Plaque Psoriasis
Conditions
Brief summary
Evaluate the efficacy of Clobex® Spray as compared to Taclonex® Ointment in terms of Overall Disease Severity and Investigator Global Assessment.
Detailed description
Same as above.
Interventions
Topical, twice daily for 4 weeks
DRUGCalcipotriene and betamethasone dipropionate ointment
Topical, once daily
Sponsors
Galderma R&D
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Moderate to severe psoriasis involving 3-20% of the body surface area
Exclusion criteria
* Subjects who have surface area involvement too large that would require more than 50 grams per week of Clobex® Spray or more than 100 grams per week of Taclonex® Ointment * Subjects having psoriasis that involves the scalp, face, or groin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Disease Severity | End of treatment (Week 4) |
| Tolerability assessments, incidence of adverse events | Baseline, Weeks 1, 2, 4 and 8 |
Secondary
| Measure | Time frame |
|---|---|
| Overall Disease Severity | Weeks 1, 2 and 8 |
| Investigator Global Assessment | End of treatment (week 4) and Weeks 1, 2 and 8 |
Countries
United States
Outcome results
None listed