Novel Treatment for Syndromic Ichthyoses

Open-label, Pilot Study to Assess Cholesterol-Lovastatin Solution in the Treatment of Syndromic Ichthyoses

Status

Withdrawn

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01110642

Enrollment

Registered

2010-04-26

Start date

2011-07-31

Completion date

Unknown

Last updated

2015-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

CHILD Syndrome, Conradi Syndrome, Smith Lemli Opitz Syndrome, 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.

Interventions

DRUGLovastatin

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

1 Years to No maximum

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.)

Design outcomes

Primary

Measure	Time frame	Description
Physician global assessment of severity (PGAS)	12 months	Difference in physician global assessment of severity at baseline compared to month 12

Secondary

Measure	Time frame	Description
Total body surface area (TBSA)	12 months	Percent change in TBSA affected at baseline compared to at month 12

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026