Back to resultsEVALUATION OF THE EFFECT OF THE PERFECTA V-BEAM LASER ON ROSACEA
Primary Purpose
Rosacea
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Perfecta V-Beam laser
Sponsored by
About this trial
This is an interventional treatment trial for Rosacea
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
Sites / Locations
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03211585
Brief Title
EVALUATION OF THE EFFECT OF THE PERFECTA V-BEAM LASER ON ROSACEA
Official Title
EVALUATION OF THE EFFECT OF THE PERFECTA V-BEAM LASER ON ROSACEA (FACIAL REDNESS, TELANGIECTASIAS AND PHOTODAMAGE)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Unknown status
Study Start Date
October 2016 (Actual)
Primary Completion Date
April 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Syneron Medical
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rosacea
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Perfecta V-Beam laser
Intervention Description
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 Measure Information:
Title
The percentage reduction in the facial redness and telangiectasias of rosacea
Description
The percentage reduction in the facial redness and telangiectasias of rosacea will be determined by the investigators using polarized photography for each subject
Time Frame
two months following the final treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Bernstein, MD
Organizational Affiliation
Main Line Center for Laser Surgery
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
EVALUATION OF THE EFFECT OF THE PERFECTA V-BEAM LASER ON ROSACEA
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