Clinical Study to Evaluate the Performance of Fractional Radiofrequency for Improvement of Skin Texture Via Skin Resurfacing and Wrinkles Reduction

This study has been completed.
Sponsor:
Information provided by:
Syneron Medical
ClinicalTrials.gov Identifier:
NCT00887913
First received: April 23, 2009
Last updated: November 2, 2010
Last verified: November 2010
  Purpose

The purpose of this study is to determine whether the Matrix RF applicator is effective in the treatment of facial skin texture and wrinkle reduction.


Condition Intervention
Skin Resurfacing
Wrinkle Reduction
Device: Fractional RF treatment with Matrix RF applicator

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical Study to Evaluate the Performance of Fractional Radiofrequency for Improvement of Skin Texture Via Skin Resurfacing and Wrinkles Reduction

Further study details as provided by Syneron Medical:

Primary Outcome Measures:
  • Improvement in Fine Lines [ Time Frame: 4 week follow up after last treatment ] [ Designated as safety issue: No ]

    Improvement of fine lines (wrinkles) assessed per anatomical area treated based on Improvement Scale: 0-4 where higher scores indicate a better outcome.

    Improvement is graded by means of photographs taken at baseline vs treatment 3 and baseline vs 6week follow up


  • Improvement in Smoothness [ Time Frame: 4 weeks follow up post last treatment ] [ Designated as safety issue: No ]

    Smoothness of anatomical treated area assessed based on Improvement Scale 0-4.Where higher scores indicate a better outcome.

    Improvement is graded by means of photographs taken at baseline vs treatment 3 and baseline vs 6week follow up


  • Improvement in Brightness [ Time Frame: 4 week follow up post last treatment ] [ Designated as safety issue: No ]

    Assess the improvement in brightness of the treated anatomical area using Improvement Scale where higher scores indicate a better outcome.

    Improvement is graded by means of photographs taken at baseline vs treatment 3 and baseline vs 6week follow up



Enrollment: 69
Study Start Date: April 2008
Study Completion Date: October 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Fractional RF treatment with Matrix RF applicator
    3 treatments, single pass, 2-50J
    Other Name: Matrix RF Applicator
  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Informed consent agreement signed by the subject.
  • Healthy males or females older than 21 years of age.
  • Having at least two facial sub-areas with visible lines/wrinkles and elastosis, which correlate to a score of 2 6 on the Fitzpatrick Classification of Wrinkling and Degree of Elastosis.
  • Fitzpatrick skin type I-VI (note: skin type VI should not undergo treatment using resurfacing procedure parameters).
  • Willingness to follow the treatment and follow-ups 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:

  • Pregnant or planning to become pregnant, having given birth less than 3 months ago, 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 metal plates and screws, or an injected chemical substance.
  • 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.
  • Having received acne treatment with a light-based device within 1 month of treatment or during the study.
  • Use of isotretinoin (Accutane®) within 6 months of treatment or during the study.
  • 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 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.
  • 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.
  • Having undergone a resurfacing procedure, face lift or eyelid surgery within a year of treatment or during the study.
  • 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: excessive skin dryness, psoriasis, eczema, rash, rosacea (particularly severe open wound stage), indurate acne, 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 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.
  • Vascular lesion, 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 one 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00887913

Locations
United States, Illinois
Advanced Dermatology
Lincolnshire, Illinois, United States, 60069
United States, Missouri
Laser and Dermatology Surgery Center
Chesterfield, Missouri, United States, 63017
Canada, Ontario
Laserderm
Ottawa, Ontario, Canada, K1Z 1G3
Sponsors and Collaborators
Syneron Medical
  More Information

No publications provided

Responsible Party: Yehudit Kraizer, Syneron Medical
ClinicalTrials.gov Identifier: NCT00887913     History of Changes
Other Study ID Numbers: Matrix RF_Facial Tx
Study First Received: April 23, 2009
Results First Received: October 6, 2010
Last Updated: November 2, 2010
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on April 15, 2014