Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    V-BEAM LASER ON ROSACEA
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03211585
Recruitment Status : Unknown
Verified July 2017 by Syneron Medical.
Recruitment status was:  Active, not recruiting
First Posted : July 7, 2017
Last Update Posted : July 12, 2017
Sponsor:
Information provided by (Responsible Party):
Syneron Medical

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.

Condition or disease Intervention/treatment Phase
Rosacea Device: Perfecta V-Beam laser Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: EVALUATION OF THE EFFECT OF THE PERFECTA V-BEAM LASER ON ROSACEA (FACIAL REDNESS, TELANGIECTASIAS AND PHOTODAMAGE)
Actual Study Start Date : October 2016
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Rosacea
MedlinePlus related topics: Rosacea


Intervention Details:
  • Device: 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.


Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03211585


Sponsors and Collaborators
Syneron Medical
Investigators
Layout table for investigator information
Principal Investigator: Eric Bernstein, MD Main Line Center for Laser Surgery
Layout table for additonal information
Responsible Party: Syneron Medical
ClinicalTrials.gov Identifier: NCT03211585    
Other Study ID Numbers: 2016-01
First Posted: July 7, 2017    Key Record Dates
Last Update Posted: July 12, 2017
Last Verified: July 2017

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Rosacea
Skin Diseases