IDA (Immunothérapie de la Dermatite Atopique) Adult - Immunotherapy in Atopic Dermatitis (IDA-Adult)

This study has been completed.
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by (Responsible Party):
Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier:
NCT00820820
First received: January 9, 2009
Last updated: October 8, 2012
Last verified: October 2012

January 9, 2009
October 8, 2012
January 2009
July 2012   (final data collection date for primary outcome measure)
Effect of anti-measles vaccination on the T cell responses in patients [ Time Frame: 7 / 10 days after vaccine / placebo injection ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00820820 on ClinicalTrials.gov Archive Site
  • Clinical evolution of AD, as measured by the SCORAD [ Time Frame: 3 weeks after injection ] [ Designated as safety issue: No ]
  • blood level of measles specific IgE and antibodies [ Time Frame: 3 weeks after injection ] [ Designated as safety issue: No ]
  • Biomarkers - E selectin, CD25, soluble CD30, CCL 17 and CCL 18 [ Time Frame: 7 days, 14 days, 3 weeks after injection ] [ Designated as safety issue: No ]
  • phenotypic characteristics of T lymphocytes [ Time Frame: 7 days, 14 days, 3 weeks, and 6 weeks after injection ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
IDA (Immunothérapie de la Dermatite Atopique) Adult - Immunotherapy in Atopic Dermatitis
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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Atopic Dermatitis
  • Biological: ROUVAX
    Measles vaccine (ROUVAX ®), Schwarz strain (>1000 DICC 50) in 0.5 ml of water for injection. One single subcutaneous injection.
  • Biological: placebo
    Vehicle (water for injection), 0.5 ml, once
  • Active Comparator: Rouvax
    Intervention: Biological: ROUVAX
  • Placebo Comparator: Placebo
    Sub cutaneous injection of vehicle
    Intervention: Biological: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
Not Provided
July 2012   (final data collection date for primary outcome measure)

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).
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00820820
C07-38, 2007-007267-25
No
Institut National de la Santé Et de la Recherche Médicale, France
Institut National de la Santé Et de la Recherche Médicale, France
Ministry of Health, France
Study Director: Branka Horvat, MD, PhD Institut National de la Santé Et de la Recherche Médicale, France
Institut National de la Santé Et de la Recherche Médicale, France
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP