Plaque Psoriasis
Conditions
Keywords
Localized mild breakthrough
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.
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.
Interventions
DRUGCalcipotriene/betamethasone
One application to affected areas, once a day for two weeks. The PI may choose to extend treatment until Week 4 if necessary.
Sponsors
Genentech, Inc.
Derm Research, PLLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Proportion of Subjects Who Acheive a Score of Clear (0) or Almost Clear (1) on the PGA of LMB at Week 2 | week 2 |
Countries
United States
Participant flow
Recruitment details
Recruitment from January 2008 through December 2008. Subjects recruited from physician data base.
Pre-assignment details
Subjects experiencing mild localized breakthrough associated with Raptiva use were recruited.
Participants by arm
| Arm | Count |
|---|---|
| Open Label Taclonex | 6 |
| Total | 6 |
Baseline characteristics
| Characteristic | Open Label Taclonex |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants |
| Region of Enrollment United States | 6 participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 6 |
| serious Total, serious adverse events | 0 / 6 |
Outcome results
Primary
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