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Trial record 4 of 16 for:    "Pustulosis Palmaris Et Plantaris"

A Placebo-Controlled Double-Blind Study on the Safety and Efficacy of Etanercept in Palmoplantar Pustulosis

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ClinicalTrials.gov Identifier: NCT00353119
Recruitment Status : Completed
First Posted : July 17, 2006
Results First Posted : December 21, 2010
Last Update Posted : September 9, 2011
Sponsor:
Collaborator:
Amgen
Information provided by (Responsible Party):
Innovaderm Research Inc.

Tracking Information
First Submitted Date  ICMJE July 14, 2006
First Posted Date  ICMJE July 17, 2006
Results First Submitted Date  ICMJE November 23, 2010
Results First Posted Date  ICMJE December 21, 2010
Last Update Posted Date September 9, 2011
Study Start Date  ICMJE April 2006
Actual Primary Completion Date March 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 23, 2010)
Percentage Change in Palmoplantar Pustulosis Severity Index (PPPASI) Before Crossover [ Time Frame: 12 weeks ]
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).
Original Primary Outcome Measures  ICMJE
 (submitted: July 14, 2006)
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
 (submitted: November 23, 2010)
  • Number of Adverse Events [ Time Frame: 28 weeks ]
    Study the safety of etanercept in patients with PPP by collecting adverse events from the screening visit until week 28. For a given AE, a subject will be counted once even if he or she has experienced multiple episodes for that particular AE. An adverse event is any untoward medical occurrence including any clinically significant abnormal laboratory values or variation from the baseline condition to the last visit (week 28) in a patient receiving a pharmaceutical product, without regards to the possibility of a causal relationship with this treatment.
  • Percentage Change in Palmoplantar Pustulosis Area and Severity Index (PPPASI) [ Time Frame: 24 weeks ]
    Evaluate efficacy using palmoplantar pustulosis area and severity index (PPPASI) in patient with palmoplantar pustulosis treated with etanercept for 6 months 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).
  • Percentage Change in Palmoplantar Pustulosis Area and Severity Index (PPPASI) After Crossover [ Time Frame: 12 weeks ]
    Evaluate efficacy using palmoplantar pustulosis area and severity index (PPPASI) in patient with palmoplantar pustulosis treated with etanercept for 6 months 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).
Original Secondary Outcome Measures  ICMJE
 (submitted: July 14, 2006)
  • Study the safety of etanercept in patients with PPP
  • Evaluate efficacy using PPPASI in patient with PPP treated with etanercept for 6 months
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Palmoplantaris Pustulosis
Intervention  ICMJE
  • Drug: Placebo comparator
    Patients received placebo subcutaneously twice weekly
    Other Name: Saline
  • Drug: Etanercept
    Patients received etanercept 50 mg subcutaneously twice weekly
    Other Name: Enbrel
Study Arms  ICMJE
  • Placebo Comparator: Placebo then etanercept
    Patients randomized to initiate the study with placebo for the first 12 weeks - Group 1 then crossed over to etanercept 50mg twice weekly for weeks 12 to 24
    Interventions:
    • Drug: Placebo comparator
    • Drug: Etanercept
  • Active Comparator: Etanercept
    Patients randomized to etanercept - Group 2. Patients received etanercept 50 mg subcutaneously twice weekly for 24 weeks
    Intervention: Drug: Etanercept
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 14, 2006)
15
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2007
Actual Primary Completion Date March 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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, multiple sclerosis or other)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00353119
Other Study ID Numbers  ICMJE 2.3
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Innovaderm Research Inc.
Study Sponsor  ICMJE Innovaderm Research Inc.
Collaborators  ICMJE Amgen
Investigators  ICMJE
Principal Investigator: Robert Bissonnette, MD MSc FRCPC Innovaderm Research Incorporated
PRS Account 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