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

This study has been completed.
Information provided by (Responsible Party):
Galderma Identifier:
First received: September 30, 2008
Last updated: January 6, 2012
Last verified: January 2012
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 Intervention Phase
Psoriasis Drug: CD 2027 Drug: Vehicle (placebo) Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Galderma:

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

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

Enrollment: 88
Study Start Date: September 2008
Study Completion Date: March 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00763555

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
  More Information

Responsible Party: Galderma Identifier: NCT00763555     History of Changes
Other Study ID Numbers: RD.06.SPR.18119
Study First Received: September 30, 2008
Last Updated: January 6, 2012

Keywords provided by Galderma:

Additional relevant MeSH terms:
Skin Diseases, Papulosquamous
Skin Diseases
Calcium Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasoconstrictor Agents
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents processed this record on September 25, 2017