Efficacy, Tolerance and Satisfaction With CLOBEX® Spray When Used as Monotherapy or Add-on Therapy in Plaque Psoriasis
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
1 other identifier
observational
2,488
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2006
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2006
CompletedFirst Submitted
Initial submission to the registry
February 16, 2007
CompletedFirst Posted
Study publicly available on registry
February 19, 2007
CompletedJuly 29, 2022
March 1, 2008
5 months
February 16, 2007
July 28, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Efficacy - Change in Target Plaque Severity rating
4 weeks
Secondary Outcomes (2)
Efficacy - Self-Assessment of Quality of Life, Subject satisfaction
4 weeks
Safety - Evaluation of adverse events and tolerability
4 weeks
Study Arms (2)
1
Monotherapy - Subjects who are not currently being treated with anti-psoriatic medication and start using Clobex®
2
Add-on therapy - Subjects who are taking some form of anti-psoriatic medication and add Clobex® treatment
Interventions
Apply twice daily for 2 or 4 weeks as monotherapy
Apply twice daily for 2 or 4 weeks as add-on therapy
Eligibility Criteria
Community Sample
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Galderma R&Dlead
Study Sites (1)
DHC Dimensional HealthCare, Inc. (Clinical Research Organization)
Cedar Knolls, New Jersey, 76117, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ronald W Gottschalk, MD
Galderma Laboratories, LP
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- OTHER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
February 16, 2007
First Posted
February 19, 2007
Study Start
February 1, 2006
Primary Completion
July 1, 2006
Study Completion
July 1, 2006
Last Updated
July 29, 2022
Record last verified: 2008-03