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

Atopic Dermatitis Clinical Trial

— IDA-Adult  

Official title:

Immunotherapy of Atopic Dermatitis in Adult Patients by Anti-measles Vaccination IDA (Immunothérapie de la Dermatite Atopique)Protocol

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00820820
• Other study ID #: C07-38
• Secondary ID: 2007-007267-25
• Status: Completed
• Phase: N/A
• Start date: January 9, 2009
• Est. completion date: March 26, 2012

Study information

• Verified date: February 2020
• Source: Institut National de la Santé Et de la Recherche Médicale, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 26, 2012
• Est. primary completion date: March 26, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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).

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Biological:
• ROUVAX
Measles vaccine (ROUVAX ®), Schwarz strain (>1000 DICC 50) in 0.5 ml of water for injection. One single subcutaneous injection.
• placebo
Vehicle (water for injection), 0.5 ml, once

Locations

Country	Name	City	State
France	Unité de Recherche Clinique et Immunologique	Pierre-Bénite	Lyon

Sponsors (2)

Lead Sponsor	Collaborator
Institut National de la Santé Et de la Recherche Médicale, France	Ministry of Health, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of anti-measles vaccination on the T cell responses in patients		7 / 10 days after vaccine / placebo injection
Secondary	Clinical evolution of AD, as measured by the SCORAD		3 weeks after injection
Secondary	blood level of measles specific IgE and antibodies		3 weeks after injection
Secondary	Biomarkers - E selectin, CD25, soluble CD30, CCL 17 and CCL 18		7 days, 14 days, 3 weeks after injection
Secondary	phenotypic characteristics of T lymphocytes		7 days, 14 days, 3 weeks, and 6 weeks after injection