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

This study has been completed.
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by (Responsible Party):
Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier:
NCT00820820
First received: January 9, 2009
Last updated: October 8, 2012
Last verified: October 2012
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Immunotherapy of Atopic Dermatitis in Adult Patients by Anti-measles Vaccination IDA (Immunothérapie de la Dermatite Atopique)Protocol

Resource links provided by NLM:


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 ]

Enrollment: 20
Study Start Date: January 2009
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Rouvax Biological: ROUVAX
Measles vaccine (ROUVAX ®), Schwarz strain (>1000 DICC 50) in 0.5 ml of water for injection. One single subcutaneous injection.
Placebo Comparator: Placebo
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

Locations
France
Unité de Recherche Clinique et Immunologique
Pierre-Bénite, Lyon, France, 69495
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

No publications provided

Responsible Party: Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier: NCT00820820     History of Changes
Other Study ID Numbers: C07-38, 2007-007267-25
Study First Received: January 9, 2009
Last Updated: October 8, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on April 17, 2014