Clinical trial NCT00820820: IDA (Immunothérapie de la Dermatite Atopique) Adult - Immunotherapy in Atopic Dermatitis
Official title: Immunotherapy of Atopic Dermatitis in Adult Patients by Anti-measles Vaccination IDA (Immunothérapie de la Dermatite Atopique)Protocol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atopic Dermatitis
Keywords: Atopic Dermatitis
immunosuppression
Measles vaccine
T lymphocytes
Atopic Dermatitis in adults
Lead sponsor: Institut National de la Santé Et de la Recherche Médicale, France
Sponsor class: OTHER_GOV
Collaborators: name: Ministry of Health, France
First posted: 2009-01-12
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Effect of anti-measles vaccination on the T cell responses in patients
timeFrame: 7 / 10 days after vaccine / placebo injection
Secondary outcomes:
measure: Clinical evolution of AD, as measured by the SCORAD
timeFrame: 3 weeks after injection
measure: blood level of measles specific IgE and antibodies
timeFrame: 3 weeks after injection
measure: Biomarkers - E selectin, CD25, soluble CD30, CCL 17 and CCL 18
timeFrame: 7 days, 14 days, 3 weeks after injection
measure: phenotypic characteristics of T lymphocytes
timeFrame: 7 days, 14 days, 3 weeks, and 6 weeks after injection
Other outcomes:
Locations:
city: Pierre-Bénite
country: France
facility: Unité de Recherche Clinique et Immunologique
state: Lyon
Study officials:
affiliation: Institut National de la Santé Et de la Recherche Médicale, France
name: Branka Horvat, MD, PhD
role: STUDY_DIRECTOR
References: