Ignite Creation Date:
2024-05-05 @ 4:56 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00353119
Status:
COMPLETED
Last Update Posted:
2011-09-09
First Post:
2006-07-14
Brief Title:
A Placebo-Controlled Double-Blind Study on the Safety and Efficacy of Etanercept in Palmoplantar Pustulosis
Sponsor:
Innovaderm Research Inc
Organization:
Innovaderm Research Inc
Study Overview
Official Title:
Phase 3 Study With a Placebo-Controlled Double-blind on the Safety and Efficacy of Etanercept in Palmo-Plantar Pustulosis
Status:
COMPLETED
Status Verified Date:
2011-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
This is a placebo-controlled double blind study Patients will be randomized to receive etanercept versus placebo in a 21 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 andor 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
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 andor 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None