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 : February 12, 2020
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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 |
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 |
Actual Study Start Date : | January 9, 2009 |
Actual Primary Completion Date : | March 26, 2012 |
Actual Study Completion Date : | March 26, 2012 |

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 |
- Effect of anti-measles vaccination on the T cell responses in patients [ Time Frame: 7 / 10 days after vaccine / placebo injection ]
- Clinical evolution of AD, as measured by the SCORAD [ Time Frame: 3 weeks after injection ]
- blood level of measles specific IgE and antibodies [ Time Frame: 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 ]
- 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, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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).

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
France | |
Unité de Recherche Clinique et Immunologique | |
Pierre-Bénite, Lyon, France, 69495 |
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 |
Other Study ID Numbers: |
C07-38 2007-007267-25 ( EudraCT Number ) |
First Posted: | January 12, 2009 Key Record Dates |
Last Update Posted: | February 12, 2020 |
Last Verified: | February 2020 |
Atopic Dermatitis immunosuppression Measles vaccine T lymphocytes Atopic Dermatitis in adults |
Dermatitis, Atopic Dermatitis Eczema Skin Diseases Skin Diseases, Genetic |
Genetic Diseases, Inborn Skin Diseases, Eczematous Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |