Clinical trial NCT00988637: Evaluate Safety/Efficacy of Two Treatment Regimens for Vectical™ Ointment & Clobex® Spray for Moderate Plaque Psoriasis
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Plaque Psoriasis
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2009-10-02
Enrollment: 138
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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


Eligibility criteria: 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.)

Primary outcomes:
measure: 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
timeFrame: Baseline to Week 4
Secondary outcomes:
measure: 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
timeFrame: Baseline to week 2
measure: Number of Participants in Each Category of the Global Assessment of Improvement (GAI) Scale From Baseline to Week 4
timeFrame: Baseline to Week 4
measure: Number of Participants With a Decrease in Signs of Psoriasis (Erythema) Scores From Baseline to Week 4
timeFrame: Baseline to Week 4
measure: Number of Participants With Decrease in Signs of Psoriasis (Scaling) Scores From Baseline to Week 4
timeFrame: Baseline to Week 4
measure: Number of Participants With Decrease in Signs of Psoriasis (Plaque Elevation) Scores From Baseline to Week 4
timeFrame: Baseline to Week 4
measure: Median Percent (%) Change From Baseline in % Treatable BSA (Body Surface Area) From Baseline to Week 4
timeFrame: Baseline to Week 4
measure: Mean Change From Baseline Scores for the Koo-Menter Psoriasis Index 12-item Quality of Life Questionnaire (PQOL-12) From Baseline to Week 4
timeFrame: Baseline to Week 4
measure: 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
timeFrame: Baseline and Week 4
measure: 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
timeFrame: Week 4
measure: 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
timeFrame: Week 4
measure: 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
timeFrame: Week 4
measure: Number of Participants With Tolerability Assessments Resulting in Adverse Events From Baseline to Week 4
timeFrame: Baseline to Week 4
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Dermatology Research Associates
state: California
city: San Diego
country: United States
facility: Therapeutics Clinical Research
state: California
city: Evansville
country: United States
facility: Hudson Dermatology
state: Indiana
city: Fridley
country: United States
facility: Minnesota Clinical Study Center
state: Minnesota
city: Dallas
country: United States
facility: Baylor Research Institute Dermatology Research
state: Texas
city: Waterloo
country: Canada
facility: Probity Medical Research
state: Ontario
Study officials:
affiliation: Galderma R&D
name: Ronald W Gottschalk, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.