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| Sponsor: | Derm Research, PLLC |
|---|---|
| Collaborator: |
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 |
|---|---|---|
|
Plaque Psoriasis |
Drug: Calcipotriene/betamethasone |
Phase IV |
| 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). |
| 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) |
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Kentucky | |
| DermResearch, PLLC | |
| Louisville, Kentucky, United States, 40217 | |
| Principal Investigator: | Leon H Kircik, M.D. | DermResearch, PLLC |
More Information
| Responsible Party: | Leon Kircik, M.D., DermResearch, PLLC |
| ClinicalTrials.gov Identifier: | NCT00608777 History of Changes |
| Other Study ID Numbers: | ACD4311s |
| Study First Received: | January 23, 2008 |
| Last Updated: | March 9, 2009 |
| Health Authority: | United States: Institutional Review Board |
|
Localized mild breakthrough |
|
Psoriasis Skin Diseases, Papulosquamous Skin Diseases Betamethasone-17,21-dipropionate Betamethasone Betamethasone sodium phosphate Calcipotriene Calcitriol Anti-Inflammatory Agents Therapeutic Uses Pharmacologic Actions Anti-Asthmatic Agents Respiratory System Agents Glucocorticoids |
Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Dermatologic Agents Vitamins Micronutrients Growth Substances Bone Density Conservation Agents Calcium Channel Agonists Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Vasoconstrictor Agents Cardiovascular Agents |