- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00820820
IDA (Immunothérapie de la Dermatite Atopique) Adult - Immunotherapy in Atopic Dermatitis (IDA-Adult)
Immunotherapy of Atopic Dermatitis in Adult Patients by Anti-measles Vaccination IDA (Immunothérapie de la Dermatite Atopique)Protocol
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.
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Lyon
-
Pierre-Bénite, Lyon, France, 69495
- Unité de Recherche Clinique et Immunologique
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 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
|
Vehicle (water for injection), 0.5 ml, once
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Effect of anti-measles vaccination on the T cell responses in patients
Time Frame: 7 / 10 days after vaccine / placebo injection
|
7 / 10 days after vaccine / placebo injection
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Clinical evolution of AD, as measured by the SCORAD
Time Frame: 3 weeks after injection
|
3 weeks after injection
|
blood level of measles specific IgE and antibodies
Time Frame: 3 weeks after injection
|
3 weeks after injection
|
Biomarkers - E selectin, CD25, soluble CD30, CCL 17 and CCL 18
Time Frame: 7 days, 14 days, 3 weeks after injection
|
7 days, 14 days, 3 weeks after injection
|
phenotypic characteristics of T lymphocytes
Time Frame: 7 days, 14 days, 3 weeks, and 6 weeks after injection
|
7 days, 14 days, 3 weeks, and 6 weeks after injection
|
Collaborators and Investigators
Collaborators
Investigators
- Study Director: Branka Horvat, MD, PhD, Institut National de la Santé Et de la Recherche Médicale, France
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- C07-38
- 2007-007267-25 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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