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

Not Applicable

Completed

• Conditions: Atopic Dermatitis

• Registration Number: NCT00820820
• Lead Sponsor: Institut National de la Santé Et de la Recherche Médicale, France

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2009-01-09
• Study First Submitted: 2009-01-09
• Study First Submitted QC: 2009-01-09
• Study First Posted: 2009-01-12
• Primary Completion: 2012-03-26
• Study Completion: 2012-03-26
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-11
• Last Update Posted: 2020-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Effect of anti-measles vaccination on the T cell responses in patients	7 / 10 days after vaccine / placebo injection

Secondary Outcome Measures

Name	Time	Method
Clinical evolution of AD, as measured by the SCORAD	3 weeks after injection
blood level of measles specific IgE and antibodies	3 weeks after injection
Biomarkers - E selectin, CD25, soluble CD30, CCL 17 and CCL 18	7 days, 14 days, 3 weeks after injection
phenotypic characteristics of T lymphocytes	7 days, 14 days, 3 weeks, and 6 weeks after injection

Trial Locations

Locations (1)

Unité de Recherche Clinique et Immunologique; 🇫🇷 Pierre-Bénite, Lyon, France