Ignite Creation Date:
2024-05-05 @ 10:01 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004690
Status:
COMPLETED
Last Update Posted:
2015-03-25
First Post:
2000-02-24
Brief Title:
Phase III Study of Monolaurin Cream Therapy for Patients With Congenital Ichthyosis
Sponsor:
Cellegy Pharmaceuticals
Organization:
FDA Office of Orphan Products Development
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
1999-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CELLEGY-FDR001278 | None | None | None |