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

• Sponsor: Galderma Laboratories, L.P.
• Information provided by (Responsible Party): Galderma Laboratories, L.P.

Tracking Information

• First Submitted Date: March 4, 2008
• First Posted Date: April 15, 2008
• Results First Submitted Date: August 12, 2014
• Results First Posted Date: August 27, 2014
• Last Update Posted Date: August 27, 2014
• Study Start Date: March 2008
• Actual Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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 (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 (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: 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
• 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: Interventional
• Study Phase: Phase 3
• Study Design: Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Psoriasis

Intervention

• 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

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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 31, 2009): 305
• Original Estimated Enrollment (submitted: April 9, 2008): 300
• Actual Study Completion Date: January 2009
• Actual Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00658788
• Other Study ID Numbers: US10085
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Galderma Laboratories, L.P.
• Study Sponsor: Galderma Laboratories, L.P.
• Collaborators: Not Provided

Investigators

• Study Director: Ronald W Gottschalk, MD; Galderma Laboratories, L.P.

• PRS Account: Galderma Laboratories, L.P.
• Verification Date: September 2012