Status:
COMPLETED
Evaluate Safety/Efficacy of Two Treatment Regimens for Vectical™ Ointment & Clobex® Spray for Moderate Plaque Psoriasis
Lead Sponsor:
Galderma R&D
Conditions:
Plaque Psoriasis
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
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 differe...
Eligibility Criteria
Inclusion
- 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
- 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.)
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
138 Patients enrolled
Trial Details
Trial ID
NCT00988637
Start Date
October 1 2009
End Date
March 1 2010
Last Update
August 1 2022
Active Locations (6)
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1
Dermatology Research Associates
Los Angeles, California, United States, 90045
2
Therapeutics Clinical Research
San Diego, California, United States, 92123
3
Hudson Dermatology
Evansville, Indiana, United States, 47714
4
Minnesota Clinical Study Center
Fridley, Minnesota, United States, 55432