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

EVALUATION OF THE EFFECT OF THE PERFECTA V-BEAM LASER ON ROSACEA (FACIAL REDNESS, TELANGIECTASIAS AND PHOTODAMAGE)

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.

Study Overview

• Status: Unknown
• Conditions: Rosacea
• Intervention / Treatment: Device: Perfecta V-Beam laser

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Syneron Medical

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2016
• Primary Completion (Anticipated): April 1, 2018
• Study Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: July 5, 2017
• First Submitted That Met QC Criteria: July 5, 2017
• First Posted (Actual): July 7, 2017

Study Record Updates

• Last Update Posted (Actual): July 12, 2017
• Last Update Submitted That Met QC Criteria: July 9, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Rosacea
• Other Study ID Numbers: 2016-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• product manufactured in and exported from the U.S.: No