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

Galderma

Status and phase

Completed

Phase 4

Conditions

Plaque Psoriasis

Treatments

Drug: Clobex® Spray morning and Vectical™ Ointment evening regimen

Drug: Vectical™ Ointment weekdays and Clobex® Spray weekends regimen

Study type

Interventional

Funder types

Industry

Identifiers

NCT00988637

US10144

Details and patient eligibility

About

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

Enrollment

138 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.)