Clinical trial NCT00608777: Effect of Topical Calcipotriene/Betamethasone (Taclonex) in Managing Localized Breakthrough in Moderate to Severe Plaque Psoriasis in Patients Receiving Efalizumab (Raptiva)
Official title: Effect of Topical Calcipotriene/Betamethasone (Taclonex) in Managing Localized Mild Breakthrough in Moderate to Severe Plaque Psoriasis Patients Receiving Efalizumab ( Raptiva).
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Plaque Psoriasis
Keywords: Localized mild breakthrough
Lead sponsor: Derm Research, PLLC
Sponsor class: OTHER
Collaborators: name: Genentech, Inc.
First posted: 2008-02-06
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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) 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.

Eligibility 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.

Primary outcomes:
measure: The Proportion of Subjects Who Acheive a Score of Clear (0) or Almost Clear (1) on the PGA of LMB at Week 2
timeFrame: week 2
Secondary outcomes:
Other outcomes:
Locations:
city: Louisville
country: United States
facility: DermResearch, PLLC
state: Kentucky
Study officials:
affiliation: DermResearch, PLLC
name: Leon H Kircik, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: de Jong EM. The course of psoriasis. Clin Dermatol. 1997 Sep-Oct;15(5):687-92. doi: 10.1016/s0738-081x(97)00023-0. No abstract available.
citation: Carey W, Glazer S, Gottlieb AB, Lebwohl M, Leonardi C, Menter A, Papp K, Rundle AC, Toth D. Relapse, rebound, and psoriasis adverse events: an advisory group report. J Am Acad Dermatol. 2006 Apr;54(4 Suppl 1):S171-81. doi: 10.1016/j.jaad.2005.10.029.
citation: Menter A, Leonardi CL, Sterry W, Bos JD, Papp KA. Long-term management of plaque psoriasis with continuous efalizumab therapy. J Am Acad Dermatol. 2006 Apr;54(4 Suppl 1):S182-8. doi: 10.1016/j.jaad.2005.10.028. No abstract available.
citation: Werther WA, Gonzalez TN, O'Connor SJ, McCabe S, Chan B, Hotaling T, Champe M, Fox JA, Jardieu PM, Berman PW, Presta LG. Humanization of an anti-lymphocyte function-associated antigen (LFA)-1 monoclonal antibody and reengineering of the humanized antibody for binding to rhesus LFA-1. J Immunol. 1996 Dec 1;157(11):4986-95.
citation: Raptiva Prescribing Information. Genentech, Inc. June 2005
citation: Taclonex Prescribing Information. Warner Chilcott (US), Inc. Jan 2006