Effect of Topical Calcipotriene/Betamethasone (Taclonex) in Managing Localized Breakthrough in Moderate to Severe Plaque Psoriasis in Patients Receiving Efalizumab (Raptiva)
Stopped early · Phase 4
Conditions studied: Plaque Psoriasis
In brief
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) for moderate to severe plaque psoriasis. It is hypothesized that calcipotriene/betamethasone (Taclonex) could be used to manage LMB and thus allow patients to continue efalizumab without interruption.
Key facts
- Study ID
- NCT00608777
- Run by
- Derm Research, PLLC
- People needed
- 6
- Starts
- 2008-01-01
- Expected to finish
- 2009-02-01
- Last updated by the study team
- 2012-08-10
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- DermResearch, PLLC — Louisville, Kentucky, United States
Full record on ClinicalTrials.gov
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