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

Phase 3

Completed

• Conditions: Ichthyosis

• Registration Number: NCT00004690
• Lead Sponsor: Cellegy Pharmaceuticals

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 Description

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

Study Timeline

• Study Start: 1996-09
• Study Completion: 1998-09
• Status Verified: 1999-03
• Study First Submitted: 2000-02-24
• Study First Submitted QC: 2000-02-24
• Study First Posted: 2000-02-25
• Last Update Submitted: 2015-03-24
• Last Update Posted: 2015-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified