IDA Adult - Immunotherapy in Atopic Dermatitis - Full Text View

Sponsors and Collaborators:	Institut National de la Santé Et de la Recherche Médicale, France Ministry of Health, France
Information provided by:	Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier:	NCT00820820

Purpose

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.

Condition	Intervention
Atopic Dermatitis	Biological: ROUVAX Biological: placebo

MedlinePlus related topics: Measles

Drug Information available for: Measles Vaccine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Basic Science, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment
Official Title:	Immunotherapy of Atopic Dermatitis in Adult Patients by Anti-Measles Vaccination IDA Protocol

Further study details as provided by Institut National de la Santé Et de la Recherche Médicale, France:

Primary Outcome Measures:

Effect of anti-measles vaccination on the T cell responses in patients [ Time Frame: 7 / 10 days after vaccine / placebo injection ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Clinical evolution of AD, as measured by the SCORAD [ Time Frame: 3 weeks after injection ] [ Designated as safety issue: No ]
blood level of measles specific IgE and antibodies [ Time Frame: 3 weeks after injection ] [ Designated as safety issue: No ]
Biomarkers - E selectin, CD25, soluble CD30, CCL 17 and CCL 18 [ Time Frame: 7 days, 14 days, 3 weeks after injection ] [ Designated as safety issue: No ]
phenotypic characteristics of T lymphocytes [ Time Frame: 7 days, 14 days, 3 weeks, and 6 weeks after injection ] [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	January 2009
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Rouvax: Active Comparator	Biological: ROUVAX Measles vaccine (ROUVAX ®), Schwarz strain (>1000 DICC 50) in 0.5 ml of water for injection. One single subcutaneous injection.
Placebo: Placebo Comparator Sub cutaneous injection of vehicle	Biological: placebo Vehicle (water for injection), 0.5 ml, once

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

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00820820

Contacts

Contact: Catherine Cornu, MD

+33 4 72 35 72 31

catherine.cornu@chu-lyon.fr

Locations

France, Lyon
Unité de Recherche Clinique et Immunologique	Recruiting
Pierre-Bénite, Lyon, France, 69495
Contact: Catherine Goujon, MD +33 (0)4 78 86 41 25 catherine.goujon-henry@chu-lyon.fr
Principal Investigator: Catherine Goujon, MD

Sponsors and Collaborators

Institut National de la Santé Et de la Recherche Médicale, France

Ministry of Health, France

Investigators

Study Director:

Branka Horvat, MD, PhD

Institut National de la Santé Et de la Recherche Médicale, France

More Information

Responsible Party:	Hospices Civils de Lyon, France ( Catherine CORNU, MD, Doctor of the Lyon CLinical Investigation Centre )
Study ID Numbers:	N° EudraCT 2007-007267-25
Study First Received:	January 9, 2009
Last Updated:	January 9, 2009
ClinicalTrials.gov Identifier:	NCT00820820
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by Institut National de la Santé Et de la Recherche Médicale, France:

Atopic Dermatitis
immunosuppression
Measles vaccine
T lymphocytes
Atopic Dermatitis in adults

Study placed in the following topic categories:

Hypersensitivity
Dermatitis, Atopic
Genetic Diseases, Inborn
Skin Diseases
Measles

Hypersensitivity, Immediate
Skin Diseases, Eczematous
Skin Diseases, Genetic
Dermatitis

Additional relevant MeSH terms:

Immune System Diseases

ClinicalTrials.gov processed this record on January 16, 2009