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

This study has been terminated.
(Withdrawal of marketing autorization of efalizumab by the EMEA.)
Genentech, Inc.
Information provided by (Responsible Party):
Leon Kircik, M.D., Derm Research, PLLC Identifier:
First received: January 23, 2008
Last updated: August 7, 2012
Last verified: August 2012

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.

Condition Intervention Phase
Plaque Psoriasis Drug: Calcipotriene/betamethasone Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Topical Calcipotriene/Betamethasone (Taclonex) in Managing Localized Mild Breakthrough in Moderate to Severe Plaque Psoriasis Patients Receiving Efalizumab ( Raptiva).

Resource links provided by NLM:

Further study details as provided by Leon Kircik, M.D., Derm Research, PLLC:

Primary Outcome Measures:
  • The Proportion of Subjects Who Acheive a Score of Clear (0) or Almost Clear (1) on the PGA of LMB at Week 2 [ Time Frame: week 2 ]

Enrollment: 6
Study Start Date: January 2008
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
    Other Name: Taclonex
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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00608777

United States, Kentucky
DermResearch, PLLC
Louisville, Kentucky, United States, 40217
Sponsors and Collaborators
Derm Research, PLLC
Genentech, Inc.
Principal Investigator: Leon H Kircik, M.D. DermResearch, PLLC
  More Information

Responsible Party: Leon Kircik, M.D., Principal Investigator, Derm Research, PLLC Identifier: NCT00608777     History of Changes
Other Study ID Numbers: ACD4311s
Study First Received: January 23, 2008
Results First Received: March 5, 2012
Last Updated: August 7, 2012

Keywords provided by Leon Kircik, M.D., Derm Research, PLLC:
Localized mild breakthrough

Additional relevant MeSH terms:
Skin Diseases, Papulosquamous
Skin Diseases
Betamethasone benzoate
Betamethasone Valerate
Betamethasone sodium phosphate
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Calcium Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasoconstrictor Agents
Growth Substances
Bone Density Conservation Agents processed this record on August 17, 2017