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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.)
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
Leon Kircik, M.D., Derm Research, PLLC
ClinicalTrials.gov Identifier:
NCT00608777
First received: January 23, 2008
Last updated: August 7, 2012
Last verified: August 2012
  Purpose

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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 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 ] [ Designated as safety issue: No ]

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00608777

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

Publications:
Responsible Party: Leon Kircik, M.D., Principal Investigator, Derm Research, PLLC
ClinicalTrials.gov 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
Health Authority: United States: Institutional Review Board

Keywords provided by Derm Research, PLLC:
Localized mild breakthrough

Additional relevant MeSH terms:
Psoriasis
Skin Diseases
Skin Diseases, Papulosquamous
Betamethasone
Betamethasone Valerate
Betamethasone benzoate
Betamethasone sodium phosphate
Betamethasone-17,21-dipropionate
Calcipotriene
Calcitriol
Anti-Asthmatic Agents
Anti-Inflammatory Agents
Bone Density Conservation Agents
Calcium Channel Agonists
Cardiovascular Agents
Dermatologic Agents
Glucocorticoids
Growth Substances
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Membrane Transport Modulators
Micronutrients
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Therapeutic Uses
Vasoconstrictor Agents
Vitamins

ClinicalTrials.gov processed this record on November 27, 2014