- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01101360
Port Wine Stains Treatment Matrix RF Study
November 30, 2014 updated by: Syneron Medical
Evaluation of Fractional Radiofrequency (Matrix RF) Stand Alone and Combined With PDL Treatment on Port Wine Stains
The purpose of this study is to evaluate the efficacy and safety of the Matrix RF for Port Wine Stains based on clinical and histological analyses.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
10
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New York
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New York, New York, United States, 10016
- Laser and Skin Surgery Center of New York
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Informed consent agreement signed by the subject.
- Healthy males or females older than 18 to 65 years of age.
- Having a low to mid depth Port Wine Stain of at least 5 cm2.
- Willingness to follow the treatment and follow-up schedule and the post-treatment care.
- For female candidates - post-menopausal or surgically sterilized, or using a medically acceptable form of birth control at least 3 months prior to enrollment and during the entire course of the study (i.e., oral contraceptives, IUD, contraceptive implant, barrier methods with spermicide, or abstinence).
Exclusion Criteria:
- PWS on lower legs or hands.
- Pregnant and/or breastfeeding.
- Having any active electrical implant anywhere in the body, such as a pacemaker or an internal defibrillator.
- Having a permanent implant in the treated area, such as an injected chemical substance in the face (if treated).
- Having a history of diseases stimulated by heat, such as recurrent Herpes Simplex in the treated area, unless treatment is conducted following a prophylactic regimen.
- Use of non-steroidal anti-inflammatory drugs (NSAIDS, e.g., ibuprofen-containing agents) one week before and after each treatment session.
- Use of retinoids, antioxidants or medical grade of skin nourishing supplements within 2 months of treatment or during the study.
- Having received a facial dermabrasion or chemical peel treatment within 3 months of treatment or during the study (if face is treated).
- Having received treatment with light, RF or other devices in the treated area within 6 months of treatment or during the study.
- Having received Botox/collagen/fat injections or other methods of augmentation with injected or implanted material in the treated area within 9 months of treatment or during the study (if face is treated).
- Having undergone a resurfacing procedure, face lift or eyelid surgery within a year of treatment or during the study (if face is treated).
- Having undergone any other surgery in the treated area within 6 months of treatment (or more if skin has not healed completely) or during the study.
- History of keloid scarring or of abnormal wound healing.
- Suffering from current or history of significant skin conditions in the treated area or inflammatory skin conditions, including, but not limited to: active acne, excessive skin dryness, psoriasis, eczema, rash, rosacea (particularly severe open wound stage), varicella scars, open lacerations or abrasions and active cold sores or herpes sores prior to treatment (duration of resolution as per the Investigator's discretion) or during the treatment course.
- History of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or currently using immunosuppressive medications.
- History of epidermal or dermal disorders (particularly if involving collagen or microvascularity).
- History of pigmentary disorders, particularly tendency for hyper- or hypo-pigmentation.
- Suffering from hormonal imbalance, as per the Investigator's discretion.
- Having a known anticoagulative or thromboembolic condition or taking anticoagulation medications one week prior to and during the treatment course (to allow inclusion, temporary cessation of use as per the subject's physician discretion).
- Having or undergoing any form of treatment for active cancer, or having a history of skin cancer or any other cancer in the areas to be treated, including actinic keratosis, presence of malignant or pre-malignant pigmented lesions.
- Suffering from significant concurrent illness, such as cardiac disorders, diabetes (type I or II), or pertinent neurological disorders.
- Tattoo or permanent make-up in the treated area.
- Excessively tanned in areas to be treated or unable/unlikely to refrain from tanning during the study.
- Participation in a study of another device or drug within three month prior to enrollment or during the study.
- As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Matrix RF followed by Pulse Dye Laser
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Section of port wine stain to be treated 5 times every 5 weeks (+/- 1 week)
Section of port wine stain to be treated 5 times every 5 weeks (+/- 1 week)
Section of port wine stain to be treated 5 times every 5 weeks (+/- 1 week)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to complete healing
Time Frame: Up to 30 weeks
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Assess safety of the Matrix RF treatment for port wine stains
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Up to 30 weeks
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Adverse events recording and monitoring
Time Frame: Up to 40 weeks
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Up to 40 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clearance of port wine stain
Time Frame: Up to 40 weeks
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Up to 40 weeks
|
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Lightening of the port wine stain
Time Frame: Up to 40 weeks
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Evaluation of lightening of the port wine stain will be made with reflectance spectrophotometer at all treatments and at 6 and 12 weeks following the last treatment.
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Up to 40 weeks
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Improvement of port wine stain
Time Frame: Up to 30 weeks
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Assessment to be done by the subject via subject questionnaire during these visits
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Up to 30 weeks
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Reduction in blood vessel concentration
Time Frame: Up to 40 weeks
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Biopsies taken from consenting subjects at one of the time points will be analyzed
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Up to 40 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2010
Primary Completion (Actual)
September 1, 2011
Study Registration Dates
First Submitted
April 7, 2010
First Submitted That Met QC Criteria
April 8, 2010
First Posted (Estimate)
April 9, 2010
Study Record Updates
Last Update Posted (Estimate)
December 2, 2014
Last Update Submitted That Met QC Criteria
November 30, 2014
Last Verified
November 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DC75761
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Port Wine Stains
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Centre Hospitalier Universitaire de NiceCompletedPort-wine StainsFrance
-
University of Lausanne HospitalsUnknownPort-wine Stains (PWS)
-
Henry VasconezGraceway Pharmaceuticals, LLCTerminated
-
University of California, IrvineBeckman Laser Institute University of California IrvineCompletedPort Wine StainsUnited States
-
University of California, IrvineBeckman Laser Institute University of California IrvineCompletedPort Wine StainsUnited States
-
Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co...CompletedPort-wine StainChina
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University of California, IrvineBeckman Laser Institute University of California IrvineCompletedPort-wine StainUnited States
-
University of California, IrvineBeckman Laser Institute University of California IrvineCompletedPORT WINE STAINUnited States
-
Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co...Completed
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Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co...Not yet recruitingPort-Wine Stain | Nevus Flammeus | Port-wine Birthmark
Clinical Trials on Matrix RF
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Syneron MedicalCompletedSkin Resurfacing | Wrinkle ReductionUnited States, Canada
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Syneron MedicalCompletedEvaluation of Non-ablative and Fractional Combination Treatment for Improvement in Skin's AppearanceLaser Therapy | Rejuvenation
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Home Skinovations Ltd.CompletedGingivitis | Plaque | Calculus, DentalUnited States
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GiMer MedicalCompletedLow Back Pain | Chronic Pain | Lower Limb PainTaiwan
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Venclose, Inc.CompletedChronic Venous InsufficiencyGermany
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BTL Industries Ltd.CompletedCircumferential Reduction | Waist Circumferential Reduction
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BTL Industries Ltd.CompletedPeriorbital Wrinkles
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Home Skinovations Ltd.Completed
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Home Skinovations Ltd.CompletedGingivitis | Plaque | Calculus, DentalUnited States
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Universita di VeronaBIOS s.r.l., Milano, ItalyCompleted