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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00395187 |
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Date of registration:
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01/11/2006 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A Small Clinical Study: Photodynamic Therapy to Treat Hidradenitis Suppurativa
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Scientific title:
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A Small Clinical Study: Photodynamic Therapy to Treat Hidradenitis Suppurativa |
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Date of first enrolment:
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October 2006 |
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Target sample size:
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15 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00395187 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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N/A
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Countries of recruitment
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United States
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Contacts
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Name:
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Daniel Aires, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Kansas |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
55 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Hidradenitis Suppurativa
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Intervention(s)
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Procedure: Photodynamic Therapy
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Primary Outcome(s)
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Active and inactive lesion count
[Time Frame: 0,1,2,3,4,8,16 weeks]
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Secondary Outcome(s)
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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]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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