EVALUATION OF THE EFFECT OF THE PERFECTA V-BEAM LASER ON ROSACEA

NCT ID: NCT03211585

Last Updated: 2017-07-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-31
• Study Completion Date: 2018-12-31

Brief Summary

The purpose of this study is to further quantify the safety and effectiveness of the Syneron-Candela long pulse-duration, extended sub-pulse, larger spot-size prototype Perfecta V-Beam, 595nm laser system for the treatment of facial redness associated with flushing and blushing, or rosacea. The Perfecta laser system is expected to provide effective treatment of rosacea with less bruising or purpura and greater effectiveness than previous generation systems. This study should enable optimization of treatment parameters for using the Perfecta 595nm laser for treating rosacea.

Conditions

Rosacea

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Perfecta V-Beam laser

This s a single study and a prototype of the FDA-cleared, flashlamp-pumped pulsed-dye laser, that is currently on the market, that has evolved over almost 25 years of continuous development. The broad-spectrum flashlamp pumps energy into a cavity containing liquid dye. The dye is excited resulting in the emission of 595 nm orange light.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Subjects must have a Fitzpatrick skin type of I-IV and have Rosacea as evaluated by the treating physician.
• Subjects must have visible telangiectasia on the side of the face.
• Subjects must be willing and able to comply with all follow-up requirements.
• Subjects must be willing and able to apply sunblock SPF of 30 while exposed to the sun.
• Subject willing to have photographs taken and used in presentations or publications.

Exclusion Criteria

• Subjects must not have had a previous laser treatment, deep chemical peel in the intended treatment site(s) within 6 months prior to treatment, oral retinoids within 6 months of their inclusion into this study or have ever taken gold therapy.
• Subjects must not have a history of keloid formation.
• Subjects with Fitzpatrick Classification of V or VI (to reduce the risk of hyper-pigmentation).
• Subjects must be willing and able to comply with all follow-up requirements.
• Subjects cannot have vitiligo, a condition where pigment is lost in the skin and white patches appear).
• Subjects not willing to avoid sun exposure or not will to apply sunblock SPF of 30 while exposed to the sun.
• Subject not willing to have photographs taken and used in presentations, publications and marketing material

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Syneron Medical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eric Bernstein, MD

Role: PRINCIPAL_INVESTIGATOR

Main Line Center for Laser Surgery

Other Identifiers

2016-01

Identifier Type: -

Identifier Source: org_study_id