Pharmacokinetic (PK) and Pharmacodynamic (PD) Study of CD 2027 Spray in Adults With Plaque-Type Psoriasis - Full Text View

Sponsored by:	Galderma
Information provided by:	Galderma
ClinicalTrials.gov Identifier:	NCT00763503

Purpose

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).

Condition	Intervention	Phase
Plaque-Type Psoriasis	Drug: CD 2027	Phase II

MedlinePlus related topics: Calcium Psoriasis

Drug Information available for: Calcitriol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics/Dynamics Study
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

Further study details as provided by Galderma:

Primary Outcome Measures:

Calcitriol plasma concentrations [ Time Frame: 0, 1, 2, 3, 4, 6, 9, 12 hour time points ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Calcium homeostasis [ Time Frame: Screening, Day -8, -1 and prior to the morning application on Day 1, 15 and 22 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	24
Study Start Date:	September 2008
Estimated Study Completion Date:	February 2009
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
CD 2027: Experimental	Drug: CD 2027 3µg/g Oily Spray

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00763503

Contacts

Contact: Snezana Leitz, MD

609-860-8217

zana.leitz@galderma.com

Locations

United States, Arizona
Burke Pharmaceutical Research	Recruiting
Hot Springs, Arizona, United States, 71913
Contact: Tim Dugan 501-620-4449
Principal Investigator: Dowling Stough, MD
United States, Texas
DermResearch	Recruiting
Austin, Texas, United States, 78759
Contact: Martha Withers 512-349-9889
Principal Investigator: Michael Jarratt, MD
J & S Studies	Recruiting
Bryan, Texas, United States, 77845
Contact: Jeremy Scott 979-774-5933
Principal Investigator: Terry Jones, MD

Sponsors and Collaborators

Galderma

More Information

Responsible Party:	Head of US Development ( Michael Graeber, MD )
Study ID Numbers:	RD.06.SPR.18118
Study First Received:	September 29, 2008
Last Updated:	December 15, 2008
ClinicalTrials.gov Identifier:	NCT00763503
Health Authority:	United States: Food and Drug Administration; Canada: Health Canada

Keywords provided by Galderma:

psoriasis
PK
calcitriol

Study placed in the following topic categories:

Calcium, Dietary
Skin Diseases
Psoriasis
Skin Diseases, Papulosquamous
Calcitriol

Additional relevant MeSH terms:

Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Growth Substances
Vitamins
Calcium Channel Agonists

Physiological Effects of Drugs
Vasoconstrictor Agents
Bone Density Conservation Agents
Cardiovascular Agents
Micronutrients
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009