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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.
Last refreshed on: 25 May 2015
Main ID:  NCT01110642
Date of registration: 22/04/2010
Prospective Registration: Yes
Primary sponsor: Northwestern University
Public title: Novel Treatment for Syndromic Ichthyoses
Scientific title: Open-label, Pilot Study to Assess Cholesterol-Lovastatin Solution in the Treatment of Syndromic Ichthyoses
Date of first enrolment: July 2011
Target sample size: 0
Recruitment status: Withdrawn
Study type:  Interventional
Study design:  Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment  
Phase:  Phase 2
Countries of recruitment
United States
Name:     Amy S Paller, MD
Affiliation:  Northwestern University
Key inclusion & exclusion criteria

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
Health Condition(s) or Problem(s) studied
CHILD Syndrome
Conradi Syndrome
Smith Lemli Opitz Syndrome
Syndromic Ichthyoses
Drug: Lovastatin
Primary Outcome(s)
Physician global assessment of severity (PGAS) [Time Frame: 12 months]
Secondary Outcome(s)
Total body surface area (TBSA) [Time Frame: 12 months]
Secondary ID(s)
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results available:
Date Posted:
Date Completed:
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