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

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Syneron Medical

ClinicalTrials.gov Identifier:

NCT03211585

First received: July 5, 2017

Last updated: NA

Last verified: July 2017

History: No changes posted

Purpose

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.

Condition	Intervention
Rosacea	Device: Perfecta V-Beam laser


Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: No masking Primary Purpose: Treatment
Official Title:	EVALUATION OF THE EFFECT OF THE PERFECTA V-BEAM LASER ON ROSACEA (FACIAL REDNESS, TELANGIECTASIAS AND PHOTODAMAGE)

Resource links provided by NLM:

MedlinePlus related topics: Rosacea

U.S. FDA Resources

Further study details as provided by Syneron Medical:

Primary Outcome Measures:

The percentage reduction in the facial redness and telangiectasias of rosacea [ Time Frame: two months following the final treatment ]
The percentage reduction in the facial redness and telangiectasias of rosacea will be determined by the investigators using polarized photography for each subject


Enrollment:	20
Actual Study Start Date:	October 2016
Estimated Study Completion Date:	December 2018
Estimated Primary Completion Date:	April 2018 (Final data collection date for primary outcome measure)

Intervention Details:

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.

Single arm study.

Eligibility


Ages Eligible for Study:	18 Years to 70 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03211585

Sponsors and Collaborators

Syneron Medical

Investigators


Principal Investigator:	Eric Bernstein, MD	Main Line Center for Laser Surgery

More Information


Responsible Party:	Syneron Medical
ClinicalTrials.gov Identifier:	NCT03211585 History of Changes
Other Study ID Numbers:	2016-01
Study First Received:	July 5, 2017
Last Updated:	July 5, 2017


Studies a U.S. FDA-regulated Drug Product:		No
Product Manufactured in and Exported from the U.S.:		No

Additional relevant MeSH terms:


Rosacea Skin Diseases

ClinicalTrials.gov processed this record on July 11, 2017

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