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

NCT03211585 | Unknown

• 1 other identifier: 2016-01
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• The percentage reduction in the facial redness and telangiectasias of rosacea

  The percentage reduction in the facial redness and telangiectasias of rosacea will be determined by the investigators using polarized photography for each subject

  two months following the final treatment

Interventions

Perfecta V-Beam laser DEVICE

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.

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Syneron Medical: lead

MeSH Terms

Conditions

Rosacea

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Eric Bernstein, MD

  Main Line Center for Laser Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2017
• First Posted: July 7, 2017
• Study Start: October 1, 2016
• Primary Completion: April 1, 2018
• Study Completion: December 1, 2018
• Last Updated: July 12, 2017

Record last verified: 2017-07