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Efficacy, Safety, Preference and Response Duration of Clobex® Spray and Taclonex® Ointment in Psoriasis

This study has been completed.
Sponsor:
Information provided by:
Galderma Laboratories, L.P.
ClinicalTrials.gov Identifier:
NCT00437255
First received: February 16, 2007
Last updated: April 3, 2008
Last verified: April 2008
History of Changes
  Purpose

Evaluate the efficacy of Clobex® Spray as compared to Taclonex® Ointment in terms of Overall Disease Severity and Investigator Global Assessment.


Condition Intervention Phase
Plaque Psoriasis
 Drug: Clobetasol Propionate, 0.05%
Drug: Calcipotriene and betamethasone dipropionate ointment
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: An Evaluation of the Efficacy, Safety, Preference and Duration of Response of Clobex® (Clobetasol Propionate) Spray and Taclonex® (Calcipotriene 0.05%/Betamethasone Dipropionate 0.064%) Ointment in Subjects With Stable Plaque Psoriasis

Resource links provided by NLM:

MedlinePlus related topics: Psoriasis
U.S. FDA Resources

Further study details as provided by Galderma Laboratories, L.P.:

Primary Outcome Measures:
  • Overall Disease Severity [ Time Frame: End of treatment (Week 4) ] [ Designated as safety issue: No ]
  • Tolerability assessments, incidence of adverse events [ Time Frame: Baseline, Weeks 1, 2, 4 and 8 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Overall Disease Severity [ Time Frame: Weeks 1, 2 and 8 ] [ Designated as safety issue: No ]
  • Investigator Global Assessment [ Time Frame: End of treatment (week 4) and Weeks 1, 2 and 8 ] [ Designated as safety issue: No ]

Enrollment: 122
Study Start Date: August 2006
Study Completion Date: June 2007
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Clobex® Spray
 Drug: Clobetasol Propionate, 0.05%
Topical, twice daily for 4 weeks
Other Name: Clobex® Spray
Active Comparator: 2
Taclonex® Ointment
 Drug: Calcipotriene and betamethasone dipropionate ointment
Topical, once daily
Other Name: Taclonex® Ointment

Detailed Description:

Same as above.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Moderate to severe psoriasis involving 3-20% of the body surface area

Exclusion Criteria:

  • Subjects who have surface area involvement too large that would require more than 50 grams per week of Clobex® Spray or more than 100 grams per week of Taclonex® Ointment
  • Subjects having psoriasis that involves the scalp, face, or groin
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00437255

Locations
United States, Minnesota
Minnesota Clinical Study Center
Fridley, Minnesota, United States, 55432
United States, Texas
DermResearch, Inc.
Austin, Texas, United States, 78759
J & S Studies, Inc.
Bryan, Texas, United States, 77802
Baylor Research Institute
Dallas, Texas, United States, 75230
Sponsors and Collaborators
Galderma Laboratories, L.P.
Investigators
Study Director: Ronald W Gottschalk, MD Galderma Laboratories, LP
  More Information

No publications provided

Responsible Party: Ronald W. Gottschalk, MD / Medical Director, Galderma Laboratories, L.P.
ClinicalTrials.gov Identifier: NCT00437255     History of Changes
Other Study ID Numbers: US10034
Study First Received: February 16, 2007
Last Updated: April 3, 2008
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Betamethasone-17,21-dipropionate
Betamethasone
Clobetasol
Betamethasone sodium phosphate
Calcipotriene
Calcitriol
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
 Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Dermatologic Agents
Vitamins
Micronutrients
Growth Substances
Bone Density Conservation Agents
Calcium Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasoconstrictor Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 23, 2013