CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 15 enrolled
Drug / intervention
Placebo comparator +1 moredrug
Likely dose
Etanercept 50 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00353119
NCT00353119Phase 3Completed

Phase 3 Study With a Placebo-Controlled, Double-blind, on the Safety and Efficacy of Etanercept in Palmo-Plantar Pustulosis

Innovaderm Research Inc.·interventional·Posted Jul 17, 2006·Updated Sep 9, 2011

In Brief

A Phase 3 clinical trial evaluating Placebo comparator and Etanercept for Palmoplantaris Pustulosis. Completed, enrolled 15 participants across 3 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada
CollaboratorsAmgen

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 17, 2006
Enrollment StartApr 1, 2006
Primary CompletionMar 1, 2007
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 20.0 years ago

Interventions

Placebo comparatordrug

Patients received placebo subcutaneously twice weekly

Etanerceptdrug

Patients received etanercept 50 mg subcutaneously twice weekly