Clinical Trial: Phase III Study of Monolaurin Cream Therapy for Patients With Congenital Ichthyosis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title:

Brief Summary:

OBJECTIVES: I. Compare the safety and efficacy of monolaurin cream versus a placebo vehicle cream in suppressing the signs of nonbullous congenital ichthyosiform erythroderma.

II. Assess the incidence of posttreatment rebound or recrudescence in patients with congenital ichthyosis.

III. Evaluate the long term safety of monolaurin cream with whole body application in these patients.

Detailed Summary:

PROTOCOL OUTLINE: This is a three month, randomized, double blind, placebo controlled study followed by a nine month, open label, rollover study.

Patients are treated either with a placebo vehicle cream or the study cream, monolaurin (15% glyceryl monolaurate), for 3 months followed by a four week break. Medications are applied uniformly twice daily (morning and at least 1 hour before bedtime). After this blinded portion of the study, all patients are administered monolaurin cream for 9 months.

Patients are followed for 4 weeks after the last cream application.

Completion date provided represents the completion date of the grant per OOPD records

Sponsor: Cellegy Pharmaceuticals

Current Primary Outcome:

Original Primary Outcome:

Current Secondary Outcome:

Original Secondary Outcome:

Information By: FDA Office of Orphan Products Development

Dates:
Date Received: February 24, 2000
Date Started: September 1996
Date Completion: September 1998
Last Updated: March 24, 2015
Last Verified: March 1999