Psoriasis
Conditions
Brief summary
Evaluation of the effectiveness of Clobex® Spray, 0.05% when used as monotherapy or add-on therapy to existing systemic or topical anti-psoriatic agents.
Detailed description
Evaluation of the effectiveness of Clobex® Spray, 0.05% when used as monotherapy or add-on therapy to existing systemic or topical anti-psoriatic agents, as determined by the change in the target plaque severity (TPS) rating between Weeks 0 and 4.
Interventions
Apply twice daily for 2 or 4 weeks as monotherapy
DRUGClobetasol propionate, 0.05% Spray
Apply twice daily for 2 or 4 weeks as add-on therapy
Sponsors
Galderma R&D
Study design
Observational model
CASE_ONLY
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Moderate to severe plaque psoriasis between 3% and 20% of Body Surface Area (BSA) with a target plaque severity (TPS) of moderate to severe * At least 1 target site (not on the palms or soles of the feet) with a TPS rating of moderate to severe and with 1 or more elevated, easily palpable, plaques having well-circumscribed margins, and at least 1 cm in diameter * History of stable plaque psoriasis of greater than or equal to 3 months
Exclusion criteria
* Diagnosis of guttate, generalized pustular, erythrodermic, psoriatic arthritis, or nail psoriasis as the sole or predominant form of psoriasis * Psoriatic arthritis that was not stable or might have required a change in medication during the 4-week study period * Plaque psoriasis requiring treatment on the face, scalp, neck, groin, and armpits
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy - Change in Target Plaque Severity rating | 4 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy - Self-Assessment of Quality of Life, Subject satisfaction | 4 weeks |
| Safety - Evaluation of adverse events and tolerability | 4 weeks |
Countries
United States
Outcome results
None listed