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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-09

Study Completion Date

2012-03-26

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Atopic Dermatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Rouvax

Group Type ACTIVE_COMPARATOR

ROUVAX

Intervention Type BIOLOGICAL

Measles vaccine (ROUVAX ®), Schwarz strain (\>1000 DICC 50) in 0.5 ml of water for injection. One single subcutaneous injection.

Placebo

Sub cutaneous injection of vehicle

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type BIOLOGICAL

Vehicle (water for injection), 0.5 ml, once

Interventions

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ROUVAX

Measles vaccine (ROUVAX ®), Schwarz strain (\>1000 DICC 50) in 0.5 ml of water for injection. One single subcutaneous injection.

Intervention Type BIOLOGICAL

placebo

Vehicle (water for injection), 0.5 ml, once

Intervention Type BIOLOGICAL

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No