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 Overview

• Status: Not yet recruiting
• Conditions: Vascular Diseases; Rosacea; Port-Wine Stain
• Intervention / Treatment: Device: Vbeam Pro Laser Treatment

Detailed Description

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
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maya Duffy; Phone Number: (508) 358-7400; Email: mayajade.duffy@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vbeam Pro Treatment Group; Treatment with Vbeam Pro Laser System, up to eight (8) study treatments	Device: Vbeam Pro Laser Treatment; Treatment with Vbeam Pro Laser System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Secondary Outcome Measures

Outcome Measure	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	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)

Collaborators and Investigators

• Sponsor: Candela Corporation

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: December 16, 2025
• First Submitted That Met QC Criteria: December 16, 2025
• First Posted (Actual): December 18, 2025

Study Record Updates

• Last Update Posted (Actual): December 18, 2025
• Last Update Submitted That Met QC Criteria: December 16, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Skin Diseases; Congenital Abnormalities; Skin Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin and Connective Tissue Diseases; Vascular Diseases; Port-Wine Stain; Rosacea
• Other Study ID Numbers: VBP25005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No