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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 is currently recruiting participants.
Verified by Derm Research, PLLC, January 2008

Sponsors and Collaborators: Derm Research, PLLC
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
Localized Mild Breakthrough
Plaque Psoriasis
Drug: Calcipotriene/betamethasone
Phase IV

MedlinePlus related topics:   Psoriasis   

Drug Information available for:   Calcipotriene    Efalizumab    Betamethasone    Bentelan    Betamethasone dipropionate   

U.S. FDA Resources

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).

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 ]

Estimated Enrollment:   15
Study Start Date:   January 2008
Estimated Study Completion Date:   July 2008
Estimated Primary Completion Date:   July 2008 (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

Contacts
Contact: Leon H Kircik, M.D.     502-451-9000     wedoderm@bellsouth.net    
Contact: Deborah B Zuidema, M.S.N.     502-456-4161     wedoderm@bellsouth.net    

Locations
United States, Kentucky
DermResearch, PLLC     Recruiting
      Louisville, Kentucky, United States, 40217
      Contact: Leon H Kircik, M.D.     502-451-9000     wedoderm@bellsouth.net    
      Contact: Deborah B Zuidema, M.S.N.     502-456-4161     wedoderm@bellsouth.net    
      Principal Investigator: Leon H Kircik, M.D.            

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
First Received:   January 23, 2008
Last Updated:   January 23, 2008
ClinicalTrials.gov Identifier:   NCT00608777
Health Authority:   United States: Institutional Review Board

Study placed in the following topic categories:
Calcipotriene
Betamethasone-17,21-dipropionate
Sodium phosphate
Skin Diseases
Psoriasis
Betamethasone sodium phosphate
Betamethasone
Skin Diseases, Papulosquamous

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Respiratory System Agents
Therapeutic Uses
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Asthmatic Agents
Dermatologic Agents
Hormones
Glucocorticoids
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 03, 2008




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