NCT00608777

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

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

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Derm Research, PLLC · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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 experience suggests that LMB may not have a clinical impact in patients responding to efalizumab and therefore may be treated without interrupting efalizumab therapy. To relieve discomfort topical therapy may be indicated until the symptoms are resolved. This is a single arm, open label study. Fifteen patients who are receiving efalizumab before entrance into this study and who develop LMB wil be enrolled. Topical calcipotriene/betamethasone (Taclonex) will be applied to the areas (except face, axillae or groin) once a day for two weeks. The PI may choose to continue two more weeks if needed for a total of four weeks of therapy. All patients will continue with efalizumab without dose modification for the duration of the study. Patients will return for follow up visits at weeks 2, 4 and 6. Topical desonide may be used for LMB involvement of the face, groin or axillae.

Conditions

• Plaque Psoriasis

Interventions

Type	Name	Description
DRUG	Calcipotriene/betamethasone	One application to affected areas, once a day for two weeks. The PI may choose to extend treatment until Week 4 if necessary.

Timeline

• Start date: 2008-01-01
• Primary completion: 2009-02-01
• Completion: 2009-02-01
• First posted: 2008-02-06
• Last updated: 2012-08-10
• Results posted: 2012-04-03

Locations

1 site across 1 country: United States