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Safety & Effectiveness of Clobex Spray, Followed by Calcitriol Ointment in Management of Plaque Psoriasis

Primary Purpose

Psoriasis

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
clobetasol propionate spray 0.05%
calcitriol ointment
Sponsored by
Galderma R&D
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psoriasis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Therapeutics Clinical Research
  • MedaPhase, Inc.
  • Gwinnett Clinical Research Center, Inc
  • Hudson Dermatology
  • Mount Sinai Department of Dermatology
  • Northeastern Ohio Universities College of Medicine
  • Central Sooner Research
  • J&J Studies, Inc
  • Suzanne Bruce and Associates, PA
  • Virginia Clinical Research, Inc
  • Dermatology Associates of Seattle, PLLC
  • Madison Skin and Research, Inc

Arms of the Study

Arm 1

Arm Type

Active Comparator

Arm Label

Study Treatment

Arm Description

clobetasol propionate spray 0.05% Other Names: Clobex® Spray 0.05% clobetasol propionate spray, 0.05%, applied topically twice daily calcitriol ointment Other Names: Calcitriol Ointment calcitriol ointment, 3 µg/g, applied topically, not to exceed 30 g daily

Outcomes

Primary Outcome Measures

Overall Disease Severity Success (ODS)
Success was defined as a one-grade improvement in ODS from baseline.

Secondary Outcome Measures

Global Improvement Score
Signs of Psoriasis - Erythema
Signs of Psoriasis - Scaling
Signs of Psoriasis - Plaque Elevation
Percent Change From Baseline in Body Surface Area (% BSA) Affected
Overall Disease Severity
Tolerability Assessment - Pruritus
Tolerability Assessment - Telangiectasias
Tolerability Assessment - Stinging/ Burning
Tolerability Assessment - Skin Atrophy
Tolerability Assessment - Folliculitis

Full Information

First Posted
March 4, 2008
Last Updated
July 28, 2022
Sponsor
Galderma R&D
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1. Study Identification

Unique Protocol Identification Number
NCT00658788
Brief Title
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

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
January 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Galderma R&D

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
305 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Study Treatment
Arm Type
Active Comparator
Arm Description
clobetasol propionate spray 0.05% Other Names: Clobex® Spray 0.05% clobetasol propionate spray, 0.05%, applied topically twice daily calcitriol ointment Other Names: Calcitriol Ointment calcitriol ointment, 3 µg/g, applied topically, not to exceed 30 g daily
Intervention Type
Drug
Intervention Name(s)
clobetasol propionate spray 0.05%
Other Intervention Name(s)
Clobex® Spray 0.05%
Intervention Description
clobetasol propionate spray, 0.05%, applied topically twice daily
Intervention Type
Drug
Intervention Name(s)
calcitriol ointment
Intervention Description
calcitriol ointment, 3 µg/g, applied topically, not to exceed 30 g daily
Primary Outcome Measure Information:
Title
Overall Disease Severity Success (ODS)
Description
Success was defined as a one-grade improvement in ODS from baseline.
Time Frame
8 and 12 weeks
Secondary Outcome Measure Information:
Title
Global Improvement Score
Time Frame
2, 4, 8 and 12 weeks
Title
Signs of Psoriasis - Erythema
Time Frame
2, 4, 8 and 12 weeks
Title
Signs of Psoriasis - Scaling
Time Frame
2, 4, 8 and 12 weeks
Title
Signs of Psoriasis - Plaque Elevation
Time Frame
2, 4, 8 and 12 weeks
Title
Percent Change From Baseline in Body Surface Area (% BSA) Affected
Time Frame
2, 4, 8 and 12 weeks
Title
Overall Disease Severity
Time Frame
2, 4, 8 and 12 weeks
Title
Tolerability Assessment - Pruritus
Time Frame
Baseline, 2, 4, 8 and 12 weeks
Title
Tolerability Assessment - Telangiectasias
Time Frame
Baseline, 2, 4, 8 and 12 weeks
Title
Tolerability Assessment - Stinging/ Burning
Time Frame
Baseline, 2, 4, 8 and 12 weeks
Title
Tolerability Assessment - Skin Atrophy
Time Frame
Baseline, 2, 4, 8 and 12 weeks
Title
Tolerability Assessment - Folliculitis
Time Frame
Baseline, 2, 4, 8 and 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ronald W Gottschalk, MD
Organizational Affiliation
Galderma R&D
Official's Role
Study Director
Facility Information:
Facility Name
Therapeutics Clinical Research
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
MedaPhase, Inc.
City
Newnan
State/Province
Georgia
ZIP/Postal Code
30263
Country
United States
Facility Name
Gwinnett Clinical Research Center, Inc
City
Snellville
State/Province
Georgia
ZIP/Postal Code
30078
Country
United States
Facility Name
Hudson Dermatology
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47714
Country
United States
Facility Name
Mount Sinai Department of Dermatology
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Northeastern Ohio Universities College of Medicine
City
Warren
State/Province
Ohio
ZIP/Postal Code
44483
Country
United States
Facility Name
Central Sooner Research
City
Norman
State/Province
Oklahoma
ZIP/Postal Code
73069
Country
United States
Facility Name
J&J Studies, Inc
City
College Station
State/Province
Texas
ZIP/Postal Code
77840
Country
United States
Facility Name
Suzanne Bruce and Associates, PA
City
Houston
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Virginia Clinical Research, Inc
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
Dermatology Associates of Seattle, PLLC
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
Madison Skin and Research, Inc
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53719
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Safety & Effectiveness of Clobex Spray, Followed by Calcitriol Ointment in Management of Plaque Psoriasis

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