Phase 4 Open-Label Multicenter Community-based 4-Wk Trial to Assess Efficacy, Tolerance to Tx & Patient Satisfaction w/ CLOBEX® Spray When Used as Mono- or Add-on Therapy to Existing Systemic/Topical Agents for Tx of Plaque Psoriasis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Galderma R&D
- Enrollment
- 2,488
- Locations
- 1
- Primary Endpoint
- Efficacy - Change in Target Plaque Severity rating
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Other
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
1
Monotherapy - Subjects who are not currently being treated with anti-psoriatic medication and start using Clobex®
Intervention: Clobetasol Propionate, 0.05% (Drug)
2
Add-on therapy - Subjects who are taking some form of anti-psoriatic medication and add Clobex® treatment
Intervention: Clobetasol propionate, 0.05% Spray (Drug)
Outcomes
Primary Outcomes
Efficacy - Change in Target Plaque Severity rating
Time Frame: 4 weeks
Secondary Outcomes
- Safety - Evaluation of adverse events and tolerability(4 weeks)
- Efficacy - Self-Assessment of Quality of Life, Subject satisfaction(4 weeks)