Ignite Creation Date:
2024-05-05 @ 5:14 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00419666
Status:
COMPLETED
Last Update Posted:
2021-02-18
First Post:
2007-01-05
Brief Title:
A Study of Calcitriol BID Topical Treatment in Adolescents With Plaque Psoriasis
Sponsor:
Galderma RD
Organization:
Galderma RD
Study Overview
Official Title:
PK and PD of Calcitriol Following Twice Daily Application of Calcitriol 3 µgg Ointment Under Conditions of Maximal Use in Adolescents With Plaque Psoriasis
Status:
COMPLETED
Status Verified Date:
2019-11
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:
This is an open-label multicenter study to assess the systemic exposure to calcitriol in the adolescent population Calcitriol 3µgg ointment 2 mgcm² per application is to be applied twice daily to involved skin 10 - 35 BSA involved excluding face scalp and intertriginous areas for 56 days 8 weeks Full Pharmacokinetic PK and Pharmacodynamic PD profile will be collected during the first 3 weeks of the study safety and efficacy data will be collected for the 8 weeks of the treatment
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None