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Novel Treatment for Syndromic Ichthyoses

This study has been withdrawn prior to enrollment.
(Study was withdrawn due to lack of eligible population for study)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01110642
First Posted: April 26, 2010
Last Update Posted: May 19, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Amy Paller, Northwestern University
  Purpose
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.

Condition Intervention Phase
Syndromic Ichthyoses CHILD Syndrome Smith Lemli Opitz Syndrome Conradi Syndrome Drug: Lovastatin Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-label, Pilot Study to Assess Cholesterol-Lovastatin Solution in the Treatment of Syndromic Ichthyoses

Resource links provided by NLM:


Further study details as provided by Amy Paller, Northwestern University:

Primary Outcome Measures:
  • Physician global assessment of severity (PGAS) [ Time Frame: 12 months ]
    Difference in physician global assessment of severity at baseline compared to month 12


Secondary Outcome Measures:
  • Total body surface area (TBSA) [ Time Frame: 12 months ]
    Percent change in TBSA affected at baseline compared to at month 12


Enrollment: 0
Study Start Date: July 2011
Arms Assigned Interventions
Experimental: Lovastatin solution
All patients will receive lovastatin solution
Drug: Lovastatin
Topical lovastatin applied to red, rashy areas two times daily for 12 months

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   1 Year and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01110642


Sponsors and Collaborators
Northwestern University
Investigators
Principal Investigator: Amy S Paller, MD Northwestern University
  More Information

Responsible Party: Amy Paller, Professor and Chair of Department of Dermatology, Professor of Pediatrics, Northwestern University
ClinicalTrials.gov Identifier: NCT01110642     History of Changes
Other Study ID Numbers: 2010-04-15
First Submitted: April 22, 2010
First Posted: April 26, 2010
Last Update Posted: May 19, 2015
Last Verified: May 2015

Additional relevant MeSH terms:
Ichthyosiform Erythroderma, Congenital
Syndrome
Ichthyosis
Ichthyosis, Lamellar
Smith-Lemli-Opitz Syndrome
Disease
Pathologic Processes
Skin Abnormalities
Congenital Abnormalities
Infant, Newborn, Diseases
Keratosis
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Abnormalities, Multiple
Lipid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Steroid Metabolism, Inborn Errors
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Lovastatin
L 647318
Dihydromevinolin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors