A Small Clinical Study: Photodynamic Therapy to Treat Hidradenitis Suppurativa
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|ClinicalTrials.gov Identifier: NCT00395187|
Recruitment Status : Completed
First Posted : November 2, 2006
Last Update Posted : October 10, 2007
|Condition or disease||Intervention/treatment||Phase|
|Hidradenitis Suppurativa||Procedure: Photodynamic Therapy||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Small Clinical Study: Photodynamic Therapy to Treat Hidradenitis Suppurativa|
|Study Start Date :||October 2006|
|Actual Study Completion Date :||September 2007|
- Active and inactive lesion count [ Time Frame: 0,1,2,3,4,8,16 weeks ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00395187
|United States, Kansas|
|University of Kansas Medical Center|
|Kansas City, Kansas, United States, 66160|
|Principal Investigator:||Daniel Aires, MD||University of Kansas Medical Center|