Atopic Dermatitis
Conditions
Keywords
Atopic Dermatitis, immunosuppression, Measles vaccine, T lymphocytes, Atopic Dermatitis in adults
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.
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.
Interventions
BIOLOGICALROUVAX
Measles vaccine (ROUVAX ®), Schwarz strain (\>1000 DICC 50) in 0.5 ml of water for injection. One single subcutaneous injection.
BIOLOGICALplacebo
Vehicle (water for injection), 0.5 ml, once
Sponsors
Institut National de la Santé Et de la Recherche Médicale, France
Ministry of Health, France
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effect of anti-measles vaccination on the T cell responses in patients | 7 / 10 days after vaccine / placebo injection |
Secondary
| Measure | Time frame |
|---|---|
| Clinical evolution of AD, as measured by the SCORAD | 3 weeks after injection |
| blood level of measles specific IgE and antibodies | 3 weeks after injection |
| Biomarkers - E selectin, CD25, soluble CD30, CCL 17 and CCL 18 | 7 days, 14 days, 3 weeks after injection |
| phenotypic characteristics of T lymphocytes | 7 days, 14 days, 3 weeks, and 6 weeks after injection |
Countries
France
Contacts
STUDY_DIRECTORBranka Horvat, MD, PhD
Institut National de la Santé Et de la Recherche Médicale, France
Outcome results
None listed