Port Wine Stains Treatment Matrix RF Study

NCT01101360 | Completed

• 1 other identifier: DC75761
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Keywords

port wine stains; radiofrequency; Pulse Dye Laser

Outcome Measures

Primary Outcomes (2)

• Time to complete healing

  Assess safety of the Matrix RF treatment for port wine stains

  Up to 30 weeks

• Adverse events recording and monitoring

  Up to 40 weeks

Secondary Outcomes (4)

• Clearance of port wine stain

  Up to 40 weeks

• Lightening of the port wine stain

  Up to 40 weeks

• Improvement of port wine stain

  Up to 30 weeks

• Reduction in blood vessel concentration

  Up to 40 weeks

Study Arms (1)

Matrix RF followed by Pulse Dye Laser

ACTIVE COMPARATOR

Device: Matrix RF; Device: Matrix RF followed by Pulse Dye Laser; Device: Pulse Dye Laser followed by Matrix RF

Interventions

Matrix RF DEVICE

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

Matrix RF followed by Pulse Dye Laser

Matrix RF followed by Pulse Dye Laser DEVICE

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

Matrix RF followed by Pulse Dye Laser

Pulse Dye Laser followed by Matrix RF DEVICE

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

Matrix RF followed by Pulse Dye Laser

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Syneron Medical: lead

Study Sites (1)

Laser and Skin Surgery Center of New York

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Hemangioma, Capillary

Condition Hierarchy (Ancestors)

Hemangioma; Neoplasms, Vascular Tissue; Neoplasms by Histologic Type; Neoplasms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2010
• First Posted: April 9, 2010
• Study Start: March 1, 2010
• Primary Completion: September 1, 2011
• Last Updated: December 2, 2014

Record last verified: 2014-11

Locations

US (1)