A Small Clinical Study: Photodynamic Therapy to Treat Hidradenitis Suppurativa
Primary Purpose
Hidradenitis Suppurativa
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Photodynamic Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Hidradenitis Suppurativa
Eligibility 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
Sites / Locations
- University of Kansas Medical Center
Outcomes
Primary Outcome Measures
Active and inactive lesion count
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.
Full Information
NCT ID
NCT00395187
First Posted
November 1, 2006
Last Updated
October 4, 2007
Sponsor
University of Kansas
Collaborators
DUSA Pharmaceuticals, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00395187
Brief Title
A Small Clinical Study: Photodynamic Therapy to Treat Hidradenitis Suppurativa
Official Title
A Small Clinical Study: Photodynamic Therapy to Treat Hidradenitis Suppurativa
Study Type
Interventional
2. Study Status
Record Verification Date
October 2007
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Kansas
Collaborators
DUSA Pharmaceuticals, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hidradenitis Suppurativa
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Photodynamic Therapy
Primary Outcome Measure Information:
Title
Active and inactive lesion count
Time Frame
0,1,2,3,4,8,16 weeks
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Aires, MD
Organizational Affiliation
University of Kansas Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
12. IPD Sharing Statement
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A Small Clinical Study: Photodynamic Therapy to Treat Hidradenitis Suppurativa
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