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

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ClinicalTrials.gov Identifier: NCT00763503
Recruitment Status : Completed
First Posted : October 1, 2008
Last Update Posted : January 11, 2012
Sponsor:
Information provided by (Responsible Party):
Galderma

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).


Condition or disease Intervention/treatment Phase
Plaque-type Psoriasis Drug: CD 2027 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : September 2008
Actual Primary Completion Date : December 2008
Actual Study Completion Date : February 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis
Drug Information available for: Calcitriol

Arm Intervention/treatment
Experimental: CD 2027 Drug: CD 2027
3µg/g Oily Spray
Other Name: Calcitriol




Primary Outcome Measures :
  1. CD 2027 plasma concentrations [ Time Frame: 0, 1, 2, 3, 4, 6, 9, 12 hour time points ]

Secondary Outcome Measures :
  1. Calcium homeostasis [ Time Frame: Screening, Day -8, -1 and prior to the morning application on Day 1, 15 and 22 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00763503


Locations
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United States, Arizona
Burke Pharmaceutical Research
Hot Springs, Arizona, United States, 71913
United States, Texas
DermResearch
Austin, Texas, United States, 78759
J & S Studies
Bryan, Texas, United States, 77845
Sponsors and Collaborators
Galderma

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Responsible Party: Galderma
ClinicalTrials.gov Identifier: NCT00763503     History of Changes
Other Study ID Numbers: RD.06.SPR.18118
First Posted: October 1, 2008    Key Record Dates
Last Update Posted: January 11, 2012
Last Verified: January 2012
Keywords provided by Galderma:
psoriasis
PK
calcitriol
Additional relevant MeSH terms:
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Calcitriol
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Calcium Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasoconstrictor Agents
Vitamins
Micronutrients
Nutrients
Growth Substances
Bone Density Conservation Agents