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| Descriptive Information Fields | |||||
| Brief Title † | Phase III Study of Monolaurin Cream Therapy for Patients With Congenital Ichthyosis | ||||
| 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. |
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| 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. |
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| Study Phase | Phase III | ||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment, Randomized, Double-Blind, Placebo Control, Safety/Efficacy Study | ||||
| Primary Outcome Measure † | |||||
| Secondary Outcome Measure † | |||||
| Condition † | Ichthyosis | ||||
| Intervention † | Drug: monolaurin cream | ||||
| MEDLINE PMIDs | |||||
| Links | |||||
| Recruitment Information Fields | |||||
| Recruitment Status † | Active, not recruiting | ||||
| Enrollment † | 90 | ||||
| Start Date † | September 1996 | ||||
| Completion Date | |||||
| Eligibility Criteria † | PROTOCOL ENTRY CRITERIA: --Disease Characteristics--
--Prior/Concurrent Therapy--
--Patient Characteristics--
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| Gender | Both | ||||
| Ages | 2 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† | |||||
| Location Countries † | |||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00004690 | ||||
| Organization ID | 199/13316 | ||||
| Secondary IDs †† | CELLEGY-FDR001278 | ||||
| Study Sponsor † | FDA Office of Orphan Products Development | ||||
| Collaborators †† | Cellegy Pharmaceuticals | ||||
| Investigators † |
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| Information Provided By | FDA Office of Orphan Products Development | ||||
| Verification Date | March 1999 | ||||
| First Received Date † | February 24, 2000 | ||||
| Last Updated Date | June 23, 2005 | ||||