Status:
TERMINATED
Effect of Topical Calcipotriene/Betamethasone (Taclonex) in Managing Localized Breakthrough in Moderate to Severe Plaque Psoriasis in Patients Receiving Efalizumab (Raptiva)
Lead Sponsor:
Derm Research, PLLC
Collaborating Sponsors:
Genentech, Inc.
Conditions:
Plaque Psoriasis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to determine if calcipotriene/bethamethasone can safely and effectively manage the occurence of LMB (mild localized breakthrough) in patients recieving efalizumab (Raptiva...
Detailed Description
LMB (localized mild breakthrough)is one of two psoriasis adverse events commonly seen in efalizumab treated patients. It is generally papular in nature and does not involve existing lesions. Clinical ...
Eligibility Criteria
Inclusion
- Ability to provide written, informed consent and comply with study assessments for the full duration of the study.
- Age 18 years or older.
- Moderate to severe plaque psoriasis being treated with efalizumab.
- Develop LMB during efalizumab treatment.
- PGA of LMB at least mild (2) excluding face, axillae and groin.
Exclusion
- Patients with known hypersensitivity to efalizumab, calcipotriene/betamethasone or any of its components.
- Pregnant or lactating women.
- Known or suspected disorders of calcium metabolism.
- Erythrodermic, exfoliative and/or pustular psoriasis.
- Concomitant use of topical thaerapy, phototherapy or immunosuppressive agents.
- LMB (in areas other than face, axillae or groin) constitutes more than 30% of total body surface area.
- Patients with generalized inflammatory flare which is defined as widespread worsening of psoriasis characterized by erythematous and and edematous lesions within exisiting plaques.
- Any other condition the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated.
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2009
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT00608777
Start Date
January 1 2008
End Date
February 1 2009
Last Update
August 10 2012
Active Locations (1)
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1
DermResearch, PLLC
Louisville, Kentucky, United States, 40217