A Placebo-Controlled Double-Blind Study on the Safety and Efficacy of Etanercept in Palmoplantar Pustulosis
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Tracking Information | |||||
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First Received Date ICMJE | July 14, 2006 | ||||
Last Updated Date | September 1, 2011 | ||||
Start Date ICMJE | April 2006 | ||||
Primary Completion Date | March 2007 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Percentage Change in Palmoplantar Pustulosis Severity Index (PPPASI) Before Crossover [ Time Frame: 12 weeks ] [ Designated as safety issue: No ] Comparison of the percentage change in Palmoplantar pustulosis severity index PPPASI) at 12 weeks in patients treated with placebo or etanercept PPPASI = (E + I + D)Area X 0.2 (R palm) + (E + I + D) Area X 0.2 (L palm) + (E + I + D) Area X 0.3 (R sole) + (E + I + D) Area X 0.3 (L sole). Erythema, pustules and desquamation are evaluated on a scale of 0 to 4 while area is evaluated on a scale of 0 to 6. The PPPASI score can vary from 0 (absence of disease) to 72 (most severe palmoplantar psoriasis possible). |
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Original Primary Outcome Measures ICMJE |
Comparison of the percentage change in Palmoplantar pustulosis severity index PPPASI) at 3 months in patients treated with placebo and etanercept | ||||
Change History | Complete list of historical versions of study NCT00353119 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | A Placebo-Controlled Double-Blind Study on the Safety and Efficacy of Etanercept in Palmoplantar Pustulosis | ||||
Official Title ICMJE | Phase 3 Study With a Placebo-Controlled, Double-blind, on the Safety and Efficacy of Etanercept in Palmo-Plantar Pustulosis | ||||
Brief Summary | Palmoplantar pustulosis (PPP) is a chronic recurrent skin condition characterized by the presence of pustules, erythema and hyperkeratosis on palms and soles. PPP can be a severe and disabling disease limiting the ability to walk or work. Although studies on the quality of life of patients with PPP are not available, a recent investigation showed that palmoplantar psoriasis (non pustular) has a more important impact on quality of life than plaque psoriasis. This important impact on quality of life is not surprising as palmoplantar psoriasis as well as palmoplantar pustulosis may limit the ability to work or conduct activities with hands or even impair walking. The disease is sometimes associated with psoriasis elsewhere on the body. Current treatments for PPP include topical corticosteroids, cyclosporine, PUVA therapy, methotrexate and acitretin. Response to topical corticosteroids and PUVA therapy is often disappointing presumably because the thickness of the stratum corneum on palms and soles prevents good penetration of topical medications and light. Cyclosporine and methotrexate are sometimes used with success for PPP but there are concerns with long term toxicity of both drugs. Therefore there is a need for new treatments for PPP. |
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Detailed Description | This is a placebo-controlled double blind study. Patients will be randomized to receive etanercept versus placebo in a 2:1 fashion for the first 3 months. All patients will receive etanercept in the last 3 months. Patients with active PPP will be included. A washout of 4 weeks for systemic medications and 2 weeks for Psoralen Ultra Violet A (PUVA) therapy will be required. A washout period of 2 weeks will be required for all other topical medications. The Palmoplantar pustulosis severity index (PPPASI) will be used to evaluate severity. Only patients with a severity score of 8 or more on hands and/or feet will be included. Safety will be assessed by performing physical examinations, evaluation of adverse events and biological parameters (complete blood count (CBC), chemistry, urinalysis). High quality digital medical photographs will be taken at baseline, 3 months and 6 months. |
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Study Type ICMJE | Interventional | ||||
Study Phase | Phase 3 | ||||
Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | Palmoplantaris Pustulosis | ||||
Intervention ICMJE |
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Study Arm (s) |
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Publications * | |||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Enrollment ICMJE | 15 | ||||
Completion Date | March 2007 | ||||
Primary Completion Date | March 2007 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | Canada | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT00353119 | ||||
Other Study ID Numbers ICMJE | 2.3 | ||||
Has Data Monitoring Committee | No | ||||
Responsible Party | Innovaderm Research Inc. | ||||
Study Sponsor ICMJE | Innovaderm Research Inc. | ||||
Collaborators ICMJE | Amgen | ||||
Investigators ICMJE |
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Information Provided By | Innovaderm Research Inc. | ||||
Verification Date | September 2011 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |