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| Tracking Information | |||||
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| First Received Date ICMJE | August 19, 2006 | ||||
| Last Updated Date | May 7, 2009 | ||||
| Start Date ICMJE | April 2005 | ||||
| Primary Completion Date | April 2006 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
A successful treatment is expected to improve the quality of life significantly by causing remission of disease. The data obtained from this study will also allow the development of laser-based treatment protocols for hidradenitis suppurativa. [ Time Frame: 1 year ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
A successful treatment is expected to improve the quality of your life significantly by causing remission of your disease. The data obtained from this study will also allow the development of laser based treatment protocols for hidradenitis suppurativa. | ||||
| Change History | Complete list of historical versions of study NCT00367328 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | To Determine the Efficacy of a Laser Device for the Treatment of Hidradenitis Suppurativa | ||||
| Official Title ICMJE | To Determine The Efficacy Of A 1320nm Nd: YAG Nonablative Laser For Treatment of Hidradenitis Suppurativa | ||||
| Brief Summary | A research study to determine the efficacy of a 1320 nm laser device for the treatment of hidradenitis suppurativa. |
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| Detailed Description | Hidradenitis Suppurativa is a chronic, scarring disease. The treatments available for this condition are not very effective and work only for some patients. Recently, a 1320nm laser device has been approved by the FDA for the treatment of acne and facial rejuvenation. Given the positive results seen with the use of this laser in the treatment of acne it is reasonable to hypothesize that a similar effect may be seen with the treatment of Hidradenitis suppurativa. The specific aim of the study is to determine the efficacy of this device for the treatment of hidradenitis suppurativa as it relates to the patient's established treatment. The investigators are trying to determine the efficacy of a laser for the treatment of hidradenitis suppurativa. Patients will:
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| Study Phase | Phase III | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study | ||||
| Condition ICMJE | Hidradenitis Suppurativa | ||||
| Intervention ICMJE | Device: 1320nm Nd: YAG nonablative laser | ||||
| Study Arms / Comparison Groups | Active Comparator: Oral Antibiotics in standard care vs. 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 | Terminated | ||||
| Enrollment ICMJE | 10 | ||||
| Completion Date | April 2006 | ||||
| Primary Completion Date | April 2006 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00367328 | ||||
| Responsible Party | Daniel Eisen, M.D., UC Davis | ||||
| Study ID Numbers ICMJE | 200513081-1 | ||||
| Study Sponsor ICMJE | University of California, Davis | ||||
| Collaborators ICMJE | CoolTouch, Inc | ||||
| Investigators ICMJE |
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| Information Provided By | University of California, Davis | ||||
| Verification Date | May 2009 | ||||
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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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