Novel Treatment for Syndromic Ichthyoses

NCT ID: NCT01110642

Last Updated: 2015-05-19

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-31

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.

Conditions

Syndromic Ichthyoses; CHILD Syndrome; Smith Lemli Opitz Syndrome; Conradi Syndrome

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Lovastatin solution

All patients will receive lovastatin solution

Group Type: EXPERIMENTAL

Lovastatin

Intervention Type: DRUG

Topical lovastatin applied to red, rashy areas two times daily for 12 months

Interventions

Lovastatin

Topical lovastatin applied to red, rashy areas two times daily for 12 months

Intervention Type: DRUG

Eligibility 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.)

• Minimum Eligible Age: 1 Year
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Amy Paller

Professor and Chair of Department of Dermatology, Professor of Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Amy S Paller, MD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Other Identifiers

2010-04-15

Identifier Type: -

Identifier Source: org_study_id