IDA (Immunothérapie de la Dermatite Atopique) Adult - Immunotherapy in Atopic Dermatitis

N/ACompletedNCT00820820

Institut National de la Santé Et de la Recherche Médicale, France20 enrolled

Overview

Atopic dermatitis (AD) is a chronic inflammatory disease of the skin. AD is very frequent, and involves T lymphocytes cells. Measles vaccination, as well as measles vaccine, induces a temporary immunosuppression; furthermore, an improvement of AD has been observed during measles infection. This trial is aimed at demonstrating that measles vaccine is able to create an immunomodulation and to improve AD symptoms. 30 adult patients of both sexes with moderate to severe AD will be randomly assigned to measles vaccine (ROUVAX ®), or placebo (vehicle) and follow-up for 45 days. The primary outcome is the effect of anti-measles vaccination on the T cell responses in patients; Other outcomes include: clinical evolution of AD, as measured by the SCORAD, the evolution of blood level of measles specific IgE and antibodies; evolution of other biomarkers and phenotypic characteristics of T lymphocytes.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

QUADRUPLE

Enrollment

Conditions

Atopic Dermatitis

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * adults patients of both sexes, with moderate to severe Atopic Dermatitis (SCORAD (Score for Atopic Dermatitis) ≥ 15). Exclusion Criteria: * hypersensititvity or contra-indication to a Rouvax® component, Tubertest® component, to egg proteins, immunological deficiency, pregnancy, neomycin * allergy, * systemic immnosuppressive treatment in the previous 3 months, * topic immunosuppressive treatment during the week preceeding the inclusion (gluco-corticoid, or immunosuppressive agent), * fever or acute disease (the inclusion must be postpone in such cases).

Outcomes

Primary Outcomes

Effect of anti-measles vaccination on the T cell responses in patients

Time frame: 7 / 10 days after vaccine / placebo injection

Secondary Outcomes

Clinical evolution of AD, as measured by the SCORAD

Time frame: 3 weeks after injection

blood level of measles specific IgE and antibodies

Time frame: 3 weeks after injection

Biomarkers - E selectin, CD25, soluble CD30, CCL 17 and CCL 18

Time frame: 7 days, 14 days, 3 weeks after injection

phenotypic characteristics of T lymphocytes

Time frame: 7 days, 14 days, 3 weeks, and 6 weeks after injection