Vbeam Pro Pulse Dye Laser for the Treatment of Vascular Conditions

NCT07290426 | Not Yet Recruiting FDA Device

• 1 other identifier: VBP25005
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Rosacea; Vascular Diseases; Port-Wine Stain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Investigator Global Aesthetic Improvement Scale

  Baseline to Follow-up #1 (up to 72 weeks)

• Subject Satisfaction Scale

  Baseline to Follow-up #1 (up to 72 weeks)

Study Arms (1)

Vbeam Pro Treatment Group

EXPERIMENTAL

Treatment with Vbeam Pro Laser System, up to eight (8) study treatments

Device: Vbeam Pro Laser Treatment

Interventions

Vbeam Pro Laser Treatment DEVICE

Treatment with Vbeam Pro Laser System

Vbeam Pro Treatment Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Pregnant or planning to become pregnant, having given birth less than 3 months prior to enrollment into the study, and/or breast feeding
• Known photosensitivity to 595nm or 1064 nm light
• History of light-induced seizure disorders
• Severe unstable concurrent conditions, such as unstable cardiac disorders
• 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)
• 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)
• Tattoos (including decorative, permanent makeup and radiation port tattoos) in the intended study treatment area (595nm use only)
• Active Herpes Simplex Virus (HSV) in the intended treatment area unless treated with prophylactic medication
• The intended treatment area has significant sun exposure within the past 2 weeks or self-tanner has been applied to the treatment area
• 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

Sponsors & Collaborators

• Candela Corporation: lead

MeSH Terms

Conditions

Rosacea; Vascular Diseases; Port-Wine Stain

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Cardiovascular Diseases; Skin Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Maya Duffy

CONTACT

(508) 358-7400; mayajade.duffy@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Treatment Group with Vbeam Pro Pulse Dye Laser

Study Record Dates

• First Submitted: December 16, 2025
• First Posted: December 18, 2025
• Study Start: March 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share