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This is a multi-center, multi-cohort, prospective, open-label study of VELOS for treatment of vascular skin disorders. The plan is to enroll up to 60 subjects from up to 3 centers in the US and worldwide. The purpose is to collect data from the use of VELOS.
The primary objective of this trial is to collect data from the use of VELOS in clinical practice under a wide range of treatment parameters variability including RF energy, laser fluence, and laser pulse duration for treating each of the vascular disorders. This will be conducted by documenting the physician selected treatment parameters, as well as the subjects' clinical clearing response, perception of improvement and sensations, through the study treatments and post-treatment(s) follow-up visits.
Optional exploratory objectives: Collection of safety and efficacy data of the Velos with DCD cooling and Velos with contact cooling. The investigator may opt to include in this study noninvasive measurements of erythema, melanin and texture (which may be performed by eg. Chromameter, Mexameter or 3D imaging), and measurements of linear vessel diameters and lesion size.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 -facial skin disorders | Experimental | Pulsed dye laser/bipolar radiofrequency (Velos) treatment of facial skin disorders including photo-damage, age spots, lentigos, solar telangiectasia and general facial telangiectasia |
|
| Cohort 2 - leg veins | Experimental | Pulsed dye laser/bipolar radiofrequency (Velos) treatment of leg veins of diameter of at least 1mm, i.e., venulectasia and reticular leg veins. |
|
| Cohort 3-general skin rejuvenation | Experimental | Pulsed dye laser/bipolar radiofrequency (Velos) treatment treatment of general skin rejuvenation including Rosacea, erythematous scars (including acne), and erythematous striae (subjects enrolled in this group must have at least two of the above mentioned treatment indications. |
|
| Cohort 4-improving skin laxity | Experimental | Velos (Bipolar radiofrequency only) treatment for improving skin laxity or skin tightness/firmness |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| velos | Device | VELOS combines 595nm pulsed dye laser energy with bipolar RF energy. The study device can deliver 0.45 to 40 ms laser pulses at a maximum of 25 J/cm2 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evidence of leg vein and skin improvement by validated vascular assessment scale and wrinkle assessment scale | Evidence of leg vein and skin improvement by validated vascular assessment scale and wrinkle assessment scale | up to 3 months after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Number and severity of all complications caused by the laser will be recorded and descriptively tabulated | up to 3 months | |
| Subject Improvement Questionnaire | up to 6 months | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shlomit Mann, MSc | Contact | +972732442347 | shlomitm@syneron-candela.com |
| Name | Affiliation | Role |
|---|---|---|
| Shlomit Mann, MSc | Syneron Medical | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Scripps Clinic - Carmel Valley | Active, not recruiting | San Diego | California | 92130 | United States | |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15004818 | Background | Sadick NS, Makino Y. Selective electro-thermolysis in aesthetic medicine: a review. Lasers Surg Med. 2004;34(2):91-7. doi: 10.1002/lsm.20013. | |
| 16176773 | Background | Sadick NS. Combination radiofrequency and light energies: electro-optical synergy technology in esthetic medicine. Dermatol Surg. 2005 Sep;31(9 Pt 2):1211-7; discussion 1217. doi: 10.1111/j.1524-4725.2005.31928. |
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| Subject assessment of comfort level associated with treatment |
Numerical Response Scale for Rating Pain (NRS) |
| day 0, afer 4 weeks, 8 weeks and 12 weeks |
| Syneron Candela Institute for Education Clinic |
| Recruiting |
| Wayland |
| Massachusetts |
| 01778 |
| United States |
|
| Zel Skin & Laser Specialists | Completed | Edina | Minnesota | 55424 | United States |
| Laser and Skin Surgery Center of New York | Completed | New York | New York | 10016 | United States |