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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Galderma
ClinicalTrials.gov Identifier:
NCT00763555
First received: September 30, 2008
Last updated: January 6, 2012
Last verified: January 2012
History of Changes
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

MedlinePlus related topics: Psoriasis
Drug Information available for: Calcitriol
U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

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

  Eligibility

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

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00763555

Locations
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
Galderma
  More Information

No publications provided

Responsible Party: Galderma
ClinicalTrials.gov Identifier: NCT00763555     History of Changes
Other Study ID Numbers: RD.06.SPR.18119
Study First Received: September 30, 2008
Last Updated: January 6, 2012
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by Galderma:
psoriasis
spray
calcitriol

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Calcitriol
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
 Pharmacologic Actions
Bone Density Conservation Agents
Calcium Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013