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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00763503
• Other study ID #: RD.06.SPR.18118
• Status: Completed
• Phase: Phase 2
• Start date: September 2008
• Est. completion date: February 2009

Study information

• Verified date: January 2012
• Source: Galderma R&D
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Plaque-type Psoriasis
• Psoriasis

Intervention

Drug:
• CD 2027
3µg/g Oily Spray

Locations

Country	Name	City	State
United States	DermResearch	Austin	Texas
United States	J & S Studies	Bryan	Texas
United States	Burke Pharmaceutical Research	Hot Springs	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Galderma R&D

Country where clinical trial is conducted

United States, 

Outcome

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