drugset / Trial / NCT00419666

A Study of Calcitriol BID Topical Treatment in Adolescents With Plaque Psoriasis

NCT00419666

Phase 2 Completed 25 enrolled Galderma R&D
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2006-08-01
Primary completion
2009-09-24
Completion
2009-09-24

Drugs

EvaluationDrugModalityDoseRoute
Subject Calcitriol Small molecule 3 unknown Topical

Indications