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

Study Overview
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Brief Summary
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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: Vectical™ Ointment treatment, twice daily on weekdays (Mon - Fri) and Clobex® Spray treatment twice daily on weekends (Sat - Sun) for 28 days Clobex® Spray once each morning and Vectical™ Ointment once each evening for 28 days

Official Title
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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

Conditions
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Plaque Psoriasis

Intervention / Treatment
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* Drug: Vectical™ Ointment weekdays and Clobex® Spray weekends regimen
* Drug: Clobex® Spray morning and Vectical™ Ointment evening regimen


Participation Criteria
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Eligibility Criteria
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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.)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1) Vectical™ Ointment and Clobex® Spray<br>Vectical™ Ointment weekdays & Clobex® Spray weekends regimen | Drug: Vectical™ Ointment weekdays and Clobex® Spray weekends regimen<br>* 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<br>* Other names: calcitriol ointment 3µg/g and clobetasol propionate spray 0.05%;|
| Other: 2) Clobex® Spray and Vectical™ Ointment<br>Clobex® Spray morning and Vectical™ Ointment evening regimen | Drug: Clobex® Spray morning and Vectical™ Ointment evening regimen<br>* Clobex® Spray 0.05%, topical, apply once each morning and Vectical™ Ointment 3 µg/g, topical, apply once each evening for 28 days<br>* Other names: clobetasol propionate spray 0.05% and calcitriol ointment 3 µg/g;|

What is the study measuring?
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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 |