Vbeam Pro Pulse Dye Laser for the Treatment of Vascular Conditions

A Prospective Clinical Study Evaluating Pulse Dye Laser on Clearance of Vascular Indications

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.

Inclusion Criteria:

1. Healthy subjects aged 18 years or older
2. Presence of one or more vascular lesion, cutaneous lesion, or other dermatological condition deemed fit for treatment
3. Able and willing to comply with the treatment/follow-up schedule and comply with all study (protocol) requirements.
4. Willing to provide signed, informed consent to participate in the study
5. Willing to have photographs and images taken of the treated areas to be used in evaluations, publications, presentations, and marketing materials

Exclusion Criteria:

1. Pregnant or planning to become pregnant, having given birth less than 3 months prior to enrollment into the study, and/or breast feeding
2. Known photosensitivity to 595nm or 1064 nm light
3. History of light-induced seizure disorders
4. Severe unstable concurrent conditions, such as unstable cardiac disorders
5. Use of implanted medical device including pacemakers, cardioverters and other implantable devices or fillers per investigator discretion (consultation with physicians prior to treatment is required)
6. Use of photosensitizing medications (medications that introduce photosensitivity or medications within or above the 595 nm wavelength, refer to Candela's list of drugs that may cause photosensitivity)
7. Tattoos (including decorative, permanent makeup and radiation port tattoos) in the intended study treatment area (595nm use only)
8. Active Herpes Simplex Virus (HSV) in the intended treatment area unless treated with prophylactic medication
9. The intended treatment area has significant sun exposure within the past 2 weeks or self-tanner has been applied to the treatment area
10. In the opinion of the Investigator, the subject is unwilling or unable to adhere to the study requirements or is otherwise unsuitable for the study