Port Wine Stains Treatment Matrix RF Study



Status:Recruiting
Healthy:No
Age Range:18 - 65
Updated:2/7/2015
Start Date:March 2010

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

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.


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.
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