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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00820820 |
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Date of registration:
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09/01/2009 |
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Primary sponsor: |
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Public title:
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IDA (Immunothérapie de la Dermatite Atopique) Adult - Immunotherapy in Atopic Dermatitis
IDA-Adult |
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Scientific title:
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Immunotherapy of Atopic Dermatitis in Adult Patients by Anti-measles Vaccination IDA (Immunothérapie de la Dermatite Atopique)Protocol |
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Date of first enrolment:
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January 2009 |
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Target sample size:
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20 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00820820 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science
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Countries of recruitment
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France
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Contacts
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Name:
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Branka Horvat, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Institut National de la Santé Et de la Recherche Médicale, France |
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Key inclusion & exclusion criteria
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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).
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Atopic Dermatitis
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Intervention(s)
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Biological: placebo
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Biological: ROUVAX
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Primary Outcome(s)
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Effect of anti-measles vaccination on the T cell responses in patients
[Time Frame: 7 / 10 days after vaccine / placebo injection]
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Secondary Outcome(s)
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Biomarkers - E selectin, CD25, soluble CD30, CCL 17 and CCL 18
[Time Frame: 7 days, 14 days, 3 weeks after injection]
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blood level of measles specific IgE and antibodies
[Time Frame: 3 weeks after injection]
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Clinical evolution of AD, as measured by the SCORAD
[Time Frame: 3 weeks after injection]
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phenotypic characteristics of T lymphocytes
[Time Frame: 7 days, 14 days, 3 weeks, and 6 weeks after injection]
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Secondary ID(s)
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2007-007267-25
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C07-38
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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