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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. )
First Received: January 23, 2008   Last Updated: March 9, 2009   History of Changes
Sponsor: Derm Research, PLLC
Collaborator: Genentech
Information provided by: Derm Research, PLLC
ClinicalTrials.gov Identifier: NCT00608777
  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 IV

Study Type: Interventional
Study Design: Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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) on the PGA of LMB at week 2. [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. [ Time Frame: Four and six weeks. ] [ Designated as safety issue: No ]
  • The incidence of adverse events caused by calcipotriene/betamethasone (Taclonex) at weeks 2, 4 and 6. [ Time Frame: Weeks 2, 4 and 6 ] [ Designated as safety issue: Yes ]

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.
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
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
Investigators
Principal Investigator: Leon H Kircik, M.D. DermResearch, PLLC
  More Information

Publications:
Responsible Party: DermResearch, PLLC ( Leon Kircik, M.D. )
Study ID Numbers: ACD4311s
Study First Received: January 23, 2008
Last Updated: March 9, 2009
ClinicalTrials.gov Identifier: NCT00608777     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by Derm Research, PLLC:
Localized mild breakthrough

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

ClinicalTrials.gov processed this record on November 27, 2009