A Small Clinical Study: Photodynamic Therapy to Treat Hidradenitis Suppurativa

NCT ID: NCT00395187

Last Updated: 2007-10-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-10-31
• Study Completion Date: 2007-09-30

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.

Conditions

Hidradenitis Suppurativa

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Photodynamic Therapy

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

DUSA Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: collaborator

University of Kansas

OTHER

Sponsor Role: lead

Principal Investigators

Daniel Aires, MD

Role: PRINCIPAL_INVESTIGATOR

University of Kansas Medical Center

Locations

University of Kansas Medical Center

Kansas City, Kansas, United States

Countries

United States

Other Identifiers

10514

Identifier Type: -

Identifier Source: org_study_id