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Efficacy and Safety Study of CD 2027 Spray in Subjects With Plaque-type Psoriasis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00763555
Recruitment Status : Completed
First Posted : October 1, 2008
Last Update Posted : January 11, 2012
Information provided by (Responsible Party):

Brief Summary:
This is a multicenter, randomized, vehicle-controlled, double-blind parallel group study to evaluate the efficacy and safety of CD 2027 Oily Spray applied twice daily for 8 weeks in subjects with plaque-type psoriasis.

Condition or disease Intervention/treatment Phase
Psoriasis Drug: CD 2027 Drug: Vehicle (placebo) Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Vehicle-controlled, Efficacy and Safety Study of CD2027 3µg/g Oily Spray Applied Twice Daily for 8 Weeks in Subjects With Plaque-type Psoriasis
Study Start Date : September 2008
Actual Primary Completion Date : January 2009
Actual Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis
Drug Information available for: Calcitriol

Arm Intervention/treatment
Experimental: 1
CD 2027, 3 ug/g Oily Spray, twice a day for 8 weeks
Drug: CD 2027
3 µg/g Oily Spray, twice a day for 8 weeks
Other Name: Calcitriol

Placebo Comparator: 2 Drug: Vehicle (placebo)
placebo spray, twice a day for 8 weeks

Primary Outcome Measures :
  1. Success rates at Week 8 [ Time Frame: Screening, Baseline and Week 2, 4 , 6 , and 8 visits ]

Secondary Outcome Measures :
  1. Change in Global Severity Score from Baseline at Week 8 [ Time Frame: Screening, Baseline and Week 2, 4 , 6 , and 8 visits ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Subject has a diagnosis of plaque-type psoriasis up to 20% of body surface area (BSA) involved excluding the scalp, with a Global Severity Score of at least 3 (moderate) at Screening
  • Subject presents with a representative target lesion that is at least 16 cm² in area, is located on the non-bony areas of the skin, has a Scaling Score up to 2 (moderate), has a DSS of at least 4

Exclusion Criteria:

  • Other type of psoriasis (other than plaque)
  • Significant abnormal lab findings
  • 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 identifier (NCT number): NCT00763555

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United States, Minnesota
Minnesota Clinical Study Center
Fridley, Minnesota, United States, 55432
United States, Tennessee
Tennessee Clinical Research Center
Nashville, Tennessee, United States, 37215
Canada, Alberta
Stratica Medical
Edmonton, Alberta, Canada, T5K1X3
Canada, Ontario
Ultranova Skincare
Barrie, Ontario, Canada, L4M6L2
North Bay Dermatology Centre
North Bay, Ontario, Canada, P1B3Z7
K. Papp Clinical Research, Inc.
Waterloo, Ontario, Canada, N2J1C4
Sponsors and Collaborators
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Responsible Party: Galderma Identifier: NCT00763555    
Other Study ID Numbers: RD.06.SPR.18119
First Posted: October 1, 2008    Key Record Dates
Last Update Posted: January 11, 2012
Last Verified: January 2012
Keywords provided by Galderma:
Additional relevant MeSH terms:
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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
Growth Substances
Bone Density Conservation Agents