Effect of Topical Calcipotriene/Betamethasone (Taclonex) in Managing Localized Breakthrough in Moderate to Severe Plaque Psoriasis in Patients Receiving Efalizumab (Raptiva)
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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
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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 |
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 Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 6 participants |
Allocation: | N/A |
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 |
- 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
- 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 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

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
United States, Kentucky | |
DermResearch, PLLC | |
Louisville, Kentucky, United States, 40217 |
Principal Investigator: | Leon H Kircik, M.D. | DermResearch, PLLC |
Responsible Party: | Leon Kircik, M.D., Principal Investigator, Derm Research, PLLC |
ClinicalTrials.gov Identifier: | NCT00608777 |
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 |
Localized mild breakthrough |
Psoriasis Skin Diseases, Papulosquamous Skin Diseases Betamethasone Calcipotriene Anti-Inflammatory Agents Glucocorticoids |
Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Anti-Asthmatic Agents Respiratory System Agents Dermatologic Agents |