Psoriasis Clinical Trial

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

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:

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

View Eligibility Criteria

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.)

Study is for people with:

Psoriasis

Phase:

Phase 4

Estimated Enrollment:

138

Study ID:

NCT00988637

Recruitment Status:

Completed

Sponsor:

Galderma R&D

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There are 6 Locations for this study

See Locations Near You

Dermatology Research Associates
Los Angeles California, 90045, United States
Therapeutics Clinical Research
San Diego California, 92123, United States
Hudson Dermatology
Evansville Indiana, 47714, United States
Minnesota Clinical Study Center
Fridley Minnesota, 55432, United States
Baylor Research Institute Dermatology Research
Dallas Texas, 75246, United States
Probity Medical Research
Waterloo Ontario, N2J1C, Canada

How clear is this clinincal trial information?

Study is for people with:

Psoriasis

Phase:

Phase 4

Estimated Enrollment:

138

Study ID:

NCT00988637

Recruitment Status:

Completed

Sponsor:


Galderma R&D

How clear is this clinincal trial information?

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