Not Yet RecruitingNot Applicable

Vbeam Pro Pulse Dye Laser for the Treatment of Vascular Conditions

40 participantsStarted 2026-03

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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

Exclusion criteria

✕. 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

What they're measuring

Clearance of Vascular Lesion

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

Trial details

NCT IDNCT07290426

SponsorCandela Corporation

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2028-12

Contact for this trial

Maya Duffy

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

View on ClinicalTrials.gov More Rosacea trials