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

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.

Study Overview

• Status: Completed
• Conditions: Psoriasis; Palmoplantaris Pustulosis; Pustulosis of Palms and Soles; Pustular Psoriasis of Palms and Soles; Pustulosis Palmaris et Plantaris
• Intervention / Treatment: Drug: Alefacept

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 Type: Interventional
• Enrollment: 15
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6A 3H7
      • The Guenther Dermatology Research Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
percentage change in PPPASI from baseline

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

• Sponsor: The Guenther Dermatology Research Centre
• Collaborators: Biogen
• Investigators: Principal Investigator: Lyn C Guenther, MD, FRCPC, The Guenther Dermatology Research Centre

Study record dates

Study Major Dates

• Study Start: June 1, 2005
• Study Completion: October 1, 2006

Study Registration Dates

• First Submitted: March 8, 2006
• First Submitted That Met QC Criteria: March 8, 2006
• First Posted (Estimate): March 10, 2006

Study Record Updates

• Last Update Posted (Estimate): November 23, 2006
• Last Update Submitted That Met QC Criteria: November 21, 2006
• Last Verified: November 1, 2006

More Information

Terms related to this study

• Keywords: safety; effectiveness; Plantar; Alefacept; Palmar; Pustulosis
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Physiological Effects of Drugs; Immunologic Factors; Dermatologic Agents; Alefacept
• Other Study ID Numbers: IST 92