RosaceaNCT07290426
Vbeam Pro Pulse Dye Laser for the Treatment of Vascular Conditions
A study testing Vbeam Pro Laser Treatment in people with Rosacea and Vascular Diseases, run by Candela Corporation.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Rosacea, Vascular Diseases, Port-Wine Stain
- What is being tested?
- Vbeam Pro Laser Treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Mar 2026to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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
- Screening and Enrollment Visit
- Up to Three (3) Treatment Visits (with treatment intervals from 2 weeks to 6 weeks).
- 7 Day (+/- 5 days) Follow Up Visit following Each Treatment Session (may be a virtual telephone or video visit)
- 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
- Screening and Enrollment Visit
- Treatment visits are limited to up to eight (8) study treatments (with treatment intervals from 1 week to 8 weeks).
- Follow-up #1 (4 weeks - 8 weeks)
- Follow-up #2 (8 weeks - 16 weeks) (optional)
Additional follow up visits may be added, if necessary, per Sponsor and investigators' discretion.
- Conditions
- Rosacea, Vascular Diseases, Port-Wine Stain
- Being tested
- Vbeam Pro Laser Treatment
- Medical subject headings
- Rosacea, Vascular Diseases, Port-Wine Stain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vbeam Pro Laser TreatmentDevice
Treatment with Vbeam Pro Laser System
| Study group | Role | What they receive |
|---|---|---|
| Vbeam Pro Treatment Group | Experimental | Treatment with Vbeam Pro Laser System, up to eight (8) study treatments Receives: Device: Vbeam Pro Laser Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to Follow-up #1 (up to 72 weeks)
Secondary outcomes (2)
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
Measured: 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.
Measured: Baseline to Follow-up #1 (up to 72 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2025
- Study startMar 2026 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RosaceaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Treatment Group with Vbeam Pro Pulse Dye Laser
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Candela Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07290426
- Sponsor's protocol ID
- VBP25005
- Status last verified
- Dec 2025
- First submitted
- 16 Dec 2025
- Last updated
- 18 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Clinical Study Evaluating Pulse Dye Laser on Clearance of Vascular Indications
- ClinicalTrials.gov ID
- NCT07290426
- Acronym / sponsor ID
- VBP25005
- Conditions
- Rosacea, Vascular Diseases, Port-Wine Stain
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Candela CorporationIndustry (pharma, biotech, devices)
- Study start
- Mar 2026 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 18 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Screening and Enrollment Visit
- Up to Three (3) Treatment Visits (with treatment intervals from 2 weeks to 6 weeks).
- 7 Day (+/- 5 days) Follow Up Visit following Each Treatment Session (may be a virtual telephone or video visit)
- 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
- Screening and Enrollment Visit
- Treatment visits are limited to up to eight (8) study treatments (with treatment intervals from 1 week to 8 weeks).
- Follow-up #1 (4 weeks - 8 weeks)
- Follow-up #2 (8 weeks - 16 weeks) (optional)
Additional follow up visits may be added, if necessary, per Sponsor and investigators' discretion.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Treatment Group with Vbeam Pro Pulse Dye Laser
| Arm | Type | Receives |
|---|---|---|
| Vbeam Pro Treatment Group | Experimental | Device: Vbeam Pro Laser TreatmentTreatment with Vbeam Pro Laser System, up to eight (8) study treatments |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vbeam Pro Laser TreatmentTreatment with Vbeam Pro Laser System | Device | Vbeam Pro Treatment Group |
Primary outcome
Clearance of Vascular Lesion
Time frame: Baseline to Follow-up #1 (up to 72 weeks)
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.
2 secondary outcomes
Investigator Global Aesthetic Improvement Scale
Time frame: Baseline to Follow-up #1 (up to 72 weeks)
Subject Satisfaction Scale
Time frame: Baseline to Follow-up #1 (up to 72 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Vbeam Pro Laser Treatment in people with Rosacea and Vascular Diseases, run by Candela Corporation.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maya Duffy ((508) 358-7400, mayajade.duffy@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clearance of Vascular Lesion (time frame: Baseline to Follow-up #1 (up to 72 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2025; AzTrials last refreshed its copy on 26 Oct 2026.