PsoriasisPhase 2NCT00301002
Study to Evaluate the Efficacy of Alefacept to Treat Palmar Plantar Pustulosis
A Phase 2 study testing Alefacept in people with Psoriasis and Palmoplantaris Pustulosis, run by The Guenther Dermatology Research Centre at 1 site in Canada.
Trial summary
The purpose of this study is to determine if Alefacept is effective in the treatment of palmar plantar pustulosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis, Palmoplantaris Pustulosis, Pustular Psoriasis of Palms and Soles
- What is being tested?
- Alefacept
- How many people
- 15 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2005to Oct 2006
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Subjects must have stable, moderate, severe or very severe palmar plantar pustulosis.
- Must have a minimum of at least 3 pustules on 1 sole or palm.
- Must give written informed consent.
- Subjects must be 18 years of age or older.
- Adult Males and non-pregnant, non-lactating females.
- Female subjects of childbearing potential must state that they are using measures to avoid conception through active means.
- Subjects must be in general good health with no other skin disease, disease state or physical condition which would impair evaluation of palmar plantar pustulosis or which would increase their health risk by study participation.
- Subjects must be willing to receive a 15 mg IM injection of Alefacept weekly for 16 weeks.
Who cannot join
- Female subjects who are not postmenopausal for at least 1 year, surgically sterile, or willing to practice effective contraception during the study. Nursing mothers, pregnant women and women planning to become pregnant while on study are to be excluded.
- Current enrollment in any investigational study in which the subject is receiving any type of drug, biologic, or non-drug therapy.
- Serious local infection (e.g., cellulitis, abscess) or systemic infection (e.g., pneumonia, septicemia) within the 3 months prior to the first dose of investigational drug.
- Any subject whose CD4+ T-lymphocyte count at study entry is less than the lower limit of normal per reference laboratory.
- Treatment with another investigational drug or approved therapy for investigational use within 28 days prior to investigational drug administration.
- Treatment with psoralen + ultraviolet A (PUVA), systemic retinoids, systemic steroids, methotrexate, cyclosporine, azathioprine, thioguanine, etanercept, efalizumab, infliximab, adalimumab or mofetil or other systemic immunosuppressant agents within the 28 days prior to investigational drug administration.
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- Ultraviolet B (UVB) phototherapy within 14 days prior to investigational drug administration.
- Treatment within 7 days with topical agents (e.g. tar, anthralin, calcipotriol, tazarotene, steroids) which might have an effect on palmar plantar pustulosis.
- Known HIV, Hepatitis B or C seropositivity or tuberculosis infection.
- Significant abnormal chemistry, i.e. liver function tests greater than 3 times the upper limit of normal.
- Allergy to Alefacept or any of the components of the formulation.
- Known malignancy or history of malignancy within the previous 5 years (with the exception of basal cell carcinoma of the skin or squamous cell carcinoma in situ of the skin that has been treated with no evidence of recurrence.)
- Previous treatment with alefacept.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Open-Label Study to Evaluate the Safety and Observe the Effectiveness of 16 Weeks of Alefacept in Palmar Plantar Pustulosis (IST 92)
The purpose of this study is to determine if Alefacept is effective in the treatment of palmar plantar pustulosis.
Read the detailed description
Palmar plantar pustulosis is a chronic, disabling skin condition which is difficult to treat since it is often recalcitrant to current treatments and associated with high recurrence rates. This condition appears to be a T lymphocyte mediated condition and is thought by some to be a subtype of psoriasis. Alefacept affects T cell activation and induces apoptosis of memory T cells. It has been shown to be efficacious in the treatment of psoriasis vulgaris and may be associated with prolonged remissions. There is extremely limited experience with use of Alefacept in Palmar Plantar Pustulosis. This pilot trial should provide additional information concerning its use for this indication.
- Conditions
- Psoriasis, Palmoplantaris Pustulosis, Pustular Psoriasis of Palms and Soles, Pustulosis Palmaris et Plantaris, Pustulosis of Palms and Soles
- Being tested
- Alefacept
- Keywords
- safety, effectiveness, Alefacept, Palmar, Plantar, Pustulosis
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlefaceptDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage change in PPPASI from baseline
Secondary outcomes (4)
number of subjects with PPPASI 75
number of subjects with PPPASI 50
number of subjects with very mild/clear PGA
number of subjects with no pustules
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2006 (estimated)
- Study startJun 2005
- Study completionOct 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants
Sponsor and investigators
- Lead sponsor
- The Guenther Dermatology Research Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Biogen
- Investigators
- Lyn C Guenther, MD, FRCPC, Principal investigator, The Guenther Dermatology Research Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00301002
- Sponsor's protocol ID
- IST 92
- Status last verified
- Nov 2006
- First submitted
- 8 Mar 2006
- Last updated
- 23 Nov 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Open-Label Study to Evaluate the Safety and Observe the Effectiveness of 16 Weeks of Alefacept in Palmar Plantar Pustulosis (IST 92)
- ClinicalTrials.gov ID
- NCT00301002
- Acronym / sponsor ID
- IST 92
- Conditions
- Psoriasis, Palmoplantaris Pustulosis, Pustular Psoriasis of Palms and Soles, Pustulosis Palmaris et Plantaris, Pustulosis of Palms and Soles
- Keywords
- safety, effectiveness, Alefacept, Palmar, Plantar, Pustulosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants
- Lead sponsor
- The Guenther Dermatology Research CentreUniversity, hospital or other
- Collaborators
- Biogen
- Study start
- Jun 2005
- Study completion
- Oct 2006
- First posted
- 10 Mar 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if Alefacept is effective in the treatment of palmar plantar pustulosis.
Detailed description
Palmar plantar pustulosis is a chronic, disabling skin condition which is difficult to treat since it is often recalcitrant to current treatments and associated with high recurrence rates. This condition appears to be a T lymphocyte mediated condition and is thought by some to be a subtype of psoriasis. Alefacept affects T cell activation and induces apoptosis of memory T cells. It has been shown to be efficacious in the treatment of psoriasis vulgaris and may be associated with prolonged remissions. There is extremely limited experience with use of Alefacept in Palmar Plantar Pustulosis. This pilot trial should provide additional information concerning its use for this indication.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subjects must have stable, moderate, severe or very severe palmar plantar pustulosis.
- Must have a minimum of at least 3 pustules on 1 sole or palm.
- Must give written informed consent.
- Subjects must be 18 years of age or older.
- Adult Males and non-pregnant, non-lactating females.
Key exclusion criteria (13 listed)
- Female subjects who are not postmenopausal for at least 1 year, surgically sterile, or willing to practice effective contraception during the study. Nursing mothers, pregnant women and women planning to become pregnant while on study are to be excluded.
- Current enrollment in any investigational study in which the subject is receiving any type of drug, biologic, or non-drug therapy.
- Serious local infection (e.g., cellulitis, abscess) or systemic infection (e.g., pneumonia, septicemia) within the 3 months prior to the first dose of investigational drug.
- Any subject whose CD4+ T-lymphocyte count at study entry is less than the lower limit of normal per reference laboratory.
- Treatment with another investigational drug or approved therapy for investigational use within 28 days prior to investigational drug administration.
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 |
|---|---|---|
| Alefacept | Drug | – |
Primary outcome
percentage change in PPPASI from baseline
4 secondary outcomes
number of subjects with PPPASI 75
number of subjects with PPPASI 50
number of subjects with very mild/clear PGA
number of subjects with no pustules
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2006.
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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.
Lyn C Guenther, MD, FRCPC principal investigator
The Guenther Dermatology Research Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Alefacept in people with Psoriasis and Palmoplantaris Pustulosis, run by The Guenther Dermatology Research Centre at 1 site 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 8 inclusion and 13 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 23 Nov 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 PPPASI from baseline. 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 23 Nov 2006.