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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Skin Resurfacing
Wrinkle Reduction
Intervention Device: Fractional RF treatment with Matrix RF applicator
Enrollment 69
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Treatment
Hide Arm/Group Description Treatment group- undergo 3 treatments every 4-6 weeks
Period Title: Overall Study
Started 69
Completed 63
Not Completed 6
Reason Not Completed
Withdrawal by Subject             6
Arm/Group Title Treatment
Hide Arm/Group Description Treatment group- undergo 3 treatments every 4-6 weeks
Overall Number of Baseline Participants 69
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 69 participants
<=18 years
0
   0.0%
Between 18 and 65 years
65
  94.2%
>=65 years
4
   5.8%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 69 participants
51.02  (8.28)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 69 participants
Female
69
 100.0%
Male
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 69 participants
United States 45
Canada 24
1.Primary Outcome
Title Improvement in Fine Lines
Hide Description

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

Time Frame 4 week follow up after last treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol each defined anatomical area treated was assessed for improvement according to Improvement Scale- 0-4
Arm/Group Title Treatment
Hide Arm/Group Description:
Treatment group- undergo 3 treatments every 4-6 weeks
Overall Number of Participants Analyzed 63
Overall Number of Units Analyzed
Type of Units Analyzed: Fine Lines
162
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
1.77  (0.98)
2.Primary Outcome
Title Improvement in Smoothness
Hide Description

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

Time Frame 4 weeks follow up post last treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was per protocol, each area treated was graded on its improvement regarding the smoothness of the skin
Arm/Group Title Treatment
Hide Arm/Group Description:
Treatment group- undergo 3 treatments every 4-6 weeks
Overall Number of Participants Analyzed 63
Overall Number of Units Analyzed
Type of Units Analyzed: Smoothness
162
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
1.90  (1.05)
3.Primary Outcome
Title Improvement in Brightness
Hide Description

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

Time Frame 4 week follow up post last treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol, each anatomical area treated was assessed for skin brightness using the Improvement Scale of 0-4 where 0= 0%, 1= 1-25%, 2=26-50%, 3=51-75%, 4= 76-100% based on before and photographs. Maximum value grade is 4 and the minimum value grade is 0.
Arm/Group Title Treatment
Hide Arm/Group Description:
Treatment group- undergo 3 treatments every 4-6 weeks
Overall Number of Participants Analyzed 63
Overall Number of Units Analyzed
Type of Units Analyzed: Brightness
162
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
1.68  (1.18)
Time Frame Adverse event data was collected for the duration of the study, up to 5 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment
Hide Arm/Group Description Treatment group- undergo 3 treatments every 4-6 weeks
All-Cause Mortality
Treatment
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Treatment
Affected / at Risk (%)
Total   0/63 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Treatment
Affected / at Risk (%)
Total   0/63 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
PI is under a general confidentiality agreement and must have prior written approval by the Sponsor prior to publishing the study results.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Hanit Brenner-Lavie
Organization: Syneron Medical Ltd
Phone: 972-73-244-2200 ext 581
EMail: hanitb@syneron.com
Layout table for additonal information
Responsible Party: Yehudit Kraizer, Syneron Medical
ClinicalTrials.gov Identifier: NCT00887913     History of Changes
Other Study ID Numbers: Matrix RF_Facial Tx
First Submitted: April 23, 2009
First Posted: April 24, 2009
Results First Submitted: October 6, 2010
Results First Posted: November 30, 2010
Last Update Posted: November 30, 2010