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

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

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.

Study Overview

• Status: Completed
• Conditions: Psoriasis
• Intervention / Treatment: Drug: clobetasol propionate spray 0.05%; Drug: calcitriol ointment

Detailed Description

Same as above.

• Study Type: Interventional
• Enrollment (Actual): 305
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92123
      • Therapeutics Clinical Research
  • Georgia
    • Newnan, Georgia, United States, 30263
      • MedaPhase, Inc.
    • Snellville, Georgia, United States, 30078
      • Gwinnett Clinical Research Center, Inc
  • Indiana
    • Evansville, Indiana, United States, 47714
      • Hudson Dermatology
  • New York
    • New York, New York, United States, 10029
      • Mount Sinai Department of Dermatology
  • Ohio
    • Warren, Ohio, United States, 44483
      • Northeastern Ohio Universities College of Medicine
  • Oklahoma
    • Norman, Oklahoma, United States, 73069
      • Central Sooner Research
  • Texas
    • College Station, Texas, United States, 77840
      • J&J Studies, Inc
    • Houston, Texas, United States, 75390
      • Suzanne Bruce and Associates, PA
  • Virginia
    • Norfolk, Virginia, United States, 23507
      • Virginia Clinical Research, Inc
  • Washington
    • Seattle, Washington, United States, 98101
      • Dermatology Associates of Seattle, PLLC
  • Wisconsin
    • Madison, Wisconsin, United States, 53719
      • Madison Skin and Research, Inc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	Drug: clobetasol propionate spray 0.05%; clobetasol propionate spray, 0.05%, applied topically twice daily; Other Names: Clobex® Spray 0.05%; Drug: calcitriol ointment; calcitriol ointment, 3 µg/g, applied topically, not to exceed 30 g daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Disease Severity Success (ODS)	Success was defined as a one-grade improvement in ODS from baseline.	8 and 12 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Global Improvement Score	2, 4, 8 and 12 weeks
Signs of Psoriasis - Erythema	2, 4, 8 and 12 weeks
Signs of Psoriasis - Scaling	2, 4, 8 and 12 weeks
Signs of Psoriasis - Plaque Elevation	2, 4, 8 and 12 weeks
Percent Change From Baseline in Body Surface Area (% BSA) Affected	2, 4, 8 and 12 weeks
Overall Disease Severity	2, 4, 8 and 12 weeks
Tolerability Assessment - Pruritus	Baseline, 2, 4, 8 and 12 weeks
Tolerability Assessment - Telangiectasias	Baseline, 2, 4, 8 and 12 weeks
Tolerability Assessment - Stinging/ Burning	Baseline, 2, 4, 8 and 12 weeks
Tolerability Assessment - Skin Atrophy	Baseline, 2, 4, 8 and 12 weeks
Tolerability Assessment - Folliculitis	Baseline, 2, 4, 8 and 12 weeks

Collaborators and Investigators

• Sponsor: Galderma R&D

Study record dates

Study Major Dates

• Study Start: March 1, 2008
• Primary Completion (Actual): January 1, 2009
• Study Completion (Actual): January 1, 2009

Study Registration Dates

• First Submitted: March 4, 2008
• First Submitted That Met QC Criteria: April 9, 2008
• First Posted (Estimate): April 15, 2008

Study Record Updates

• Last Update Posted (Actual): August 23, 2022
• Last Update Submitted That Met QC Criteria: July 28, 2022
• Last Verified: September 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Micronutrients; Membrane Transport Modulators; Vitamins; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vasoconstrictor Agents; Calcium Channel Agonists; Clobetasol; Calcitriol
• Other Study ID Numbers: US10085