A Small Clinical Study: Photodynamic Therapy to Treat Hidradenitis Suppurativa
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Hidradenitis Suppurativa |
Procedure: Photodynamic Therapy |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Small Clinical Study: Photodynamic Therapy to Treat Hidradenitis Suppurativa |
- Active and inactive lesion count [ Time Frame: 0,1,2,3,4,8,16 weeks ]
- 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 ]
| Estimated Enrollment: | 15 |
| Study Start Date: | October 2006 |
| Study Completion Date: | September 2007 |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts 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
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00395187
| United States, Kansas | |
| University of Kansas Medical Center | |
| Kansas City, Kansas, United States, 66160 | |
| Principal Investigator: | Daniel Aires, MD | University of Kansas |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00395187 History of Changes |
| Other Study ID Numbers: | 10514 |
| Study First Received: | November 1, 2006 |
| Last Updated: | October 4, 2007 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Hidradenitis Hidradenitis Suppurativa Bacterial Infections Infection Skin Diseases |
Skin Diseases, Bacterial Skin Diseases, Infectious Suppuration Sweat Gland Diseases |
ClinicalTrials.gov processed this record on March 03, 2015