Plaque-type Psoriasis Clinical Trial
Official title:
Pharmacokinetic and Pharmacodynamic Study of CD 2027 3µg/g Oily Spray Applied Twice Daily for 3 Weeks Under Conditions of Maximized Use in Adults With Plaque-type Psoriasis
| Verified date | January 2012 |
| Source | Galderma R&D |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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).
| Status | Completed |
| Enrollment | 26 |
| Est. completion date | February 2009 |
| Est. primary completion date | December 2008 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | DermResearch | Austin | Texas |
| United States | J & S Studies | Bryan | Texas |
| United States | Burke Pharmaceutical Research | Hot Springs | Arizona |
| Lead Sponsor | Collaborator |
|---|---|
| Galderma R&D |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | CD 2027 plasma concentrations | 0, 1, 2, 3, 4, 6, 9, 12 hour time points | ||
| Secondary | Calcium homeostasis | Screening, Day -8, -1 and prior to the morning application on Day 1, 15 and 22 |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Withdrawn |
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