Vbeam Pro Pulse Dye Laser for the Treatment of Vascular Conditions
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCandela Corporation
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Vbeam Pro Laser Treatment
DeviceTreatment with Vbeam Pro Laser System
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: Vbeam Pro Treatment GroupExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
Baseline to Follow-up #1 (up to 72 weeks)Secondary outcomes
1
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
Time frame
Baseline to Follow-up #1 (up to 72 weeks)2
Subject Satisfaction Scale
Evaluation of subject satisfaction following the treatment series for treatment areas or comparing split treatment areas.
Time frame
Baseline to Follow-up #1 (up to 72 weeks)Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: