Novel Treatment for Syndromic Ichthyoses

Northwestern University

Status and phase: Withdrawn; Phase 2

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

Treatments: Drug: Lovastatin

Study type: Interventional

Funder types: Other

Identifiers

NCT01110642

2010-04-15

Details and patient eligibility

About

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.

Sex: All

Ages: 1+ year old

Volunteers: No Healthy Volunteers

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.)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Lovastatin solution

Experimental group

Description:

All patients will receive lovastatin solution

Treatment:

Drug: Lovastatin