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Trial record 44 of 82 for:    acne AND Acne Scars

Fractional Resurfacing Device for Treatment of Acne Scarring

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: NCT00585286
Recruitment Status : Completed
First Posted : January 3, 2008
Results First Posted : December 2, 2013
Last Update Posted : January 15, 2014
Sponsor:
Collaborators:
Reliant Technologies, Inc. Mountain View, CA
University of Minnesota - Clinical and Translational Science Institute
Information provided by (Responsible Party):
Christopher Zachary, University of California, Irvine

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Acne
Scar
Intervention Device: 10,600 nm fractional carbon dioxide laser system
Enrollment 15
Recruitment Details 30 total patients with moderate to severe acne scarring were recruited from 3/2007-5/2008 between two locations. Of these, 15 patients received treatment and 14 patients completed the full course of the study at the University of California, Irvine General Clinical Research Center.
Pre-assignment Details Subjects must not have been treated with other lasers, chemical procedures, or other cosmetic procedures on the area to be treated within 12 months of enrollment.
Arm/Group Title Fractional Carbon Dioxide Laser System
Hide Arm/Group Description Fifteen healthy subjects of skin type I-IV received treatment with the 10,600 nm fractional carbon dioxide laser system.
Period Title: Overall Study
Started 15
Completed 14
Not Completed 1
Reason Not Completed
Lost to Follow-up             1
Arm/Group Title Fractional CO2 Laser System
Hide Arm/Group Description Thirty healthy subjects of skin type I-IV received treatment with the 10,600 nm fractional CO2 laser system.
Overall Number of Baseline Participants 15
Hide Baseline Analysis Population Description
Of 30 patients enrolled between two research centers, 15 subjects were enrolled at the UC Irvine General Clinical Research Center
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
<=18 years
0
   0.0%
Between 18 and 65 years
15
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 15 participants
36  (13)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
Female
9
  60.0%
Male
6
  40.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 15 participants
15
1.Primary Outcome
Title Overall Improvement of Acne Scarring
Hide Description Subject assessment of the percent improvement of acne scarring compared to baseline and based on the quartile scale (0: no improvement; 1: 1–25% improvement; 2: 26–50%; 3: 51–75%; 4: 76–100% improvement).
Time Frame Baseline, 1 month and 3 months post-treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Out of 15 subjects enrolled at our site, one was lost to follow up before the 3 month follow up for the first treatment. Therefore, data was analyzed for the 14 patients that completed the study.
Arm/Group Title Fractional CO2 Laser System
Hide Arm/Group Description:
Fifteen healthy subjects of skin type I-IV received treatment with the 10,600 nm fractional CO2 laser system.
Overall Number of Participants Analyzed 14
Mean (Standard Deviation)
Unit of Measure: units on a scale
Month 1 2.26  (1.15)
Month 3 1.91  (1.0)
2.Primary Outcome
Title Average Improvement in Surface Texture
Hide Description Subject assessment of the percent improvement of surface texture compared to baseline and based on the quartile scale (0: no improvement; 1: 1–25% improvement; 2: 26–50%; 3: 51–75%; 4: 76–100% improvement).
Time Frame Baseline, 1 month and 3 months post-treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Out of 15 subjects enrolled at our site, one was lost to follow up before the 3 month follow up for the first treatment. Therefore, data was analyzed for the 14 patients that completed the study.
Arm/Group Title Fractional CO2 Laser System
Hide Arm/Group Description:
Fifteen healthy subjects of skin type I-IV received treatment with the 10,600 nm fractional CO2 laser system.
Overall Number of Participants Analyzed 14
Median (Standard Deviation)
Unit of Measure: units on a scale
Month 1 1.94  (1.16)
Month 3 2.09  (0.85)
3.Primary Outcome
Title Degree of Atrophy
Hide Description Subject assessment of the percent improvement in extent of atrophy compared to baseline and based on the quartile scale (0: no improvement; 1: 1–25% improvement; 2: 26–50%; 3: 51–75%; 4: 76–100% improvement).
Time Frame Baseline, 1 month and 3 months post-treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Out of 15 subjects enrolled at our site, one was lost to follow up before the 3 month follow up for the first treatment. Therefore, data was analyzed for the 14 patients that completed the study.
Arm/Group Title Fractional CO2 Laser System
Hide Arm/Group Description:
Fifteen healthy subjects of skin type I-IV received treatment with the 10,600 nm fractional CO2 laser system.
Overall Number of Participants Analyzed 14
Median (Standard Deviation)
Unit of Measure: units on a scale
Month 1 1.68  (1.11)
Month 3 1.65  (1.14)
4.Secondary Outcome
Title Pain Tolerance
Hide Description The average pain score reported over all three treatments was 5.67, corresponding to "moderate" pain based on a 10-point scale. The pain score is recorded on a 10-point scale, with 0 being "no pain" and 10 being "worst pain imaginable." All subjects reported that any discomfort associated with the procedure was only during active intervention and resolved immediately post-procedure. Increased pain scores correlated with increased density, but not increased energy.
Time Frame At treatment visit (up to 3 visits)
Hide Outcome Measure Data
Hide Analysis Population Description
Out of 15 subjects enrolled at our site, one was lost to follow up before the 3 month follow up for the first treatment. Therefore, data was analyzed for the 14 patients that completed the study.
Arm/Group Title Fractional CO2 Laser System
Hide Arm/Group Description:
Fifteen healthy subjects of skin type I-IV received treatment with the 10,600 nm fractional CO2 laser system.
Overall Number of Participants Analyzed 14
Mean (Standard Deviation)
Unit of Measure: units on a scale
5.67  (0.833)
Time Frame Adverse event data was collected over the entire study for approximately 1 year and 3 months.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Fractional CO2 Laser System
Hide Arm/Group Description Fifteen healthy subjects of skin type I-IV received treatment with the 10,600 nm fractional CO2 laser system.
All-Cause Mortality
Fractional CO2 Laser System
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Fractional CO2 Laser System
Affected / at Risk (%)
Total   0/15 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Fractional CO2 Laser System
Affected / at Risk (%)
Total   0/15 (0.00%) 
There were no major limitations to this trial. The trial was completed without any technical problems or major complications.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Name/Title: Christopher Zachary, FRCP, MBBS/Prinicipal Investigator
Organization: University of California, Irvine
Phone: (949) 824-7103
Responsible Party: Christopher Zachary, University of California, Irvine
ClinicalTrials.gov Identifier: NCT00585286     History of Changes
Other Study ID Numbers: 2006-5328
First Submitted: December 26, 2007
First Posted: January 3, 2008
Results First Submitted: June 17, 2011
Results First Posted: December 2, 2013
Last Update Posted: January 15, 2014