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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | November 1, 2006 | ||||
| Last Updated Date | October 4, 2007 | ||||
| Start Date ICMJE | October 2006 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
Active and inactive lesion count [ Time Frame: 0,1,2,3,4,8,16 weeks ] | ||||
| Original Primary Outcome Measures ICMJE |
Active and inactive lesion count | ||||
| Change History | Complete list of historical versions of study NCT00395187 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Regional disease severity will be assessed at each visit. Global Severity Score will be assigned by investigator. Assessed at all 6 visits, Patient self -assessment (DLQI) at visits 4-6,-Digital photographs-all 6 visits,Safety/adverse event monitoring. [ Time Frame: 0,1,2,3,4,8,16 weeks ] | ||||
| Original Secondary Outcome Measures ICMJE |
Regional disease severity will be assessed at each visit. Global Severity Score will be assigned by investigator. Assessed at all 6 visits, Patient self -assessment (DLQI) at visits 4-6,-Digital photographs-all 6 visits,Safety/adverse event monitoring. | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | A Small Clinical Study: Photodynamic Therapy to Treat Hidradenitis Suppurativa | ||||
| Official Title ICMJE | A Small Clinical Study: Photodynamic Therapy to Treat Hidradenitis Suppurativa | ||||
| Brief Summary | This study will investigate the efficacy of Photodynamic Therapy (PDT), which is the therapeutic use of photochemical reactions, in treating hidradenitis suppurativa (HS), a chronic inflammatory condition affecting areas of skin with sweat glands. We expect that PDT is effective in treating HS. |
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| Detailed Description | This study will investigate the efficacy of PDT using aminolevulinic acid (ALA) and either blue light or intense pulsed light on active lesions of HS. We will attempt to validate the success noted in a previously published case series using PDT with ALA and blue light (Gold, Bridges et al). We will evaluate effect of treatment by number of lesions, global disease severity, and patient self-assessment with the Dermatology Life Quality Index (DLQI). Detailed informed consent will be obtained prior to treatment at study enrollment. The first four treatment visits will involve clinical evaluation, photography and application of the ALA to the affected area. After a 45 minute incubation period, the area will be washed and then treated with either blue light or intense pulsed light (IPL), depending on body area/investigator choice. One and three-month follow-up visits will involve evaluation of efficacy, but no active treatment. Gold M, Bridges TM, et al. ALA-PDT and blue light therapy for hidradenitis suppurative. J Drugs Dermatol. 2004; 3 (1 Suppl):S32-5. |
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| Study Phase | |||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study | ||||
| Condition ICMJE | Hidradenitis Suppurativa | ||||
| Intervention ICMJE | Procedure: Photodynamic Therapy | ||||
| Study Arms / Comparison Groups | |||||
| 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 | ||||
| Estimated Enrollment ICMJE | 15 | ||||
| Completion Date | September 2007 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 55 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 | NCT00395187 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | 10514 | ||||
| Study Sponsor ICMJE | University of Kansas | ||||
| Collaborators ICMJE | DUSA Pharmaceuticals, Inc. | ||||
| Investigators ICMJE |
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| Information Provided By | University of Kansas | ||||
| Verification Date | October 2007 | ||||
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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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