To Determine the Efficacy of a Laser Device for the Treatment of Hidradenitis Suppurativa
This study has been terminated.
(Terminated: recruiting or enrolling participants has halted.)
Sponsor:
University of California, Davis
Collaborator:
CoolTouch, Inc
Information provided by:
University of California, Davis
ClinicalTrials.gov Identifier:
NCT00367328
First received: August 19, 2006
Last updated: May 7, 2009
Last verified: May 2009
| 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 | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| 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 Type ICMJE | Interventional | ||||
| Study Phase | Phase 3 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE | Hidradenitis Suppurativa | ||||
| Intervention ICMJE | Device: 1320nm Nd: YAG nonablative laser
a 4 mm piece of skin tissue (about the size of a pencil-head eraser) from the affected area. This procedure is called a punch biopsy and will be done to confirm your diagnosis. A culture swab similar to a Q-Tip will be used to wipe the affected areas during the first visit to determine any bacteria that may be present. A survey with questions will be given at the first visit, again after 3 months and at the last visit to measure the success of the treatment. Photographs will be taken prior to each treatment and one month following your last treatment. A laser, which is a very powerful light, will be used to treat half of the skin that is affected by your condition.
Other Name: laser treatment |
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| Study Arm (s) | Active Comparator: A
Oral Antibiotics in standard care vs. Laser treatment
Intervention: Device: 1320nm Nd: YAG nonablative laser |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) 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 Number ICMJE | NCT00367328 | ||||
| Other Study ID Numbers ICMJE | 200513081-1 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Daniel Eisen, M.D., UC Davis | ||||
| 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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