 nm potassium titanyl phosphate (KTP) and 1064 nm neodymium-doped yttrium aluminum garnet (Nd:YAG) laser. The Excel V laser has received 510(k) clearance from the FDA, which means the FDA has approved the laser for dermatological and vascular conditions, like spider veins.
Each subject will receive 532 nm KTP laser treatment for their lower extremity spider veins in at least 2, and up to 4, separate areas. Subjects will receive 2 laser treatments spaced 12 weeks apart. Subjects will be followed for 24 weeks (12 weeks after the final laser treatment). Efficacy will be evaluated by blinded independent physician assessment of improvement in treated spider veins using digital photographs taken at baseline and the final follow-up visit by a third-party medical photography service. In addition, efficacy will be evaluated by the Investigator's mean global assessment of improvement and the subject's mean assessment of improvement. Safety will be evaluated by continuous monitoring of adverse events (AEs) and measuring pain associated with laser treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 532 nm KTP Laser Treatment | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 532 nm KTP Excel V Laser, manufactured by Cutera, Inc. | Device | The 532 nm KTP Excel V laser treatment parameters to be used in this study are as follows:
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Improvement of Lower Extremity Spider Veins Based on Blinded Photo Assessments | A panel of independent physicians will assess before and after digital photographs of each treated area. The physicians will be blinded to the treatment parameters and to the temporal order of the before and after photographs. Each independent physician will be asked to select the baseline photograph for each treated area and then rate the degree of improvement using the following scale:
| 24 weeks (12 weeks post-final laser treatment) |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Improvement of Lower Extremity Spider Veins Based on Blinded Photo Assessments | The panel of independent physicians will be asked to select the baseline photograph for each treated area and then rate the degree of improvement using the following scale:
|
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Main Line Center for Laser Surgery | Ardmore | Pennsylvania | 19003 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 532 nm KTP Laser Treatment | Each subject will receive 532 nm KTP laser treatment for their lower extremity spider veins |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 532 nm KTP Laser Treatment | Each subject will receive 532 nm KTP laser treatment for their lower extremity spider veins |
| 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 | Mean Improvement of Lower Extremity Spider Veins Based on Blinded Photo Assessments | A panel of independent physicians will assess before and after digital photographs of each treated area. The physicians will be blinded to the treatment parameters and to the temporal order of the before and after photographs. Each independent physician will be asked to select the baseline photograph for each treated area and then rate the degree of improvement using the following scale:
| per protocol | Posted | Mean | 95% Confidence Interval | points on Improvement scale | 24 weeks (12 weeks post-final laser treatment) |
|
24 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 | 532 nm KTP Laser Treatment | Each subject will receive 532 nm KTP laser treatment for their lower extremity spider veins |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Post-Inflammatory Hyperpigmentation at 24 weeks | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eric F. Bernstein, M.D., M.S.E. | Main Line Center for Laser Surgery | 610-645-5551 | dermguy@dermguy.com |
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| ID | Term |
|---|---|
| D013684 | Telangiectasis |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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|
| 12 weeks (post-1st laser treatment) |
| Percent of Subjects With "Significant" or "Very Significant" Improvement in Lower Extremity Spider Veins, as Assessed by the Treating Investigator. | The Investigator will perform the Physician's Global Assessment of the degree of improvement for each treated area of the subject's lower extremity spider veins using the following scale:
| 24 weeks (12 weeks post-final laser treatment) |
| Percent of Subjects With "Significant" to "Very Significant" Improvement of Lower Extremity Spider Veins, as Assessed by Subject. | Subjects will be asked to rate the improvement of each treated area of their lower extremity spider veins as compared to baseline using the following scale:
| 24 weeks (12 weeks post-final laser treatment) |
| Percent of Subjects Satisfied With Improvement of Treated Spider Veins. | Subjects will assess their satisfaction with the procedure and with the improvement in lower extremity spider veins at twelve weeks post final laser treatment based using the following scale:
| 24 weeks (12 weeks post-final laser treatment) |
| Mean Pain Score Associated With Laser Treatment. | Subjects will be asked to rate the average pain experienced during laser treatments using the 0-10 numeric pain rating scale (0 = no pain to 10 = worst possible pain). | Day 0 (1st laser treatment) |
| Mean Pain Score Associated With Laser Treatment | Subjects will be asked to rate the average pain experienced during laser treatments using the 0-10 numeric pain rating scale (0 = no pain to 10 = worst possible pain). | 12 weeks (2nd laser treatment) |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Fitzpatrick Skin Type | The Fitzpatrick Skin Type is a skin classification system based on color, genetics and reaction to sun exposure. Types range from the I to VI, where type I represents very fair-skinned individuals and type VI represents very dark-skinned individuals. | Number | participants |
|
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| Secondary | Mean Improvement of Lower Extremity Spider Veins Based on Blinded Photo Assessments | The panel of independent physicians will be asked to select the baseline photograph for each treated area and then rate the degree of improvement using the following scale:
| per protocol | Posted | Mean | 95% Confidence Interval | points on Improvement scale | 12 weeks (post-1st laser treatment) |
|
|
|
| Secondary | Percent of Subjects With "Significant" or "Very Significant" Improvement in Lower Extremity Spider Veins, as Assessed by the Treating Investigator. | The Investigator will perform the Physician's Global Assessment of the degree of improvement for each treated area of the subject's lower extremity spider veins using the following scale:
| per protocol | Posted | Number | percent of participants | 24 weeks (12 weeks post-final laser treatment) |
|
|
|
| Secondary | Percent of Subjects With "Significant" to "Very Significant" Improvement of Lower Extremity Spider Veins, as Assessed by Subject. | Subjects will be asked to rate the improvement of each treated area of their lower extremity spider veins as compared to baseline using the following scale:
| per protocol | Posted | Number | percent of participants | 24 weeks (12 weeks post-final laser treatment) |
|
|
|
| Secondary | Percent of Subjects Satisfied With Improvement of Treated Spider Veins. | Subjects will assess their satisfaction with the procedure and with the improvement in lower extremity spider veins at twelve weeks post final laser treatment based using the following scale:
| per protocol | Posted | Number | percent of participants | 24 weeks (12 weeks post-final laser treatment) |
|
|
|
| Secondary | Mean Pain Score Associated With Laser Treatment. | Subjects will be asked to rate the average pain experienced during laser treatments using the 0-10 numeric pain rating scale (0 = no pain to 10 = worst possible pain). | intent-to-treat | Posted | Mean | Standard Deviation | Numeric Pain Rating Score | Day 0 (1st laser treatment) |
|
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|
| Secondary | Mean Pain Score Associated With Laser Treatment | Subjects will be asked to rate the average pain experienced during laser treatments using the 0-10 numeric pain rating scale (0 = no pain to 10 = worst possible pain). | intent-to-treat | Posted | Mean | Standard Deviation | Numeric Pain Rating Score | 12 weeks (2nd laser treatment) |
|
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|
| 0 |
| 20 |
| 20 |
| 20 |
| Mild Edema Immediate Post-TX #1 | Skin and subcutaneous tissue disorders | Edema (swelling) | Systematic Assessment |
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| Mild Erythema Immediate Post-TX#1 | Skin and subcutaneous tissue disorders | Erythema (redness) | Systematic Assessment |
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| Moderate Erythema Post-TX#1 | Skin and subcutaneous tissue disorders | Erythema (redness) | Systematic Assessment |
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| Mild Edema Immediate Post-TX#2 | Skin and subcutaneous tissue disorders | Edema (swelling) | Systematic Assessment |
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| Moderate Edema Immediate Post-TX#2 | Skin and subcutaneous tissue disorders | Edema (swelling) | Systematic Assessment |
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| Mild Erythema Post-TX#2 | Skin and subcutaneous tissue disorders | Erythema (redness) | Systematic Assessment |
|
| Moderate Erythema Post-TX#2 | Skin and subcutaneous tissue disorders | Erythema (redness) | Systematic Assessment |
|
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