Evaluate Safety/Efficacy of Two Treatment Regimens for Vectical™ Ointment & Clobex® Spray for Moderate Plaque Psoriasis

An Open-label, Multi-center, Randomized, Evaluator-Blinded Study to Evaluate the Safety and Efficacy of Two Treatment Regimens Involving Vectical™ (Calcitriol) Ointment 3 µg/g and Clobex® (Clobetasol Propionate) Spray, 0.05% in the Treatment of Moderate Plaque Psoriasis

This clinical trial will evaluate the efficacy and safety of Clobex® (clobetasol propionate) Spray 0.05% and Vectical™ (calcitriol) Ointment 3 µg/g over a four week period of use in one of two different regimens:

1. Vectical™ Ointment treatment, twice daily on weekdays (Mon - Fri) and Clobex® Spray treatment twice daily on weekends (Sat - Sun) for 28 days
2. Clobex® Spray once each morning and Vectical™ Ointment once each evening for 28 days

Study Overview

• Status: Completed
• Conditions: Plaque Psoriasis
• Intervention / Treatment: Drug: Vectical™ Ointment weekdays and Clobex® Spray weekends regimen; Drug: Clobex® Spray morning and Vectical™ Ointment evening regimen

• Study Type: Interventional
• Enrollment (Actual): 138
• Phase: Phase 4

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Waterloo, Ontario, Canada, N2J1C4
      • Probity Medical Research
• United States
  • California
    • Los Angeles, California, United States, 90045
      • Dermatology Research Associates
    • San Diego, California, United States, 92123
      • Therapeutics Clinical Research
  • Indiana
    • Evansville, Indiana, United States, 47714
      • Hudson Dermatology
  • Minnesota
    • Fridley, Minnesota, United States, 55432
      • Minnesota Clinical Study Center
  • Texas
    • Dallas, Texas, United States, 75246
      • Baylor Research Institute Dermatology Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male or female subjects aged 18 to 80 years inclusive
• Subjects with an Overall Disease Severity of 3 (moderate)
• Subjects with 3% - 10% treatable BSA (Body Surface Area) excluding scalp, face, groin, axillae and/or other intertriginous areas
• For concurrent medications, type and dose must have been stable for at least 3 months prior to study entry and not expected to change during the study. Subjects receiving treatment with beta-blockers or lithium, whose dose has been stable for at lest 6 months and who have shown no worsening of their psoriasis, may be included in the study, at the discretion of the investigator

Exclusion Criteria:

• Subjects with intakes of more than 2,000 IU/day (50 mcg/day) of vitamin D (tolerable upper intake level) and/or more than 1,000 mg/day of calcium
• Subjects whose psoriasis involves only the scalp, face, groin, axillae, and/or other intertriginous areas
• Subjects with a wash-out period for topical treatment less than 30 days (Any steroid containing medication, dovonex, anthralin, tar and/or UVB treatment)
• Subjects with a wash-out period for systemic treatment less than 12 weeks (corticosteroids, biologics and/or PUVA treatment; Examples of these therapies include, but are not limited to PUVA, Soriatane, Cyclosporine, Hydroxyurea, Mycophenolate mofetil, Sulfasalazine, Azathioprine, Alefacept, Efalizumab, Adalimumab, Etanercept, Infliximab, Rituximab, and Methotrexate)
• Subjects with non-plaque psoriasis or other related diseases not classified as plaque psoriasis
• Subjects who foresee intensive UV exposure during the study (mountain sports, UV radiation, sunbathing, etc.)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 1) Vectical™ Ointment and Clobex® Spray; Vectical™ Ointment weekdays & Clobex® Spray weekends regimen	Drug: Vectical™ Ointment weekdays and Clobex® Spray weekends regimen; Vectical™ Ointment 3 µg/g, topical, apply twice daily on weekdays (Mon-Fri) and Clobex® Spray 0.05% twice daily on weekends (Sat-Sun) for 28 days; Other Names: calcitriol ointment 3µg/g and clobetasol propionate spray 0.05%
Other: 2) Clobex® Spray and Vectical™ Ointment; Clobex® Spray morning and Vectical™ Ointment evening regimen	Drug: Clobex® Spray morning and Vectical™ Ointment evening regimen; Clobex® Spray 0.05%, topical, apply once each morning and Vectical™ Ointment 3 µg/g, topical, apply once each evening for 28 days; Other Names: clobetasol propionate spray 0.05% and calcitriol ointment 3 µg/g

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Who Were a Success (Clear/Almost Clear) of Plaque Psoriasis at Week 4 Based on the Overall Disease Severity (ODS), Full Ordinal Scale From Baseline to Week 4	Number of participants who were a success (Clear/Almost Clear) of Plaque Psoriasis at week 4 based on the Overall Disease Severity (ODS), full ordinal scale from baseline to week 4. Overall Disease Severity is evaluated on a scale from 0 - 4 (0 = Clear, 1 = Almost Clear, 2 = Mild, 3 = Moderate, 4 = Severe/Very Severe) with 0 being best and 4 being worst.	Baseline to Week 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Who Were a Success (Clear/Almost Clear) of Plaque Psoriasis at Week 2 Based on the Overall Disease Severity (ODS), Dichotomized Scale From Baseline to Week 2	Number of participants who were a success (Clear/Almost Clear) of Plaque Psoriasis at Week 2 based on the Overall Disease Severity (ODS), dichotomized scale from Baseline to Week 2. Overall Disease Severity is evaluated on a scale from 0 - 4 (0 = Clear, 1 = Almost Clear, 2 = Mild, 3 = Moderate, 4 = Severe/Very Severe) with 0 being best and 4 being worst.	Baseline to week 2
Number of Participants in Each Category of the Global Assessment of Improvement (GAI) Scale From Baseline to Week 4	Number of participants in each category of the Global Assessment of Improvement (GAI) Scale from Baseline to Week 4. The Global Assessment of Improvement is evaluated on a scale from -1 to 4 (-1 = Symptoms worse, 0 = No change, 1 = Minimal Improvement, 2 = Definite Improvement, 3 = Considerable Improvement and 4 = Clearing) with -1 being worst and 4 being best.	Baseline to Week 4
Number of Participants With a Decrease in Signs of Psoriasis (Erythema) Scores From Baseline to Week 4	Number of participants with a decrease in Signs of Psoriasis (Erythema) scores from Baseline to Week 4. Signs of Psoriasis (Erythema) are evaluated on a scale from 0 - 4 (0 = Clear, 1 = Almost Clear, 2 = Mild, 3 = Moderate, 4 = Severe/Very Severe with 0 being best and 4 being worst.	Baseline to Week 4
Number of Participants With Decrease in Signs of Psoriasis (Scaling) Scores From Baseline to Week 4	Number of participants with decrease in Signs of Psoriasis (Scaling) scores from Baseline to Week 4. Signs of Psoriasis (Scaling) are evaluated on a scale from 0 - 4 (0 = Clear, 1 = Almost Clear, 2 = Mild, 3 = Moderate, 4 = Severe/Very Severe) with 0 being best and 4 being worst.	Baseline to Week 4
Number of Participants With Decrease in Signs of Psoriasis (Plaque Elevation) Scores From Baseline to Week 4	Number of participants with decrease in Signs of Psoriasis (Plaque Elevation) scores from Baseline to Week 4. Signs of Psoriasis (Plaque Elevation) are evaluated on a scale from 0 - 4 (0 = Clear, 1 = Almost Clear, 2 = Mild, 3 = Moderate, 4 = Severe/Very Severe) with 0 being best and 4 being worst.	Baseline to Week 4
Median Percent (%) Change From Baseline in % Treatable BSA (Body Surface Area) From Baseline to Week 4	Median percent (%) change from baseline in % treatable BSA (Body Surface Area) from Baseline to Week 4	Baseline to Week 4
Mean Change From Baseline Scores for the Koo-Menter Psoriasis Index 12-item Quality of Life Questionnaire (PQOL-12) From Baseline to Week 4	Mean change from baseline scores for the Koo-Menter Psoriasis Index 12-item Quality of Life Questionnaire (PQOL-12) from Baseline to Week 4. The Koo-Menter Psoriasis Index is a questionnaire with 12 questions that can be used to assess the effect that psoriasis has on a patient's overall quality of life. The questions are answered on a scale from 0 to 10 with 0 being best and 10 being worst.	Baseline to Week 4
Number of Participants Who Responded to the Categories of Possible Answers to the Subject's Satisfaction Survey Question "The Treatment Program Was Easy to Follow" at Week 4	Number of participants who responded to the categories of possible answers to the Subject's Satisfaction Survey question "The treatment program was easy to follow" at Week 4. Categories of possible answers include Strongly agree, Moderately agree, No opinion, Moderately disagree, and Strongly disagree.	Baseline and Week 4
Number of Participants Who Responded to the Categories of Possible Answers to the Subject's Satisfaction Survey Question "I am Satisfied With my Appearance" at Week 4	Number of participants who responded to the categories of possible answers to the Subject's Satisfaction Survey question "I am Satisfied with my Appearance" at Week 4. Categories of possible answers include Strongly agree, Moderately agree, No opinion, Moderately disagree, and Strongly disagree.	Week 4
Number of Participants Who Responded to the Categories of Possible Answers to the Subject's Satisfaction Survey Question "I am Satisfied With the Results of This Treatment Program" at Week 4	Number of participants who responded to the categories of possible answers to the Subject's Satisfaction Survey question "I am satisfied with the results of this treatment program" at Week 4. Categories of possible answers include Strongly agree, Moderately agree, No opinion, Moderately disagree, and Strongly disagree.	Week 4
Number of Participants Who Responded to the Categories of Possible Answers to the Subject's Satisfaction Survey Question "I Would Use This Treatment Program Again if Recommended by the Dermatologist" at Week 4	Number of participants who responded to the categories of possible answers to the Subject's Satisfaction Survey question "I would use this treatment program again if recommended by the dermatologist" at Week 4. Categories of possible answers include Strongly agree, Moderately agree, No opinion, Moderately disagree, and Strongly disagree.	Week 4
Number of Participants With Tolerability Assessments Resulting in Adverse Events From Baseline to Week 4	Number of participants with Tolerability Assessments resulting in Adverse Events from baseline to week 4. Tolerability assessments (Pruritus, telangiectasias, and stinging/burning) are evaluated on a scale from 0 - 3 (0 = None, 1 = Mild, 2 = Moderate, 3 = Severe) with 0 being best and 3 being worst. Skin atrophy and folliculitis are evaluated as absent or present. Changes in tolerability assessments that require a dose modification or concomitant medications/therapy are recorded as adverse events.	Baseline to Week 4

Collaborators and Investigators

• Sponsor: Galderma R&D

Publications and helpful links

General Publications

• Hudson CP, Kempers S, Menter A, Papp K, Smith S, Sofen H, Colon LE, Johnson LA, Gottschalk R. An open-label, multicenter study of the efficacy and safety of a weekday/weekend treatment regimen with calcitriol ointment 3 microg/g and clobetasol propionate spray 0.05% in the management of plaque psoriasis. Cutis. 2011 Oct;88(4):201-7.
• Menter A, Sofen H, Smith S, Papp K, Kempers S, Hudson CP, Colon LE, Johnson LA, Gottschalk R. An open-label, multicenter study of the efficacy and safety of an AM/PM treatment regimen with clobetasol propionate spray 0.05% and calcitriol ointment 3 microg/g in the management of plaque psoriasis. Cutis. 2011 Jul;88(1):46-51.

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (Actual): March 1, 2010
• Study Completion (Actual): March 1, 2010

Study Registration Dates

• First Submitted: October 1, 2009
• First Submitted That Met QC Criteria: October 1, 2009
• First Posted (Estimate): October 2, 2009

Study Record Updates

• Last Update Posted (Actual): August 1, 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: US10144