Efalizumab for Eczema

U

University of Medicine and Dentistry of New Jersey

Status and phase

Completed
Phase 2

Conditions

Dermatitis, Atopic

Treatments

Drug: Efalizumab treatment

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT00146003
5163

Details and patient eligibility

About

The purpose of this study is to demonstrate a measurable improvement on a validated scale in a small population of adult patients with atopic dermatitis (eczema).

Full description

The study involves administration of efalizumab (previously approved for psoriasis) to ten adult patients with atopic dermatitis. Biologic plausibility rests on similarities in pathophysiology of the two conditions. The drug (efalizumab) will be administered according to the dosing approved for plaque psoriasis for a period of 24 weeks. The subjects will self-administer efalizumab weekly and measurements will be performed on a monthly basis. Efalizumab is not being compared to placebo or other drugs.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Adults (18 years or older) with atopic dermatitis with 5% or more body surface area involvement
  • Investigator Global Assessment (IGA) score of "moderate" or worse
  • In general good health with well-controlled medical problems
  • Ability to provide written informed consent and comply with study assessments for the full duration of the study.
  • If a female of childbearing potential, a negative pregnancy test and commitment to the use of two forms of effective contraception (birth control) for the duration of the study are necessary.
  • If a non-sterile male, commitment to the use of two forms of effective contraception (birth control) for the duration of the study is necessary.
  • Normal platelet count

Exclusion criteria

  • Patients with known hypersensitivity to efalizumab or any of its components
  • Pregnancy or lactation
  • Patients receiving immunosuppressive agents
  • Prior enrollment in the study
  • Participation in another simultaneous medical investigation or trial
  • IGA score of "mild," "almost clear" or "clear"
  • Systemic therapy for atopic dermatitis, phototherapy or topical therapy (other than moisturizer) within 1 week
  • Medical condition which would make use of efalizumab unsafe; would limit compliance with study requirements; or would limit accurate assessment of efficacy.
  • Ongoing, active, serious infection
  • History of malignancy (except excised basal or squamous cell carcinoma of the skin)

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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