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

Sponsor

Institut National de la Santé Et de la Recherche Médicale, France (Other)

Overall Status

Completed

CT.gov ID

NCT00820820

Collaborator

Ministry of Health, France (Other)

Enrollment

Location

Arms

38.5

Actual Duration (Months)

0.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Atopic Dermatitis	Biological: ROUVAX Biological: placebo	N/A

Detailed Description

This trial is aimed at demonstrating that measles vaccine is able to create an immunomodulation and to improve AD symptoms.

Study Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Basic Science

Official Title:

Immunotherapy of Atopic Dermatitis in Adult Patients by Anti-measles Vaccination IDA (Immunothérapie de la Dermatite Atopique)Protocol

Actual Study Start Date :

Jan 9, 2009

Actual Primary Completion Date :

Mar 26, 2012

Actual Study Completion Date :

Mar 26, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Rouvax	Biological: ROUVAX Measles vaccine (ROUVAX ®), Schwarz strain (>1000 DICC 50) in 0.5 ml of water for injection. One single subcutaneous injection.
Placebo Comparator: Placebo Sub cutaneous injection of vehicle	Biological: placebo Vehicle (water for injection), 0.5 ml, once

Arm

Intervention/Treatment

Active Comparator: Rouvax

Biological: ROUVAX

Measles vaccine (ROUVAX ®), Schwarz strain (>1000 DICC 50) in 0.5 ml of water for injection. One single subcutaneous injection.

Placebo Comparator: Placebo

Sub cutaneous injection of vehicle

Biological: placebo

Vehicle (water for injection), 0.5 ml, once

Outcome Measures

Primary Outcome Measures

Effect of anti-measles vaccination on the T cell responses in patients [7 / 10 days after vaccine / placebo injection]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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).