An interventional study of Vbeam Pro Laser Treatment in Rosacea, Vascular Diseases and Port-Wine Stain, sponsored by Candela Corporation. Enrolling by invitation at 1 site in Spain. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-02.
Sponsored by Candela Corporation · Not applicable, Interventional, and Treatment
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
Phase II: Safety, Efficacy, and Optimization of Treatment Parameters
Additional follow up visits may be added, if necessary, per Sponsor and investigators' discretion.
233 studies on the registry are indexed under Rosacea; 23 are open to participants now.
This study's planned enrollment of 40 is below the median of 61 across 200 interventional studies indexed under Rosacea.
Browse Rosacea studies →Candela Corporation is the lead sponsor of 19 studies on the registry; 1 is open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 5 (71%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Treatment with Vbeam Pro Laser System, up to eight (8) study treatments
Device: Vbeam Pro Laser Treatment
Treatment with Vbeam Pro Laser System
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. IGA Scale range -1 (worse, \<0% improvement) to 5 (complete resolution, 100% improvement).
Time frame: Baseline to Follow-up #1 (up to 72 weeks)
Investigator Global Aesthetic Improvement Scale
Evaluation of investigator rated scales following the treatment series Evaluation of investigator global aesthetic improvement scale (IGAIS) following the treatment series for treatment areas or comparing split treatment areas. IGAIS scale ranges from -1 (worse) to 3 (very much improved).
Time frame: 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. Subject Satisfaction Scale ranges from -2 (very dissatisfied) to 2 (very satisfied).
Time frame: Baseline to Follow-up #1 (up to 72 weeks)
Plan to share: No
No publications or documents are linked to this record.
Started Dec 2025 (actual). Primary completion is estimated for Dec 2028, 36 months after the start.
Of 42 interventional studies with no phase under Rosacea, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 29. This study's planned 36 months is above that.
Start moved once since we started tracking on Sep 25, 2026: Mar 2026 → Dec 2025, on Nov 2, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
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