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

History of Changes

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:

MedlinePlus related topics: Psoriasis

Drug Information available for: Betamethasone sodium phosphate Betamethasone Betamethasone valerate Betamethasone dipropionate Calcipotriene Daivobet

U.S. FDA Resources

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:

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:

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.

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.


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

ClinicalTrials.gov processed this record on February 27, 2015

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