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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

138 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2010-03-31

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:

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

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Detailed Description

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Conditions

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Plaque Psoriasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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1) Vectical™ Ointment and Clobex® Spray

Vectical™ Ointment weekdays \& Clobex® Spray weekends regimen

Group Type OTHER

Vectical™ Ointment weekdays and Clobex® Spray weekends regimen

Intervention Type DRUG

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

2) Clobex® Spray and Vectical™ Ointment

Clobex® Spray morning and Vectical™ Ointment evening regimen

Group Type OTHER

Clobex® Spray morning and Vectical™ Ointment evening regimen

Intervention Type DRUG

Clobex® Spray 0.05%, topical, apply once each morning and Vectical™ Ointment 3 µg/g, topical, apply once each evening for 28 days

Interventions

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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

Intervention Type 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

Intervention Type DRUG

Other Intervention Names

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calcitriol ointment 3µg/g and clobetasol propionate spray 0.05% clobetasol propionate spray 0.05% and calcitriol ointment 3 µg/g

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.)

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No