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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
University of Kansas
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hidradenitis Suppurativa

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

First Posted
November 1, 2006
Last Updated
October 4, 2007
Sponsor
University of Kansas
Collaborators
DUSA Pharmaceuticals, Inc.
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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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