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A Small Clinical Study: Photodynamic Therapy to Treat Hidradenitis Suppurativa

This study has been completed.

Sponsors and Collaborators: University of Kansas
DUSA Pharmaceuticals
Information provided by: University of Kansas
ClinicalTrials.gov Identifier: NCT00395187
  Purpose

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.


Condition Intervention
Hidradenitis Suppurativa
Procedure: Photodynamic Therapy

MedlinePlus related topics:   Hidradenitis Suppurativa  

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:   A Small Clinical Study: Photodynamic Therapy to Treat Hidradenitis Suppurativa

Further study details as provided by University of Kansas:

Primary Outcome Measures:
  • Active and inactive lesion count [ Time Frame: 0,1,2,3,4,8,16 weeks ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment:   15
Study Start Date:   October 2006
Study Completion Date:   September 2007

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.

  Eligibility
Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00395187

Locations
United States, Kansas
University of Kansas Medical Center    
      Kansas City, Kansas, United States, 66160

Sponsors and Collaborators
University of Kansas
DUSA Pharmaceuticals

Investigators
Principal Investigator:     Daniel Aires, MD     University of Kansas    
  More Information

Study ID Numbers:   10514
First Received:   November 1, 2006
Last Updated:   October 4, 2007
ClinicalTrials.gov Identifier:   NCT00395187
Health Authority:   United States: Institutional Review Board

Study placed in the following topic categories:
Bacterial Infections
Mycoses
Communicable Diseases
Skin Diseases, Infectious
Skin Diseases
Skin Diseases, Bacterial
Connective Tissue Diseases
Suppuration
Hidradenitis
Infection
Hidradenitis suppurativa
Hidradenitis Suppurativa

Additional relevant MeSH terms:
Skin and Connective Tissue Diseases
Bacterial Infections and Mycoses
Sweat Gland Diseases

ClinicalTrials.gov processed this record on May 08, 2008