A Small Clinical Study: Photodynamic Therapy to Treat Hidradenitis Suppurativa
- Conditions
- Hidradenitis Suppurativa
- Registration Number
- NCT00395187
- Lead Sponsor
- University of Kansas
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 15
- multiple lesions consistent with HS in axillae/groin
- history of no or poor response to at least one treatment modality
- no active treatment in the 2 weeks prior to study initiation
- Pregnancy/lactation
- photosensitizing drug use within 30 days of start of study
- active infection needing antibiotics
- history of porphyria or photosensitivity
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Active and inactive lesion count 0,1,2,3,4,8,16 weeks
- Secondary Outcome Measures
Name Time Method 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. 0,1,2,3,4,8,16 weeks
Trial Locations
- Locations (1)
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States