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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Recruitment Status : Withdrawn (Study was withdrawn due to lack of eligible population for study)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

April 22, 2010
April 26, 2010
May 19, 2015
July 2011
Not Provided
Physician global assessment of severity (PGAS) [ Time Frame: 12 months ]
Difference in physician global assessment of severity at baseline compared to month 12
Physician global assessment (PGAS) [ Time Frame: 12 months ]
Difference in physician global assessment of severity at baseline compared to month 12
Complete list of historical versions of study NCT01110642 on ClinicalTrials.gov Archive Site
Total body surface area (TBSA) [ Time Frame: 12 months ]
Percent change in TBSA affected at baseline compared to at month 12
BSA [ Time Frame: 12 months ]
Percent change in TBSA affected at baseline compared to at month 12
Not Provided
Not Provided
 
Novel Treatment for Syndromic Ichthyoses
Open-label, Pilot Study to Assess Cholesterol-Lovastatin Solution in the Treatment of Syndromic Ichthyoses
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.
Not Provided
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Syndromic Ichthyoses
  • CHILD Syndrome
  • Smith Lemli Opitz Syndrome
  • Conradi Syndrome
Drug: Lovastatin
Topical lovastatin applied to red, rashy areas two times daily for 12 months
Experimental: Lovastatin solution
All patients will receive lovastatin solution
Intervention: Drug: Lovastatin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
15
Not Provided
Not Provided

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.)
Sexes Eligible for Study: All
1 Year and older   (Child, Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
United States
 
NCT01110642
2010-04-15
No
Not Provided
Not Provided
Amy Paller, Northwestern University
Northwestern University
Not Provided
Principal Investigator: Amy S Paller, MD Northwestern University
Northwestern University
May 2015

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