Port-Wine Stain, Rosacea, Vascular Diseases
Conditions
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.
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 1. Screening and Enrollment Visit 2. Up to Three (3) Treatment Visits (with treatment intervals from 2 weeks to 6 weeks). 3. 7 Day (+/- 5 days) Follow Up Visit following Each Treatment Session (may be a virtual telephone or video visit) 4. 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 1. Screening and Enrollment Visit 2. Treatment visits are limited to up to eight (8) study treatments (with treatment intervals from 1 week to 8 weeks). 3. Follow-up #1 (4 weeks - 8 weeks) 4. Follow-up #2 (8 weeks - 16 weeks) (optional) Additional follow up visits may be added, if necessary, per Sponsor and investigators' discretion.
Interventions
DEVICEVbeam Pro Laser Treatment
Treatment with Vbeam Pro Laser System
Sponsors
Candela Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Treatment Group with Vbeam Pro Pulse Dye Laser
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Healthy subjects aged 18 years or older 2. Presence of one or more vascular lesion, cutaneous lesion, or other dermatological condition deemed fit for treatment 3. Able and willing to comply with the treatment/follow-up schedule and comply with all study (protocol) requirements. 4. Willing to provide signed, informed consent to participate in the study 5. Willing to have photographs and images taken of the treated areas to be used in evaluations, publications, presentations, and marketing materials
Exclusion criteria
1. Pregnant or planning to become pregnant, having given birth less than 3 months prior to enrollment into the study, and/or breast feeding 2. Known photosensitivity to 595nm or 1064 nm light 3. History of light-induced seizure disorders 4. Severe unstable concurrent conditions, such as unstable cardiac disorders 5. 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) 6. 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) 7. Tattoos (including decorative, permanent makeup and radiation port tattoos) in the intended study treatment area (595nm use only) 8. Active Herpes Simplex Virus (HSV) in the intended treatment area unless treated with prophylactic medication 9. The intended treatment area has significant sun exposure within the past 2 weeks or self-tanner has been applied to the treatment area 10. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clearance of Vascular Lesion | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Investigator Global Aesthetic Improvement Scale | Baseline to Follow-up #1 (up to 72 weeks) | 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 |
| Subject Satisfaction Scale | Baseline to Follow-up #1 (up to 72 weeks) | Evaluation of subject satisfaction following the treatment series for treatment areas or comparing split treatment areas. |
Contacts
Primary ContactMaya Duffy
Outcome results
None listed