Pharmacokinetic (PK) and Pharmacodynamic (PD) Study of CD 2027 Spray in Adults With Plaque-type Psoriasis

• Status: Completed
• Trial end date: 2009-02-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a multicenter, open-label study to assess systemic plasma levels of calcitriol, calcium homeostasis and safety in adults with plaque-type psoriasis under conditions of maximized use of CD 2027 3µg/g oily spray twice daily (6 g daily), applied to 20% of BSA for 3 weeks.

There are a total of six visits: Pre-treatment period (Day -15, Day -8 and Day -1) and Treatment period (Day 1/ Baseline, Day 15 and Day 22).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Galderma; Galderma R&D
• Treatments: Calcitriol

Criteria

Inclusion Criteria:

• Diagnosis of plaque-type psoriasis involving 10% - 20% of body surface area (BSA), with a Global Severity Score of at least 3 (moderate)

Exclusion Criteria:

• Other type of psoriasis (other than plaque)

• Significant abnormal lab findings

• Secondary hyperparathyroidism

• Vit D deficiency

• Hypercalcemia