NCT00419666

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Galderma R&D · Industry
• Sex: All
• Age: 12 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Plaque Psoriasis

Interventions

Type	Name	Description
DRUG	Calcitriol 3mcg/g	Calcitriol 3mcg/g ointment applied twice daily for 56 weeks.

Timeline

• Start date: 2006-08-01
• Primary completion: 2009-09-24
• Completion: 2009-09-24
• First posted: 2007-01-09
• Last updated: 2021-02-18
• Results posted: 2019-12-10

Locations

7 sites across 2 countries: United States, Canada