Port Wine Stains Treatment Matrix RF Study

Port Wine Stains Clinical Trial

Official title:

Evaluation of Fractional Radiofrequency (Matrix RF) Stand Alone and Combined With PDL Treatment on Port Wine Stains

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01101360
• Other study ID #: DC75761
• Status: Completed
• Phase: N/A
• First received: April 7, 2010
• Last updated: November 30, 2014
• Start date: March 2010

Study information

• Verified date: November 2014
• Source: Syneron Medical
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hemangioma, Capillary
• Port Wine Stains
• Port-Wine Stain
• Vascular Malformations

Intervention

Device:
• Matrix RF
Section of port wine stain to be treated 5 times every 5 weeks (+/- 1 week)
• Matrix RF followed by Pulse Dye Laser
Section of port wine stain to be treated 5 times every 5 weeks (+/- 1 week)
• Pulse Dye Laser followed by Matrix RF
Section of port wine stain to be treated 5 times every 5 weeks (+/- 1 week)

Locations

Country	Name	City	State
United States	Laser and Skin Surgery Center of New York	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Syneron Medical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to complete healing	Assess safety of the Matrix RF treatment for port wine stains	Up to 30 weeks	Yes
Primary	Adverse events recording and monitoring		Up to 40 weeks	Yes
Secondary	Clearance of port wine stain		Up to 40 weeks	No
Secondary	Lightening of the port wine stain	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.	Up to 40 weeks	No
Secondary	Improvement of port wine stain	Assessment to be done by the subject via subject questionnaire during these visits	Up to 30 weeks	No
Secondary	Reduction in blood vessel concentration	Biopsies taken from consenting subjects at one of the time points will be analyzed	Up to 40 weeks	No