Port Wine Stains Treatment Matrix RF Study

NCT ID: NCT01101360

Last Updated: 2014-12-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-03-31

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.

Conditions

Port Wine Stains

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Matrix RF followed by Pulse Dye Laser

Group Type: ACTIVE_COMPARATOR

Matrix RF

Intervention Type: DEVICE

Section of port wine stain to be treated 5 times every 5 weeks (+/- 1 week)

Matrix RF followed by Pulse Dye Laser

Intervention Type: DEVICE

Section of port wine stain to be treated 5 times every 5 weeks (+/- 1 week)

Pulse Dye Laser followed by Matrix RF

Intervention Type: DEVICE

Section of port wine stain to be treated 5 times every 5 weeks (+/- 1 week)

Interventions

Matrix RF

Section of port wine stain to be treated 5 times every 5 weeks (+/- 1 week)

Intervention Type: DEVICE

Matrix RF followed by Pulse Dye Laser

Section of port wine stain to be treated 5 times every 5 weeks (+/- 1 week)

Intervention Type: DEVICE

Pulse Dye Laser followed by Matrix RF

Section of port wine stain to be treated 5 times every 5 weeks (+/- 1 week)

Intervention Type: DEVICE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Syneron Medical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Laser and Skin Surgery Center of New York

New York, New York, United States

Countries

United States

Other Identifiers

DC75761

Identifier Type: -

Identifier Source: org_study_id