Hidradenitis Suppurativa
Conditions
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.
Interventions
PROCEDUREPhotodynamic Therapy
Sponsors
DUSA Pharmaceuticals, Inc.
University of Kansas
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Active and inactive lesion count | 0,1,2,3,4,8,16 weeks |
Secondary
| Measure | Time frame |
|---|---|
| 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. | 0,1,2,3,4,8,16 weeks |
Countries
United States
Outcome results
None listed