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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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25 May 2015 |
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Main ID: |
NCT01110642 |
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Date of registration:
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22/04/2010 |
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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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Novel Treatment for Syndromic Ichthyoses
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Scientific title:
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Open-label, Pilot Study to Assess Cholesterol-Lovastatin Solution in the Treatment of Syndromic Ichthyoses |
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Date of first enrolment:
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July 2011 |
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Target sample size:
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0 |
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Recruitment status: |
Withdrawn |
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URL:
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http://clinicaltrials.gov/show/NCT01110642 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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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:
- Informed Consent form signed by the subject or subject's legal representative; also,
if the subject is under the age of majority but capable of providing assent, signed
assent from the subject.
- Diagnosis of a syndromic ichthyoses (verified by Dr Amy S. Paller).
- Children and adults 12 months of age and above
Exclusion Criteria:
- Use of any investigational drug within the 30 days before enrollment.
- Current malignancy.
- Pregnancy or breastfeeding during the study. (All female subjects of childbearing
potential will be assessed for pregnancy at all visits.)
Age minimum:
1 Year
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Conradi Syndrome
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Syndromic Ichthyoses
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CHILD Syndrome
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Smith Lemli Opitz Syndrome
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Intervention(s)
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Drug: Lovastatin
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Primary Outcome(s)
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Physician global assessment of severity (PGAS)
[Time Frame: 12 months]
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Secondary Outcome(s)
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Total body surface area (TBSA)
[Time Frame: 12 months]
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Secondary ID(s)
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2010-04-15
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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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