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Port Wine Stains Treatment Matrix RF Study

This study has been completed.
Information provided by (Responsible Party):
Syneron Medical Identifier:
First received: April 7, 2010
Last updated: November 30, 2014
Last verified: November 2014
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.

Condition Intervention
Port Wine Stains
Device: Matrix RF
Device: Matrix RF followed by Pulse Dye Laser
Device: Pulse Dye Laser followed by Matrix RF

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Single Blind (Participant)
Primary Purpose: Treatment
Official Title: Evaluation of Fractional Radiofrequency (Matrix RF) Stand Alone and Combined With PDL Treatment on Port Wine Stains

Resource links provided by NLM:

Further study details as provided by Syneron Medical:

Primary Outcome Measures:
  • Time to complete healing [ Time Frame: Up to 30 weeks ]
    Assess safety of the Matrix RF treatment for port wine stains

  • Adverse events recording and monitoring [ Time Frame: Up to 40 weeks ]

Secondary Outcome Measures:
  • Clearance of port wine stain [ Time Frame: Up to 40 weeks ]
  • Lightening of the port wine stain [ Time Frame: Up to 40 weeks ]
    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.

  • Improvement of port wine stain [ Time Frame: Up to 30 weeks ]
    Assessment to be done by the subject via subject questionnaire during these visits

  • Reduction in blood vessel concentration [ Time Frame: Up to 40 weeks ]
    Biopsies taken from consenting subjects at one of the time points will be analyzed

Enrollment: 10
Study Start Date: March 2010
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Matrix RF followed by Pulse Dye Laser Device: Matrix RF
Section of port wine stain to be treated 5 times every 5 weeks (+/- 1 week)
Device: Matrix RF followed by Pulse Dye Laser
Section of port wine stain to be treated 5 times every 5 weeks (+/- 1 week)
Device: Pulse Dye Laser followed by Matrix RF
Section of port wine stain to be treated 5 times every 5 weeks (+/- 1 week)


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT01101360

United States, New York
Laser and Skin Surgery Center of New York
New York, New York, United States, 10016
Sponsors and Collaborators
Syneron Medical
  More Information

Responsible Party: Syneron Medical Identifier: NCT01101360     History of Changes
Other Study ID Numbers: DC75761
Study First Received: April 7, 2010
Last Updated: November 30, 2014

Keywords provided by Syneron Medical:
port wine stains
Pulse Dye Laser

Additional relevant MeSH terms:
Port-Wine Stain
Hemangioma, Capillary
Vascular Malformations
Skin Abnormalities
Congenital Abnormalities
Skin Diseases
Neoplasms, Vascular Tissue
Neoplasms by Histologic Type
Cardiovascular Abnormalities
Cardiovascular Diseases processed this record on May 25, 2017