Effect of Topical Calcipotriene/Betamethasone (Taclonex) in Managing Localized Breakthrough in Moderate to Severe Plaque Psoriasis in Patients Receiving Efalizumab (Raptiva)
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
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). |
- 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) |
-
Drug: Calcipotriene/betamethasone
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 (Adult, Senior) |
| Genders Eligible for Study: | Both |
| 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.
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00608777
| United States, Kentucky | |
| DermResearch, PLLC | |
| Louisville, Kentucky, United States, 40217 | |
| Principal Investigator: | Leon H Kircik, M.D. | DermResearch, PLLC |
More Information
Publications:
| 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, 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 |
ClinicalTrials.gov processed this record on September 29, 2016