Back to resultsPharmacokinetic (PK) and Pharmacodynamic (PD) Study of CD 2027 Spray in Adults With Plaque-type Psoriasis
Primary Purpose
Plaque-type Psoriasis
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
CD 2027
Sponsored by
About this trial
This is an interventional treatment trial for Plaque-type Psoriasis focused on measuring psoriasis, PK, calcitriol
Eligibility 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
Sites / Locations
- Burke Pharmaceutical Research
- DermResearch
- J & S Studies
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CD 2027
Arm Description
Outcomes
Primary Outcome Measures
CD 2027 plasma concentrations
Secondary Outcome Measures
Calcium homeostasis
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00763503
Brief Title
Pharmacokinetic (PK) and Pharmacodynamic (PD) Study of CD 2027 Spray in Adults With Plaque-type Psoriasis
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
February 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Galderma R&D
4. Oversight
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plaque-type Psoriasis
Keywords
psoriasis, PK, calcitriol
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CD 2027
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
CD 2027
Other Intervention Name(s)
Calcitriol
Intervention Description
3µg/g Oily Spray
Primary Outcome Measure Information:
Title
CD 2027 plasma concentrations
Time Frame
0, 1, 2, 3, 4, 6, 9, 12 hour time points
Secondary Outcome Measure Information:
Title
Calcium homeostasis
Time Frame
Screening, Day -8, -1 and prior to the morning application on Day 1, 15 and 22
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Burke Pharmaceutical Research
City
Hot Springs
State/Province
Arizona
ZIP/Postal Code
71913
Country
United States
Facility Name
DermResearch
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
Country
United States
Facility Name
J & S Studies
City
Bryan
State/Province
Texas
ZIP/Postal Code
77845
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Pharmacokinetic (PK) and Pharmacodynamic (PD) Study of CD 2027 Spray in Adults With Plaque-type Psoriasis
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