Port Wine Stains Treatment Matrix RF Study

Not Applicable

Completed

• Conditions: Port Wine Stains
• Interventions: Device: Matrix RF; Device: Matrix RF followed by Pulse Dye Laser; Device: Pulse Dye Laser followed by Matrix RF

• Registration Number: NCT01101360
• Lead Sponsor: Syneron Medical

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2010-04-07
• Study First Submitted QC: 2010-04-08
• Study First Posted: 2010-04-09
• Primary Completion: 2011-09
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-30
• Last Update Posted: 2014-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Matrix RF followed by Pulse Dye Laser	Matrix RF	-
Matrix RF followed by Pulse Dye Laser	Matrix RF followed by Pulse Dye Laser	-
Matrix RF followed by Pulse Dye Laser	Pulse Dye Laser followed by Matrix RF	-

Primary Outcome Measures

Name	Time	Method
Adverse events recording and monitoring	Up to 40 weeks
Time to complete healing	Up to 30 weeks	Assess safety of the Matrix RF treatment for port wine stains

Secondary Outcome Measures

Name	Time	Method
Lightening of the port wine stain	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.
Reduction in blood vessel concentration	Up to 40 weeks	Biopsies taken from consenting subjects at one of the time points will be analyzed
Clearance of port wine stain	Up to 40 weeks
Improvement of port wine stain	Up to 30 weeks	Assessment to be done by the subject via subject questionnaire during these visits

Trial Locations

Locations (1)

Laser and Skin Surgery Center of New York; 🇺🇸 New York, New York, United States