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A Small Clinical Study: Photodynamic Therapy to Treat Hidradenitis Suppurativa
This study has been completed.
Study NCT00395187   Information provided by University of Kansas
First Received: November 1, 2006   Last Updated: October 4, 2007   History of Changes

November 1, 2006
October 4, 2007
October 2006
 
Active and inactive lesion count [ Time Frame: 0,1,2,3,4,8,16 weeks ]
Active and inactive lesion count
Complete list of historical versions of study NCT00395187 on ClinicalTrials.gov Archive Site
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 ]
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.
 
A Small Clinical Study: Photodynamic Therapy to Treat Hidradenitis Suppurativa
A Small Clinical Study: Photodynamic Therapy to Treat Hidradenitis Suppurativa

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.

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.

 
Interventional
Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Hidradenitis Suppurativa
Procedure: Photodynamic Therapy
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
15
September 2007
 

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Pregnancy/lactation
  • photosensitizing drug use within 30 days of start of study
  • active infection needing antibiotics
  • history of porphyria or photosensitivity
Both
18 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00395187
 
10514
University of Kansas
DUSA Pharmaceuticals, Inc.
Principal Investigator: Daniel Aires, MD University of Kansas
University of Kansas
October 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP