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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT00608777

Recruitment Status : Terminated (Withdrawal of marketing autorization of efalizumab by the EMEA.)

First Posted : February 6, 2008

Results First Posted : April 3, 2012

Last Update Posted : August 10, 2012

Sponsor:

Collaborator:

Genentech, Inc.

Information provided by (Responsible Party):

Leon Kircik, M.D., Derm Research, PLLC

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
Plaque Psoriasis	Drug: Calcipotriene/betamethasone	Phase 4

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.

Study Design


Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	6 participants
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).
Study Start Date :	January 2008
Actual Primary Completion Date :	February 2009
Actual Study Completion Date :	February 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

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

U.S. FDA Resources

Arms and Interventions

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

Outcome Measures

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 ]

Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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. Clin Dermatol. 1997 Sep-Oct;15(5):687-92. Review.

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.

Raptiva Prescribing Information. Genentech, Inc. June 2005

Taclonex Prescribing Information. Warner Chilcott (US), Inc. Jan 2006


Responsible Party:	Leon Kircik, M.D., Principal Investigator, Derm Research, PLLC
ClinicalTrials.gov Identifier:	NCT00608777 History of Changes
Other Study ID Numbers:	ACD4311s
First Posted:	February 6, 2008 Key Record Dates
Results First Posted:	April 3, 2012
Last Update Posted:	August 10, 2012
Last Verified:	August 2012

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


Localized mild breakthrough

Additional relevant MeSH terms:


Psoriasis Skin Diseases, Papulosquamous Skin Diseases Betamethasone benzoate Betamethasone-17,21-dipropionate Betamethasone Betamethasone Valerate Betamethasone sodium phosphate Calcipotriene Calcitriol Anti-Inflammatory Agents Glucocorticoids Hormones	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 Vitamins Micronutrients Growth Substances Bone Density Conservation Agents

To Top