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

• ClinicalTrials.gov Identifier: NCT00437255
• Recruitment Status: Completed
• First Posted: February 19, 2007
• Last Update Posted: April 7, 2008
• Sponsor: Galderma Laboratories, L.P.
• Information provided by: Galderma Laboratories, L.P.

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Plaque Psoriasis	Drug: Clobetasol Propionate, 0.05%; Drug: Calcipotriene and betamethasone dipropionate ointment	Phase 4

Detailed Description:

Same as above.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 122 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (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
• Study Start Date: August 2006
• Actual Primary Completion Date: June 2007
• Actual Study Completion Date: June 2007

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. Overall Disease Severity [ Time Frame: End of treatment (Week 4) ]
2. Tolerability assessments, incidence of adverse events [ Time Frame: Baseline, Weeks 1, 2, 4 and 8 ]

Secondary Outcome Measures :

1. Overall Disease Severity [ Time Frame: Weeks 1, 2 and 8 ]
2. Investigator Global Assessment [ Time Frame: End of treatment (week 4) and Weeks 1, 2 and 8 ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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

• Responsible Party: Ronald W. Gottschalk, MD / Medical Director, Galderma Laboratories, L.P.
• ClinicalTrials.gov Identifier: NCT00437255
• Other Study ID Numbers: US10034
• First Posted: February 19, 2007
• Last Update Posted: April 7, 2008
• Last Verified: April 2008

Additional relevant MeSH terms:

Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Betamethasone; Betamethasone Valerate; Betamethasone-17,21-dipropionate; Betamethasone benzoate; Clobetasol; Calcipotriene; Betamethasone sodium phosphate; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Anti-Asthmatic Agents; Respiratory System Agents; Dermatologic Agents