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

History of Changes

Tracking Information

First Received Date ^ICMJE

January 9, 2009

Last Updated Date

October 8, 2012

Start Date ^ICMJE

January 2009

Primary Completion Date

July 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00820820 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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

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

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science

Condition ^ICMJE

Atopic Dermatitis

Intervention ^ICMJE

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

Study Arm (s)

Active Comparator: Rouvax
Intervention: Biological: ROUVAX
Placebo Comparator: Placebo
Sub cutaneous injection of vehicle

Intervention: Biological: placebo

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Not Provided

Primary Completion Date

July 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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).

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

France

Administrative Information

NCT Number ^ICMJE

NCT00820820

Other Study ID Numbers ^ICMJE

C07-38, 2007-007267-25

Has Data Monitoring Committee

Responsible Party

Institut National de la Santé Et de la Recherche Médicale, France

Study Sponsor ^ICMJE

Institut National de la Santé Et de la Recherche Médicale, France

Collaborators ^ICMJE

Ministry of Health, France

Investigators ^ICMJE

Study Director:

Branka Horvat, MD, PhD

Institut National de la Santé Et de la Recherche Médicale, France

Information Provided By

Institut National de la Santé Et de la Recherche Médicale, France

Verification Date

October 2012

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

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