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

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ClinicalTrials.gov Identifier: NCT00820820
Recruitment Status : Completed
First Posted : January 12, 2009
Last Update Posted : October 10, 2012
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Atopic Dermatitis Biological: ROUVAX Biological: placebo Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : January 2009
Actual Primary Completion Date : July 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema Measles
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Effect of anti-measles vaccination on the T cell responses in patients [ Time Frame: 7 / 10 days after vaccine / placebo injection ]

Secondary Outcome Measures :
  1. Clinical evolution of AD, as measured by the SCORAD [ Time Frame: 3 weeks after injection ]
  2. blood level of measles specific IgE and antibodies [ Time Frame: 3 weeks after injection ]
  3. Biomarkers - E selectin, CD25, soluble CD30, CCL 17 and CCL 18 [ Time Frame: 7 days, 14 days, 3 weeks after injection ]
  4. phenotypic characteristics of T lymphocytes [ Time Frame: 7 days, 14 days, 3 weeks, and 6 weeks after injection ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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 ( EudraCT Number )
First Posted: January 12, 2009    Key Record Dates
Last Update Posted: October 10, 2012
Last Verified: October 2012

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
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases