Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2007-007267-25 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Ministry of Health, France | OTHER_GOV |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rouvax | Active Comparator |
| |
| Placebo | Placebo Comparator | Sub cutaneous injection of vehicle |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ROUVAX | Biological | Measles vaccine (ROUVAX ®), Schwarz strain (>1000 DICC 50) in 0.5 ml of water for injection. One single subcutaneous injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Effect of anti-measles vaccination on the T cell responses in patients | 7 / 10 days after vaccine / placebo injection |
| Measure | Description | 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Branka Horvat, MD, PhD | Institut National de la Santé Et de la Recherche Médicale, France | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Unité de Recherche Clinique et Immunologique | Pierre-Bénite | Lyon | 69495 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28233587 | Result | 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. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| placebo | Biological | Vehicle (water for injection), 0.5 ml, once |
|
| 7 days, 14 days, 3 weeks after injection |
| phenotypic characteristics of T lymphocytes | 7 days, 14 days, 3 weeks, and 6 weeks after injection |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |