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

Completed · Phase 4

Conditions studied: Plaque Psoriasis

In brief

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

Key facts

Study ID

NCT00988637

Run by

Galderma R&D

People needed

138

Starts

2009-10-01

Expected to finish

2010-03-01

Last updated by the study team

2022-08-01

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.)

Where it is running

• Dermatology Research Associates — Los Angeles, California, United States
• Therapeutics Clinical Research — San Diego, California, United States
• Hudson Dermatology — Evansville, Indiana, United States
• Minnesota Clinical Study Center — Fridley, Minnesota, United States
• Baylor Research Institute Dermatology Research — Dallas, Texas, United States
• Probity Medical Research — Waterloo, Ontario, Canada

Full record on ClinicalTrials.gov

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