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Novel Treatment for Syndromic Ichthyoses

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ClinicalTrials.gov Identifier: NCT01110642
Recruitment Status : Withdrawn (Study was withdrawn due to lack of eligible population for study)
First Posted : April 26, 2010
Last Update Posted : May 19, 2015
Sponsor:
Information provided by (Responsible Party):
Amy Paller, Northwestern University

Tracking Information
First Submitted Date  ICMJE April 22, 2010
First Posted Date  ICMJE April 26, 2010
Last Update Posted Date May 19, 2015
Study Start Date  ICMJE July 2011
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: April 26, 2010)
Physician global assessment of severity (PGAS) [ Time Frame: 12 months ]
Difference in physician global assessment of severity at baseline compared to month 12
Original Primary Outcome Measures  ICMJE
 (submitted: April 23, 2010)
Physician global assessment (PGAS) [ Time Frame: 12 months ]
Difference in physician global assessment of severity at baseline compared to month 12
Change History Complete list of historical versions of study NCT01110642 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 26, 2010)
Total body surface area (TBSA) [ Time Frame: 12 months ]
Percent change in TBSA affected at baseline compared to at month 12
Original Secondary Outcome Measures  ICMJE
 (submitted: April 23, 2010)
BSA [ Time Frame: 12 months ]
Percent change in TBSA affected at baseline compared to at month 12
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Novel Treatment for Syndromic Ichthyoses
Official Title  ICMJE Open-label, Pilot Study to Assess Cholesterol-Lovastatin Solution in the Treatment of Syndromic Ichthyoses
Brief Summary This is an open label-pilot study to assess the efficacy and safety of a novel cholesterol-lovastatin topical solution in children with rare syndromic ichthyoses. Often times, these children have difficulty in finding easily applied treatments to make their psoriasiform and ichthyotic plaques more manageable. We propose the use of a cholesterol-lovastatin topical solution as a treatment option with the hypothesis that it will lead to regression of involved areas and decreased erythema and warty-like appearance of the plaques. We plan to enroll children with syndromic ichthyoses over the age of 1 year for a 12 month study with a total of 5 visits and 5 phone calls.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Syndromic Ichthyoses
  • CHILD Syndrome
  • Smith Lemli Opitz Syndrome
  • Conradi Syndrome
Intervention  ICMJE Drug: Lovastatin
Topical lovastatin applied to red, rashy areas two times daily for 12 months
Study Arms  ICMJE Experimental: Lovastatin solution
All patients will receive lovastatin solution
Intervention: Drug: Lovastatin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: November 29, 2012)
0
Original Estimated Enrollment  ICMJE
 (submitted: April 23, 2010)
15
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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.)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Year and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT01110642
Other Study ID Numbers  ICMJE 2010-04-15
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Amy Paller, Northwestern University
Study Sponsor  ICMJE Northwestern University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Amy S Paller, MD Northwestern University
PRS Account Northwestern University
Verification Date May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP