A Small Clinical Study: Photodynamic Therapy to Treat Hidradenitis Suppurativa

This study has been completed.
Sponsor:
Collaborator:
DUSA Pharmaceuticals, Inc.
Information provided by:
University of Kansas
ClinicalTrials.gov Identifier:
NCT00395187
First received: November 1, 2006
Last updated: October 4, 2007
Last verified: October 2007
  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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Small Clinical Study: Photodynamic Therapy to Treat Hidradenitis Suppurativa

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

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

Additional relevant MeSH terms:
Hidradenitis
Hidradenitis Suppurativa
Bacterial Infections
Infection
Skin Diseases
Skin Diseases, Bacterial
Skin Diseases, Infectious
Suppuration
Sweat Gland Diseases

ClinicalTrials.gov processed this record on October 23, 2014