Port Wine Stains Treatment Matrix RF Study

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by Syneron Medical.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Syneron Medical
ClinicalTrials.gov Identifier:
NCT01101360
First received: April 7, 2010
Last updated: May 4, 2011
Last verified: May 2011
  Purpose

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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Evaluation of Fractional Radiofrequency (Matrix RF) Stand Alone and Combined With PDL Treatment on Port Wine Stains

Further study details as provided by Syneron Medical:

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

  • Adverse events recording and monitoring [ Time Frame: Up to 40 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Clearance of port wine stain [ Time Frame: Up to 40 weeks ] [ Designated as safety issue: No ]
  • Lightening of the port wine stain [ Time Frame: Up to 40 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Assessment to be done by the subject via subject questionnaire during these visits

  • Reduction in blood vessel concentration [ Time Frame: Up to 40 weeks ] [ Designated as safety issue: No ]
    Biopsies taken from consenting subjects at one of the time points will be analyzed


Estimated Enrollment: 20
Study Start Date: March 2010
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    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)
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  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: NCT01101360

Locations
United States, New York
Laser and Skin Surgery Center of New York Recruiting
New York, New York, United States, 10016
Contact: Jennifer Moreno    212-686-7306    jmoreno@laserskinsurgery.com   
Principal Investigator: Roy Geronemus, MD         
Sponsors and Collaborators
Syneron Medical
  More Information

No publications provided

Responsible Party: Ruthie Amir, Syneron Medical Ltd
ClinicalTrials.gov Identifier: NCT01101360     History of Changes
Other Study ID Numbers: DC75761
Study First Received: April 7, 2010
Last Updated: May 4, 2011
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Port-Wine Stain
Skin Abnormalities
Congenital Abnormalities
Skin Diseases

ClinicalTrials.gov processed this record on July 24, 2014