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Trial record 6 of 39 for:    Ichthyosis
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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This study has been withdrawn prior to enrollment.
(Study was withdrawn due to lack of eligible population for study)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:
Information provided by (Responsible Party):
Amy Paller, Northwestern University
ClinicalTrials.gov Identifier:
NCT01110642
First received: April 22, 2010
Last updated: November 29, 2012
Last verified: November 2012
History of Changes
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:

MedlinePlus related topics: Cholesterol
Drug Information available for: Lovastatin
U.S. FDA Resources

Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • Physician global assessment of severity (PGAS) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   1 Year and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01110642

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

No publications provided

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
Study First Received: April 22, 2010
Last Updated: November 29, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Ichthyosis
Ichthyosis, Lamellar
Smith-Lemli-Opitz Syndrome
Chondrodysplasia Punctata
Skin Abnormalities
Congenital Abnormalities
Infant, Newborn, Diseases
Keratosis
Skin Diseases
Ichthyosiform Erythroderma, Congenital
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
Osteochondrodysplasias
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Lovastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013