Clinical Trial: Novel Treatment for Syndromic Ichthyoses

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

Official Title: 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 Summary:
Sponsor: Northwestern University

Current Primary Outcome: 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: Physician global assessment (PGAS) [ Time Frame: 12 months ]

Difference in physician global assessment of severity at baseline compared to month 12


Current Secondary Outcome: Total body surface area (TBSA) [ Time Frame: 12 months ]

Percent change in TBSA affected at baseline compared to at month 12


Original Secondary Outcome: BSA [ Time Frame: 12 months ]

Percent change in TBSA affected at baseline compared to at month 12


Information By: Northwestern University

Dates:
Date Received: April 22, 2010
Date Started: July 2011
Date Completion:
Last Updated: May 15, 2015
Last Verified: May 2015