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

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ClinicalTrials.gov Identifier: NCT00658788
Recruitment Status : Completed
First Posted : April 15, 2008
Results First Posted : August 27, 2014
Last Update Posted : August 27, 2014
Sponsor:
Information provided by (Responsible Party):
Galderma Laboratories, L.P.

Tracking Information
First Submitted Date  ICMJE March 4, 2008
First Posted Date  ICMJE April 15, 2008
Results First Submitted Date  ICMJE August 12, 2014
Results First Posted Date  ICMJE August 27, 2014
Last Update Posted Date August 27, 2014
Study Start Date  ICMJE March 2008
Actual Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 12, 2014)
Overall Disease Severity Success (ODS) [ Time Frame: 8 and 12 weeks ]
Success was defined as a one-grade improvement in ODS from baseline.
Original Primary Outcome Measures  ICMJE
 (submitted: April 9, 2008)
Efficacy - Percent of Subjects with an improvement from baseline in Overall Disease Severity score [ Time Frame: 12 weeks ]
Change History Complete list of historical versions of study NCT00658788 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 12, 2014)
  • Global Improvement Score [ Time Frame: 2, 4, 8 and 12 weeks ]
  • Signs of Psoriasis - Erythema [ Time Frame: 2, 4, 8 and 12 weeks ]
  • Signs of Psoriasis - Scaling [ Time Frame: 2, 4, 8 and 12 weeks ]
  • Signs of Psoriasis - Plaque Elevation [ Time Frame: 2, 4, 8 and 12 weeks ]
  • Percent Change From Baseline in Body Surface Area (% BSA) Affected [ Time Frame: 2, 4, 8 and 12 weeks ]
  • Overall Disease Severity [ Time Frame: 2, 4, 8 and 12 weeks ]
  • Tolerability Assessment - Pruritus [ Time Frame: Baseline, 2, 4, 8 and 12 weeks ]
  • Tolerability Assessment - Telangiectasias [ Time Frame: Baseline, 2, 4, 8 and 12 weeks ]
  • Tolerability Assessment - Stinging/ Burning [ Time Frame: Baseline, 2, 4, 8 and 12 weeks ]
  • Tolerability Assessment - Skin Atrophy [ Time Frame: Baseline, 2, 4, 8 and 12 weeks ]
  • Tolerability Assessment - Folliculitis [ Time Frame: Baseline, 2, 4, 8 and 12 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: April 9, 2008)
  • Efficacy - Percent of Subjects with an improvement from baseline in Overall Disease Severity score [ Time Frame: 8 weeks ]
  • Efficacy - Overall Disease Severity, Global Improvement Score, Signs of Psoriasis, Percent change from baseline in Body Surface Area [ Time Frame: 2, 4, 8 and 12 weeks ]
  • Efficacy - Koo-Menter Psoriasis Qualify of Life Questionnaire; Subject Satisfaction Survey [ Time Frame: 12 weeks ]
  • Safety - Tolerability, adverse events [ Time Frame: 12 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety & Effectiveness of Clobex Spray, Followed by Calcitriol Ointment in Management of Plaque Psoriasis
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Psoriasis
Intervention  ICMJE
  • Drug: clobetasol propionate spray 0.05%
    clobetasol propionate spray, 0.05%, applied topically twice daily
    Other Name: Clobex® Spray 0.05%
  • Drug: calcitriol ointment
    calcitriol ointment, 3 µg/g, applied topically, not to exceed 30 g daily
Study Arms  ICMJE Active Comparator: Study Treatment

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

Interventions:
  • Drug: clobetasol propionate spray 0.05%
  • Drug: calcitriol ointment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 31, 2009)
305
Original Estimated Enrollment  ICMJE
 (submitted: April 9, 2008)
300
Actual Study Completion Date  ICMJE January 2009
Actual Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00658788
Other Study ID Numbers  ICMJE US10085
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Galderma Laboratories, L.P.
Study Sponsor  ICMJE Galderma Laboratories, L.P.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Ronald W Gottschalk, MD Galderma Laboratories, L.P.
PRS Account Galderma Laboratories, L.P.
Verification Date September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP