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Study to Evaluate the Efficacy of Alefacept to Treat Palmar Plantar Pustulosis

Primary Purpose

Psoriasis, Palmoplantaris Pustulosis, Pustular Psoriasis of Palms and Soles

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Alefacept
Sponsored by
The Guenther Dermatology Research Centre
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psoriasis focused on measuring safety, effectiveness, Alefacept, Palmar, Plantar, Pustulosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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. 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.

Sites / Locations

  • The Guenther Dermatology Research Centre

Outcomes

Primary Outcome Measures

percentage change in PPPASI from baseline

Secondary Outcome Measures

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

Full Information

First Posted
March 8, 2006
Last Updated
November 21, 2006
Sponsor
The Guenther Dermatology Research Centre
Collaborators
Biogen
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1. Study Identification

Unique Protocol Identification Number
NCT00301002
Brief Title
Study to Evaluate the Efficacy of Alefacept to Treat Palmar Plantar Pustulosis
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)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2006
Overall Recruitment Status
Completed
Study Start Date
June 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
The Guenther Dermatology Research Centre
Collaborators
Biogen

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
15 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Alefacept
Primary Outcome Measure Information:
Title
percentage change in PPPASI from baseline
Secondary Outcome Measure Information:
Title
number of subjects with PPPASI 75
Title
number of subjects with PPPASI 50
Title
number of subjects with very mild/clear PGA
Title
number of subjects with no pustules

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lyn C Guenther, MD, FRCPC
Organizational Affiliation
The Guenther Dermatology Research Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Guenther Dermatology Research Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 3H7
Country
Canada

12. IPD Sharing Statement

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Study to Evaluate the Efficacy of Alefacept to Treat Palmar Plantar Pustulosis

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