Effect of Topical Calcipotriene/Betamethasone (Taclonex) in Managing Localized Breakthrough in Moderate to Severe Plaque Psoriasis in Patients Receiving Efalizumab (Raptiva)

• Status: Terminated
• Trial end date: 2009-02-01
• Target enrollment: 0
• Participant gender: All

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) 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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Derm Research, PLLC
• Collaborator: Genentech, Inc.
• Treatments: Betamethasone; Betamethasone benzoate; Betamethasone sodium phosphate; Betamethasone Valerate; Betamethasone-17,21-dipropionate; Calcipotriene; Calcitriol

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.