Atopic DermatitisIDA-AdultNCT00820820
IDA (Immunothérapie de la Dermatite Atopique) Adult - Immunotherapy in Atopic Dermatitis
A study testing ROUVAX in people with Atopic Dermatitis, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- ROUVAX
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 9 Jan 2009to 26 Mar 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adults patients of both sexes, with moderate to severe Atopic Dermatitis (SCORAD (Score for Atopic Dermatitis) ≥ 15).
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
France1 site
Unité de Recherche Clinique et Immunologique
Pierre-Bénite, Lyon, 69495
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Atopic Dermatitis
- Being tested
- ROUVAX, placebo
- Keywords
- Atopic Dermatitis, immunosuppression, Measles vaccine, T lymphocytes, Atopic Dermatitis in adults
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ROUVAXBiological
Measles vaccine (ROUVAX ®), Schwarz strain (>1000 DICC 50) in 0.5 ml of water for injection. One single subcutaneous injection.
placeboBiological
Vehicle (water for injection), 0.5 ml, once
| Study group | Role | What they receive |
|---|---|---|
| Rouvax | Active comparator | Not described Receives: Biological: ROUVAX |
| Placebo | Placebo comparator | Sub cutaneous injection of vehicle Receives: Biological: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of anti-measles vaccination on the T cell responses in patients
Measured: 7 / 10 days after vaccine / placebo injection
Secondary outcomes (4)
Clinical evolution of AD, as measured by the SCORAD
Measured: 3 weeks after injection
blood level of measles specific IgE and antibodies
Measured: 3 weeks after injection
Biomarkers - E selectin, CD25, soluble CD30, CCL 17 and CCL 18
Measured: 7 days, 14 days, 3 weeks after injection
phenotypic characteristics of T lymphocytes
Measured: 7 days, 14 days, 3 weeks, and 6 weeks after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2009 (estimated)
- Study start9 Jan 2009
- Primary completion26 Mar 2012
- Study completion26 Mar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Sponsor type
- Other government
- Collaborators
- Ministry of Health, France
- Responsible party
- Sponsor
- Investigators
- Branka Horvat, MD, PhD, Study director, Institut National de la Santé Et de la Recherche Médicale, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00820820
- Sponsor's protocol ID
- C07-38
- Other IDs
- 2007-007267-25
- Acronym
- IDA-Adult
- Status last verified
- Feb 2020
- First submitted
- 9 Jan 2009
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Gourru-Lesimple G, Mathieu C, Thevenet T, Guillaume-Vasselin V, Jegou JF, Boer CG, Tomczak K, Bloyet LM, Giraud C, Grande S, Goujon C, Cornu C, Horvat B. Measles virus infection of human keratinocytes: Possible link between measles and atopic dermatitis. J Dermatol Sci. 2017 May;86(2):97-105. doi: 10.1016/j.jdermsci.2017.01.015. Epub 2017 Feb 10.
PubMed 28233587
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunotherapy of Atopic Dermatitis in Adult Patients by Anti-measles Vaccination IDA (Immunothérapie de la Dermatite Atopique)Protocol
- ClinicalTrials.gov ID
- NCT00820820
- Acronym / sponsor ID
- IDA-Adult / C07-38
- Conditions
- Atopic Dermatitis
- Keywords
- Atopic Dermatitis, immunosuppression, Measles vaccine, T lymphocytes, Atopic Dermatitis in adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, FranceOther government
- Collaborators
- Ministry of Health, France
- Study start
- 9 Jan 2009 (actual)
- Primary completion
- 26 Mar 2012 (actual)
- Study completion
- 26 Mar 2012 (actual)
- First posted
- 12 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rouvax | Active comparator | Biological: ROUVAX |
| Placebo | Placebo comparator | Biological: placeboSub cutaneous injection of vehicle |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- adults patients of both sexes, with moderate to severe Atopic Dermatitis (SCORAD (Score for Atopic Dermatitis) ≥ 15).
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ROUVAXMeasles vaccine (ROUVAX ®), Schwarz strain (>1000 DICC 50) in 0.5 ml of water for injection. One single subcutaneous injection. | Biological | Rouvax |
| placeboVehicle (water for injection), 0.5 ml, once | Biological | Placebo |
Primary outcome
Effect of anti-measles vaccination on the T cell responses in patients
Time frame: 7 / 10 days after vaccine / placebo injection
4 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2026.
- Results publication: PubMed 28233587Gourru-Lesimple G, Mathieu C, Thevenet T, Guillaume-Vasselin V, Jegou JF, Boer CG, Tomczak K, Bloyet LM, Giraud C, Grande S, Goujon C, Cornu C, Horvat B. Measles virus infection of human keratinocytes: Possible link between measles and atopic dermatitis. J Dermatol Sci. 2017 May;86(2):97-105. doi: 10.1016/j.jdermsci.2017.01.015. Epub 2017 Feb 10.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Branka Horvat, MD, PhD study director
Institut National de la Santé Et de la Recherche Médicale, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ROUVAX in people with Atopic Dermatitis, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of anti-measles vaccination on the T cell responses in patients (time frame: 7 / 10 days after vaccine / placebo injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00820820, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2026.