Palmoplantaris PustulosisPhase 3NCT00353119
A Placebo-Controlled Double-Blind Study on the Safety and Efficacy of Etanercept in Palmoplantar Pustulosis
A Phase 3 study testing Etanercept in people with Palmoplantaris Pustulosis, run by Innovaderm Research Inc. at 3 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Palmoplantaris Pustulosis
- What is being tested?
- Etanercept
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 3 sitesCanada
- Study dates
- Apr 2006to Mar 2007
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Show all 19Show fewer
- 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)
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
Innovaderm Research Incorporated
Laval, Quebec, H7S 2C6
Innovaderm Research Incorporated
Montreal, Quebec, H2K 4L5
Centre de Recherche Dermatologique du Québec métropolitain
Québec, Quebec, G1V 4X7
About this study
Official title: Phase 3 Study With a Placebo-Controlled, Double-blind, on the Safety and Efficacy of Etanercept in Palmo-Plantar Pustulosis
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.
Read the 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.
- Conditions
- Palmoplantaris Pustulosis
- Being tested
- Placebo comparator, Etanercept
- Keywords
- Palmoplantar pustulosis, Psoriasis, Etanercept
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo comparatorDrug
Also called Saline
Patients received placebo subcutaneously twice weekly
EtanerceptDrug
Also called Enbrel
Patients received etanercept 50 mg subcutaneously twice weekly
| Study group | Role | What they receive |
|---|---|---|
| Placebo then etanercept | Placebo comparator | 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 Receives: Drug: Placebo comparator; Drug: Etanercept |
| Etanercept | Active comparator | Patients randomized to etanercept - Group 2. Patients received etanercept 50 mg subcutaneously twice weekly for 24 weeks Receives: Drug: Etanercept |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage Change in Palmoplantar Pustulosis Severity Index (PPPASI) Before Crossover
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).
Measured: 12 weeks
Secondary outcomes (3)
Number of Adverse Events
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.
Measured: 28 weeks
Percentage Change in Palmoplantar Pustulosis Area and Severity Index (PPPASI)
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).
Measured: 24 weeks
Percentage Change in Palmoplantar Pustulosis Area and Severity Index (PPPASI) After Crossover
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).
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2006 (estimated)
- Study startApr 2006
- Primary completionMar 2007
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Palmoplantaris PustulosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Innovaderm Research Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Amgen
- Responsible party
- Sponsor
- Investigators
- Robert Bissonnette, MD MSc FRCPC, Principal investigator, Innovaderm Research Incorporated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00353119
- Sponsor's protocol ID
- 2.3
- Status last verified
- Sep 2011
- First submitted
- 14 Jul 2006
- Last updated
- 9 Sep 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3 Study With a Placebo-Controlled, Double-blind, on the Safety and Efficacy of Etanercept in Palmo-Plantar Pustulosis
- ClinicalTrials.gov ID
- NCT00353119
- Acronym / sponsor ID
- 2.3
- Conditions
- Palmoplantaris Pustulosis
- Keywords
- Palmoplantar pustulosis, Psoriasis, Etanercept
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Innovaderm Research Inc.University, hospital or other
- Collaborators
- Amgen
- Study start
- Apr 2006
- Primary completion
- Mar 2007 (actual)
- Study completion
- Mar 2007 (actual)
- First posted
- 17 Jul 2006 (estimated)
- Results
- Posted 21 Dec 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo then etanercept | Placebo comparator | Drug: Placebo comparator, Drug: EtanerceptPatients 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 |
| Etanercept | Active comparator | Drug: EtanerceptPatients randomized to etanercept - Group 2. Patients received etanercept 50 mg subcutaneously twice weekly for 24 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo comparatorAlso: SalinePatients received placebo subcutaneously twice weekly | Drug | Placebo then etanercept |
| EtanerceptAlso: EnbrelPatients received etanercept 50 mg subcutaneously twice weekly | Drug | Etanercept, Placebo then etanercept |
Primary outcome
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).
3 secondary outcomes
Number of Adverse Events
Time frame: 28 weeks
Percentage Change in Palmoplantar Pustulosis Area and Severity Index (PPPASI)
Time frame: 24 weeks
Percentage Change in Palmoplantar Pustulosis Area and Severity Index (PPPASI) After Crossover
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Bissonnette, MD MSc FRCPC principal investigator
Innovaderm Research Incorporated
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Etanercept in people with Palmoplantaris Pustulosis, run by Innovaderm Research Inc. at 3 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Dec 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage Change in Palmoplantar Pustulosis Severity Index (PPPASI) Before Crossover (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2011.