A Small Clinical Study: Photodynamic Therapy to Treat Hidradenitis Suppurativa - Tabular View

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A Small Clinical Study: Photodynamic Therapy to Treat Hidradenitis Suppurativa

This study has been completed.
Information provided by University of Kansas

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

A Small Clinical Study: Photodynamic Therapy to Treat Hidradenitis Suppurativa

Official Title ^†

A Small Clinical Study: Photodynamic Therapy to Treat Hidradenitis Suppurativa

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.

Study Phase

Study Type ^†

Interventional

Study Design ^†

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study

Primary Outcome Measure ^†

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

Secondary Outcome Measure ^†

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 ]

Condition ^†

Hidradenitis Suppurativa

Intervention ^†

Procedure: Photodynamic Therapy

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Completed

Enrollment ^†

Start Date ^†

October 2006

Completion Date

September 2007

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

Gender

Both

Ages

18 Years to 55 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Administrative Information Fields

NCT ID ^†

NCT00395187

Organization ID

10514

Secondary IDs ^††

Study Sponsor ^†

University of Kansas

Collaborators ^††

DUSA Pharmaceuticals, Inc.

Investigators ^†

Principal Investigator:

Daniel Aires, MD

University of Kansas

Information Provided By

University of Kansas

Verification Date

October 2007

First Received Date ^†

November 1, 2006

Last Updated Date

October 4, 2007

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.