Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
Phase II: Safety, Efficacy, and Optimization of Treatment Parameters
Additional follow up visits may be added, if necessary, per Sponsor and investigators' discretion.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vbeam Pro Treatment Group | Experimental | Treatment with Vbeam Pro Laser System, up to eight (8) study treatments |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vbeam Pro Laser Treatment | Device | Treatment with Vbeam Pro Laser System |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to Follow-up #1 (up to 72 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline to Follow-up #1 (up to 72 weeks) |
| Subject Satisfaction Scale |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maya Duffy | Contact | (508) 358-7400 | mayajade.duffy@gmail.com |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D012393 | Rosacea |
| D014652 | Vascular Diseases |
| D019339 | Port-Wine Stain |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D002318 | Cardiovascular Diseases |
| D012868 | Skin Abnormalities |
Not provided
Not provided
Treatment Group with Vbeam Pro Pulse Dye Laser
Not provided
Not provided
Not provided
Not provided
Evaluation of subject satisfaction following the treatment series for treatment areas or comparing split treatment areas. |
| Baseline to Follow-up #1 (up to 72 weeks) |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |