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

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ClinicalTrials.gov Identifier: NCT00887913
Recruitment Status : Completed
First Posted : April 24, 2009
Results First Posted : November 30, 2010
Last Update Posted : November 30, 2010
Sponsor:
Information provided by:
Syneron Medical

Tracking Information
First Submitted Date  ICMJE April 23, 2009
First Posted Date  ICMJE April 24, 2009
Results First Submitted Date  ICMJE October 6, 2010
Results First Posted Date  ICMJE November 30, 2010
Last Update Posted Date November 30, 2010
Study Start Date  ICMJE April 2008
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 2, 2010)
  • Improvement in Fine Lines [ Time Frame: 4 week follow up after last treatment ]
    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 ]
    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 ]
    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
Original Primary Outcome Measures  ICMJE
 (submitted: April 23, 2009)
  • Fitzpatrick wrinkles scale [ Time Frame: Following Tx1, 3 and at Follow-up visits ]
  • Comfort level Adverse Event [ Time Frame: At each treatment visit ]
Change History Complete list of historical versions of study NCT00887913 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Study to Evaluate the Performance of Fractional Radiofrequency for Improvement of Skin Texture Via Skin Resurfacing and Wrinkles Reduction
Official Title  ICMJE Clinical Study to Evaluate the Performance of Fractional Radiofrequency for Improvement of Skin Texture Via Skin Resurfacing and Wrinkles Reduction
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Skin Resurfacing
  • Wrinkle Reduction
Intervention  ICMJE Device: Fractional RF treatment with Matrix RF applicator
3 treatments, single pass, 2-50J
Other Name: Matrix RF Applicator
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 2, 2010)
69
Original Estimated Enrollment  ICMJE
 (submitted: April 23, 2009)
120
Actual Study Completion Date  ICMJE October 2009
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00887913
Other Study ID Numbers  ICMJE Matrix RF_Facial Tx
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Yehudit Kraizer, Syneron Medical
Study Sponsor  ICMJE Syneron Medical
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Syneron Medical
Verification Date November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP