Effect of Topical Calcipotriene/Betamethasone (Taclonex)in Managing Localized Breakthrough in Moderate to Severe Plaque Psoriasis in Patients Receiving Efalizumab (Raptiva)
Information source: Derm Research, PLLC
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Localized Mild Breakthrough; Plaque Psoriasis
Intervention: Calcipotriene/betamethasone (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Derm Research, PLLC Official(s) and/or principal investigator(s):
Leon H Kircik, M.D., Principal Investigator, Affiliation: DermResearch, PLLC
Overall contact:
Leon H Kircik, M.D., Phone: 502-451-9000, Email: wedoderm@bellsouth.net
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.
Clinical Details
Official title: Effect of Topical Calcipotriene/Betamethasone (Taclonex) in Managing Localized Mild Breakthrough in Moderate to Severe Plaque Psoriasis Patients Receiving Efalizumab ( Raptiva).
Study design: Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Primary outcome: The proportion of subjects who acheive a score of clear (0) on the PGA of LMB at week 2.
Secondary outcome: The proportion of subjects who acheive a score of clear (0) or almost clear (1) on the PGA og LMB at weeks 4 and 6.The incidence of adverse events caused by calcipotriene/betamethasone (Taclonex) at weeks 2, 4 and 6.
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Leon H Kircik, M.D., Phone: 502-451-9000, Email: wedoderm@bellsouth.net
DermResearch, PLLC, Louisville, Kentucky 40217, United States; Recruiting
Leon H Kircik, M.D., Phone: 502-451-9000, Email: wedoderm@bellsouth.net
Deborah B Zuidema, M.S.N., Phone: 502-456-4161, Email: wedoderm@bellsouth.net
Leon H Kircik, M.D., Principal Investigator
Additional Information
Related publications: De Jong, EM The course of psoriasis. Clinical Dermatology 1997; 15: 687-692 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. Review. 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. Review. No abstract available. 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.
Starting date: January 2008
Ending date: July 2008
Last updated: January 23, 2008
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