Pharmacokinetic (PK) and Pharmacodynamic (PD) Study of CD 2027 Spray in Adults With Plaque-type Psoriasis
- Registration Number
- NCT00763503
- Lead Sponsor
- Galderma R&D
- Brief 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 26
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description CD 2027 CD 2027 -
- Primary Outcome Measures
Name Time Method CD 2027 plasma concentrations 0, 1, 2, 3, 4, 6, 9, 12 hour time points
- Secondary Outcome Measures
Name Time Method Calcium homeostasis Screening, Day -8, -1 and prior to the morning application on Day 1, 15 and 22
Trial Locations
- Locations (3)
J & S Studies
🇺🇸Bryan, Texas, United States
Burke Pharmaceutical Research
🇺🇸Hot Springs, Arizona, United States
DermResearch
🇺🇸Austin, Texas, United States