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

Galderma R&D26 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Plaque-type Psoriasis

Interventions

CD 2027DRUG

3µg/g Oily Spray

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (3)

Burke Pharmaceutical Research

Hot Springs, Arizona, United States

DermResearch

Austin, Texas, United States

J & S Studies

Bryan, Texas, United States

Outcomes

Primary Outcomes

CD 2027 plasma concentrations

Time frame: 0, 1, 2, 3, 4, 6, 9, 12 hour time points

Secondary Outcomes

Calcium homeostasis

Time frame: Screening, Day -8, -1 and prior to the morning application on Day 1, 15 and 22

Data from ClinicalTrials.gov

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