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

Primary Purpose

Atopic Dermatitis

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
ROUVAX
placebo
Sponsored by
Institut National de la Santé Et de la Recherche Médicale, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Atopic Dermatitis focused on measuring Atopic Dermatitis, immunosuppression, Measles vaccine, T lymphocytes, Atopic Dermatitis in adults

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Unité de Recherche Clinique et Immunologique

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Rouvax

Placebo

Arm Description

Sub cutaneous injection of vehicle

Outcomes

Primary Outcome Measures

Effect of anti-measles vaccination on the T cell responses in patients

Secondary Outcome Measures

Clinical evolution of AD, as measured by the SCORAD
blood level of measles specific IgE and antibodies
Biomarkers - E selectin, CD25, soluble CD30, CCL 17 and CCL 18
phenotypic characteristics of T lymphocytes

Full Information

First Posted
January 9, 2009
Last Updated
February 11, 2020
Sponsor
Institut National de la Santé Et de la Recherche Médicale, France
Collaborators
Ministry of Health, France
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1. Study Identification

Unique Protocol Identification Number
NCT00820820
Brief Title
IDA (Immunothérapie de la Dermatite Atopique) Adult - Immunotherapy in Atopic Dermatitis
Acronym
IDA-Adult
Official Title
Immunotherapy of Atopic Dermatitis in Adult Patients by Anti-measles Vaccination IDA (Immunothérapie de la Dermatite Atopique)Protocol
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
January 9, 2009 (Actual)
Primary Completion Date
March 26, 2012 (Actual)
Study Completion Date
March 26, 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut National de la Santé Et de la Recherche Médicale, France
Collaborators
Ministry of Health, France

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis
Keywords
Atopic Dermatitis, immunosuppression, Measles vaccine, T lymphocytes, Atopic Dermatitis in adults

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rouvax
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Sub cutaneous injection of vehicle
Intervention Type
Biological
Intervention Name(s)
ROUVAX
Intervention Description
Measles vaccine (ROUVAX ®), Schwarz strain (>1000 DICC 50) in 0.5 ml of water for injection. One single subcutaneous injection.
Intervention Type
Biological
Intervention Name(s)
placebo
Intervention Description
Vehicle (water for injection), 0.5 ml, once
Primary Outcome Measure Information:
Title
Effect of anti-measles vaccination on the T cell responses in patients
Time Frame
7 / 10 days after vaccine / placebo injection
Secondary Outcome Measure Information:
Title
Clinical evolution of AD, as measured by the SCORAD
Time Frame
3 weeks after injection
Title
blood level of measles specific IgE and antibodies
Time Frame
3 weeks after injection
Title
Biomarkers - E selectin, CD25, soluble CD30, CCL 17 and CCL 18
Time Frame
7 days, 14 days, 3 weeks after injection
Title
phenotypic characteristics of T lymphocytes
Time Frame
7 days, 14 days, 3 weeks, and 6 weeks after injection

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Branka Horvat, MD, PhD
Organizational Affiliation
Institut National de la Santé Et de la Recherche Médicale, France
Official's Role
Study Director
Facility Information:
Facility Name
Unité de Recherche Clinique et Immunologique
City
Pierre-Bénite
State/Province
Lyon
ZIP/Postal Code
69495
Country
France

12. IPD Sharing Statement

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

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