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| Sponsors and Collaborators: |
FDA Office of Orphan Products Development Cellegy Pharmaceuticals |
| Information provided by: | FDA Office of Orphan Products Development |
| ClinicalTrials.gov Identifier: | NCT00004690 |
Purpose
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.
| Condition | Intervention | Phase |
|
Ichthyosis |
Drug: monolaurin cream |
Phase III |
| Drug Information available for: | Monolaurin |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Safety/Efficacy Study |
| Estimated Enrollment: | 90 |
| Study Start Date: | September 1996 |
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.
Eligibility
| Ages Eligible for Study: | 2 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
--Prior/Concurrent Therapy--
--Patient Characteristics--
Contacts and Locations| FDA Office of Orphan Products Development |
| Cellegy Pharmaceuticals |
| Study Chair: | Carl R. Thornfeldt | Cellegy Pharmaceuticals |
More Information
| Study ID Numbers: | 199/13316, CELLEGY-FDR001278 |
| First Received: | February 24, 2000 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00004690 |
| Health Authority: | United States: Federal Government |
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