Status:
COMPLETED
A Placebo-Controlled Double-Blind Study on the Safety and Efficacy of Etanercept in Palmoplantar Pustulosis
Lead Sponsor:
Innovaderm Research Inc.
Collaborating Sponsors:
Amgen
Conditions:
Palmoplantaris Pustulosis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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...
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 l...
Eligibility Criteria
Inclusion
- Palmoplantar pustulosis with a severity score of at least 8 on hands and-or feet
- Age 18 years or older
- Patient who would benefit from systemic therapy
- Unless surgically sterile (or at least 1 year post-menopausal for women) patients (heterosexual men and women) must have used a effective method of contraception for at least 30 days before the start of the study drug and until at least 1 month after the last drug administration
- Informed consent obtained
- Normal or non clinically significant chest X ray taken within 6 months of screening
- Negative serum pregnancy test at screening and negative urine pregnancy test at day 0 for women of childbearing potential
- Negative personal history of tuberculosis
- Presence of PPP for more than 6 months
- Subject must be willing to inject themselves subcutaneously.
- Negative PPD results
Exclusion
- Use of topical steroids, topical tar preparations, or other topical anti PPP or anti-psoriatic preparations within the past two weeks
- Unstable forms of psoriasis (acute guttate psoriasis, psoriatic erythroderma, generalized pustular psoriasis)
- At the investigator's discretion any significant infection within 30 days of screening or a patient at risk of septicemia
- Presence of acute forms of tinea pedis and other causes of pustular eruptions of the palms and soles apart from PPP based on clinical evaluation
- Evidence of any skin condition that would interfere with the evaluation of PPP
- Use of investigational drugs within the past four weeks
- Use of systemic anti-PPP or anti-psoriatic drugs such as steroids, retinoids, or methotrexate within the past four weeks
- Use of parenteral systemic antibiotics within the past four weeks
- Use of cyclosporine within the past four weeks
- Use of ultraviolet light therapy (UVB, nbUVB or PUVA) within the past two weeks
- An unstable or serious medical condition
- Known sero-positivity for the HIV virus
- Known hypersensitivity to etanercept or one of its components
- Receipt of live attenuated vaccines 12 weeks or less before Day 0 and during the course of the study
- Pregnant or breast feeding female subject
- Any significant medical condition that might cause this study to be detrimental to the patient
- At the investigator's discretion current or history of alcohol or drug abuse that would interfere with the ability to comply with the study protocol
- Presence of congestive heart failure
- Presence of a demyelinating disorder (optic neuritis, multiple sclerosis or other)
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2007
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00353119
Start Date
April 1 2006
End Date
March 1 2007
Last Update
September 9 2011
Active Locations (3)
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1
Innovaderm Research Incorporated
Laval, Quebec, Canada, H7S 2C6
2
Innovaderm Research Incorporated
Montreal, Quebec, Canada, H2K 4L5
3
Centre de Recherche Dermatologique du Québec métropolitain
Québec, Quebec, Canada, G1V 4X7