CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 25 enrolled
Drug / intervention
Calcitriol 3mcg/gdrug
Likely dose
Calcitriol 3mcg/gfrom record
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Search/NCT00419666
NCT00419666Phase 2Completed
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PK and PD of Calcitriol Following Twice Daily Application of Calcitriol 3 µg/g Ointment Under Conditions of Maximal Use in Adolescents With Plaque Psoriasis

Galderma R&D·interventional·Posted Jan 9, 2007·Updated Feb 18, 2021

In Brief

A Phase 2 clinical trial evaluating Calcitriol 3mcg/g for Chronic Plaque Psoriasis. Completed, enrolled 25 participants across 7 sites in 2 countries.

Detailed Summary

This is an open-label, multicenter study to assess the systemic exposure to calcitriol in the adolescent population. Calcitriol 3µg/g ointment (2 mg/cm² 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Plaque Psoriasis
CountriesCanada, United States
Collaborators--

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 9, 2007
Enrollment StartAug 1, 2006
Primary CompletionSep 24, 2009
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 19.5 years ago

Interventions

Calcitriol 3mcg/gdrug

Calcitriol 3mcg/g ointment applied twice daily for 56 weeks.