A Placebo-Controlled Double-Blind Study on the Safety and Efficacy of Etanercept in Palmo-Plantar Pustulosis - Full Text View

Sponsors and Collaborators:	Innovaderm Research Inc. Amgen
Information provided by:	Innovaderm Research Inc.
ClinicalTrials.gov Identifier:	NCT00353119

Purpose

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 palmo-plantar 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 palmo-plantar 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.

Condition	Intervention	Phase
Palmoplantaris Pustulosis	Drug: Etanercept Drug: Placebo comparator	Phase III

MedlinePlus related topics: Psoriasis

Drug Information available for: Etanercept

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Phase 3 Study With a Placebo-Controlled, Double-Blind, on the Safety and Efficacy of Etanercept in Palmo-Plantar Pustulosis

Further study details as provided by Innovaderm Research Inc.:

Primary Outcome Measures:

Comparison of the percentage change in Palmoplantar pustulosis severity index PPPASI) at 3 months in patients treated with placebo and etanercept [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Study the safety of etanercept in patients with PPP [ Time Frame: 28 weeks ] [ Designated as safety issue: Yes ]
Evaluate efficacy using PPPASI in patient with PPP treated with etanercept for 6 months [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Enrollment:	15
Study Start Date:	April 2006
Study Completion Date:	March 2007
Primary Completion Date:	March 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Placebo Comparator Patients randomized to initiate the study with placebo	Drug: Placebo comparator Patients received placebo for the first 12 weeks and crossed over to etanercept for weeks 12 to 24
2: Active Comparator Patients randomized to etanercept	Drug: Etanercept Patients received etanercept 50 mg SC twice weekly for 24 weeks

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 PUVA therapy will be required. A washout period of 2 weeks will be required for all other topical medications. The Palmo-plantar pustulosis severity index (PPPASI) will be used to evaluate severity (1). 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 (CBC, chemistry, urinalysis).

High quality digital medical photographs will be taken at baseline, 3 months and 6 months.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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 Criteria:

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, MS or other)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00353119

Locations

Canada
Centre de Recherche Dermatologique du Québec métropolitain
Quebec, Canada, G1V 4X7
Canada, Quebec
Innovaderm Research Incorporated
Montreal, Quebec, Canada, H2K 4L5
Innovaderm Research Incorporated
Laval, Quebec, Canada, H7S 2C6

Sponsors and Collaborators

Innovaderm Research Inc.

Amgen

Investigators

Principal Investigator:

Robert Bissonnette, MD MSc FRCPC

Innovaderm Research Incorporated

More Information

No publications provided

Responsible Party:	Innovaderm Research Inc. ( Robert Bissonnette, MD FRCPC )
Study ID Numbers:	2.3
Study First Received:	July 14, 2006
Last Updated:	May 7, 2008
ClinicalTrials.gov Identifier:	NCT00353119 History of Changes
Health Authority:	Canada: Health Canada

Keywords provided by Innovaderm Research Inc.:

Palmoplantar pustulosis
Psoriasis
Etanercept

Study placed in the following topic categories:

Anti-Inflammatory Agents
Immunologic Factors
Skin Diseases
Analgesics, Non-Narcotic
Psoriasis
Anti-Inflammatory Agents, Non-Steroidal

Peripheral Nervous System Agents
Analgesics
Antirheumatic Agents
TNFR-Fc fusion protein
Immunosuppressive Agents
Skin Diseases, Papulosquamous

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Immunologic Factors
Skin Diseases
Physiological Effects of Drugs
Gastrointestinal Agents
TNFR-Fc fusion protein
Immunosuppressive Agents
Pharmacologic Actions
Psoriasis

Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents
Skin Diseases, Papulosquamous

ClinicalTrials.gov processed this record on May 07, 2009