This is a clinical study to evaluate the safety and performance of the Vbeam Pro Laser System for the treatment of vascular indications, including rosacea and port wine stain birthmarks.
Study Design This is a non-randomized, open-label clinical study evaluating clinical treatments with the Vbeam Pro system for the treatment of vascular indications, including rosacea and port wine stain birthmarks. There are two phases of this study: Phase I: Safety 1. Screening and Enrollment Visit 2. Up to Three (3) Treatment Visits (with treatment intervals from 2 weeks to 6 weeks). 3. 7 Day (+/- 5 days) Follow Up Visit following Each Treatment Session (may be a virtual telephone or video visit) 4. Additional follow-up visits may be required per the discretion of the principal investigator to assess safety and healing progression Phase II: Safety, Efficacy, and Optimization of Treatment Parameters 1. Screening and Enrollment Visit 2. Treatment visits are limited to up to eight (8) study treatments (with treatment intervals from 1 week to 8 weeks). 3. Follow-up #1 (4 weeks - 8 weeks) 4. Follow-up #2 (8 weeks - 16 weeks) (optional) Additional follow up visits may be added, if necessary, per Sponsor and investigators' discretion.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Treatment with Vbeam Pro Laser System
Clearance of Vascular Lesion
Evaluation of clearance of vascular indications following treatment series as indicated by a minimum 1-point improvement on the validated Investigator's Global Assessment (IGA) Scale at study endpoint relative to baseline as rated by the principal investigator.
Time frame: Baseline to Follow-up #1 (up to 72 weeks)
Investigator Global Aesthetic Improvement Scale
Evaluation of investigator rated scales following the treatment series Evaluation of investigator GAIS following the treatment series for treatment areas or comparing split treatment areas
Time frame: Baseline to Follow-up #1 (up to 72 weeks)
Subject Satisfaction Scale
Evaluation of subject satisfaction following the treatment series for treatment areas or comparing split treatment areas.
Time frame: Baseline to Follow-up #1 (up to 72 weeks)
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