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

NCT00887913 | Completed Results

• 1 other identifier: Matrix RF_Facial Tx
• Study Type: interventional
• Target: 69
• Locations: 2 countries
• Sites: 3

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.

Conditions

Skin Resurfacing; Wrinkle Reduction

Outcome Measures

Primary Outcomes (3)

• Improvement in Fine Lines

  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

  4 week follow up after last treatment

• Improvement in Smoothness

  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

  4 weeks follow up post last treatment

• Improvement in Brightness

  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

  4 week follow up post last treatment

Interventions

Fractional RF treatment with Matrix RF applicator DEVICE

3 treatments, single pass, 2-50J

Also known as: Matrix RF Applicator

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• 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 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Syneron Medical: lead

Study Sites (3)

Advanced Dermatology

Lincolnshire, Illinois, 60069, United States

Location

Laser and Dermatology Surgery Center

Chesterfield, Missouri, 63017, United States

Location

Laserderm

Ottawa, Ontario, K1Z 1G3, Canada

Location

Results Point of Contact

• Title: Hanit Brenner-Lavie
• Organization: Syneron Medical Ltd

hanitb@syneron.com

972-73-244-2200

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 23, 2009
• First Posted: April 24, 2009
• Study Start: April 1, 2008
• Primary Completion: December 1, 2008
• Study Completion: October 1, 2009
• Last Updated: November 30, 2010
• Results First Posted: November 30, 2010

Record last verified: 2010-11

Locations

US (2); CA (1)