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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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12 December 2020 |
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Main ID: |
NCT00825565 |
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Date of registration:
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19/01/2009 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Study of Alwextin® Cream in Treating Epidermolysis Bullosa
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Scientific title:
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Open-label, Pilot Study to Investigate the Safety and Tolerability of Alwextin 3.0% Cream in the Treatment of Epidermolysis Bullosa |
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Date of first enrolment:
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February 2009 |
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Target sample size:
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8 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00825565 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 2
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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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Amy S Paller, 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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Northwestern University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- history of epidermolysis bullosa
Exclusion Criteria:
- use of any skin product containing allantoin for 30 days prior to enrollment
Age minimum:
6 Months
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Epidermolysis Bullosa
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Intervention(s)
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Drug: Alwextin cream
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Primary Outcome(s)
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Physician Assessment of Individual Signs
[Time Frame: baseline and at 12 weeks]
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Blister/Erosion Reduction Based on Change in Body Surface Area (BSA) Coverage
[Time Frame: baseline and then every 4 weeks for a total of 12 weeks]
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Physician Global Assessment of Severity (PGAS)
[Time Frame: baseline and then every 4 weeks for a total of 12 weeks]
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Target Wound Size Reduction or Closure
[Time Frame: baseline and then every 4 weeks for a total of 12 weeks]
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Secondary ID(s)
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Alwextin 3.0%-04
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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