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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | December 26, 2007 | ||||
| Last Updated Date | October 27, 2008 | ||||
| Start Date ICMJE | March 2007 | ||||
| Primary Completion Date | July 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Overall improvement of acne scarring [ Time Frame: 72 hours, 1 week, 1 month and 3 months post-treatment ] [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00585286 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Fractional Resurfacing Device for Treatment of Acne Scarring | ||||
| Official Title ICMJE | Evaluation of a Novel Fractional Resurfacing Device for the Treatment of Acne Scarring | ||||
| Brief Summary | The purpose of this research study is to evaluate the safety and effectiveness of a new investigational laser device for treatment of acne scarring, for improvement in the appearance of surface texture and topography (recessed or uneven surfaces). |
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| Detailed Description | Fifteen subjects with an acne scar severity score greater than 4 will receive up to 3 treatments with an FDA IDE and IRB approved 10,600nm fractional CO2 laser system. Improvement of acne scarring is evaluated at 72 hours, 1 week, 1 month and 3 months post-treatment. Post-treatment responses evaluated are immediate erythema, immediate edema, and any other immediate responses. Evaluations are conducted immediate post treatment and one week post-treatment. Key safety data include the severity scoring of post-treatment responses, as well as by photodocumentation. The incidence of side effects such as scarring, pigmentary changes, etc. are evaluted at follow-up visits one and three months post-treatment. Key safety data include the incidence rates and severity scoring of side effects, as well as by photodocumentation |
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| Study Phase | Phase I, Phase II | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study | ||||
| Condition ICMJE | Acne Scarring | ||||
| Intervention ICMJE | Device: 10,600 nm fractional CO2 laser system | ||||
| Study Arms / Comparison Groups | Experimental: Fractional CO2 laser treatment | ||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 15 | ||||
| Completion Date | July 2008 | ||||
| Primary Completion Date | July 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 30 Years to 75 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00585286 | ||||
| Responsible Party | Christopher B. Zachary, MBBS, FRCP, University of California, Irvine | ||||
| Study ID Numbers ICMJE | 2006-5328 | ||||
| Study Sponsor ICMJE | University of California, Irvine | ||||
| Collaborators ICMJE | Reliant Technologies, Inc. Mountain View, CA | ||||
| Investigators ICMJE |
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| Information Provided By | University of California, Irvine | ||||
| Verification Date | July 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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