Clinical trial NCT00658788: Safety & Effectiveness of Clobex Spray, Followed by Calcitriol Ointment in Management of Plaque Psoriasis
Official title: A Multi-Center, Open-Label Study to Evaluate the Safety and Efficacy of a Consecutive Treatment Regimen of Clobetasol Propionate 0.05% Spray, Followed by Calcitriol Ointment 3µg/g, in the Management of Moderate to Severe Plaque Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Psoriasis
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2008-04-15
Enrollment: 305
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objectives of this study are to evaluate the safety \& efficacy of consecutive treatments of Clobex® Spray and Silkis® Ointment in the management of plaque psoriasis.

Detailed description: Same as above.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of moderate to severe plaque psoriasis, defined as 3% - 20% treatable body surface area
* Overall Disease Severity of at least 3 (moderate)

Exclusion Criteria:

* Surface area involvement too large (\>20% BSA)
* Psoriasis involving only the scalp, groin, axillae, and/or other intertriginous areas

Primary outcomes:
measure: Overall Disease Severity Success (ODS)
timeFrame: 8 and 12 weeks
Secondary outcomes:
measure: Global Improvement Score
timeFrame: 2, 4, 8 and 12 weeks
measure: Signs of Psoriasis - Erythema
timeFrame: 2, 4, 8 and 12 weeks
measure: Signs of Psoriasis - Scaling
timeFrame: 2, 4, 8 and 12 weeks
measure: Signs of Psoriasis - Plaque Elevation
timeFrame: 2, 4, 8 and 12 weeks
measure: Percent Change From Baseline in Body Surface Area (% BSA) Affected
timeFrame: 2, 4, 8 and 12 weeks
measure: Overall Disease Severity
timeFrame: 2, 4, 8 and 12 weeks
measure: Tolerability Assessment - Pruritus
timeFrame: Baseline, 2, 4, 8 and 12 weeks
measure: Tolerability Assessment - Telangiectasias
timeFrame: Baseline, 2, 4, 8 and 12 weeks
measure: Tolerability Assessment - Stinging/ Burning
timeFrame: Baseline, 2, 4, 8 and 12 weeks
measure: Tolerability Assessment - Skin Atrophy
timeFrame: Baseline, 2, 4, 8 and 12 weeks
measure: Tolerability Assessment - Folliculitis
timeFrame: Baseline, 2, 4, 8 and 12 weeks
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Therapeutics Clinical Research
state: California
city: Newnan
country: United States
facility: MedaPhase, Inc.
state: Georgia
city: Snellville
country: United States
facility: Gwinnett Clinical Research Center, Inc
state: Georgia
city: Evansville
country: United States
facility: Hudson Dermatology
state: Indiana
city: New York
country: United States
facility: Mount Sinai Department of Dermatology
state: New York
city: Warren
country: United States
facility: Northeastern Ohio Universities College of Medicine
state: Ohio
city: Norman
country: United States
facility: Central Sooner Research
state: Oklahoma
city: College Station
country: United States
facility: J&J Studies, Inc
state: Texas
city: Houston
country: United States
facility: Suzanne Bruce and Associates, PA
state: Texas
city: Norfolk
country: United States
facility: Virginia Clinical Research, Inc
state: Virginia
city: Seattle
country: United States
facility: Dermatology Associates of Seattle, PLLC
state: Washington
city: Madison
country: United States
facility: Madison Skin and Research, Inc
state: Wisconsin
Study officials:
affiliation: Galderma R&D
name: Ronald W Gottschalk, MD
role: STUDY_DIRECTOR
References: