NCT00820820

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 9, 2009

Completed
Same day until next milestone

Study Start

First participant enrolled

January 9, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 12, 2009

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 26, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 26, 2012

Completed
Last Updated

March 13, 2026

Status Verified

February 1, 2020

Enrollment Period

3.2 years

First QC Date

January 9, 2009

Last Update Submit

March 11, 2026

Conditions

Atopic Dermatitis

Keywords

Atopic DermatitisimmunosuppressionMeasles vaccineT lymphocytesAtopic Dermatitis in adults

Outcome Measures

Primary Outcomes (1)

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

    7 / 10 days after vaccine / placebo injection

Secondary Outcomes (4)

  • 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

Study Arms (2)

Rouvax

ACTIVE COMPARATOR
Biological: ROUVAX

Placebo

PLACEBO COMPARATOR

Sub cutaneous injection of vehicle

Biological: placebo

Interventions

ROUVAXBIOLOGICAL

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

Rouvax
placeboBIOLOGICAL

Vehicle (water for injection), 0.5 ml, once

Placebo

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adults patients of both sexes, with moderate to severe Atopic Dermatitis (SCORAD (Score for Atopic Dermatitis) ≥ 15).

You may not qualify if:

  • 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,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unité de Recherche Clinique et Immunologique

Pierre-Bénite, Lyon, 69495, France

Location

Related Publications (1)

  • 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.

    PMID: 28233587RESULT

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Branka Horvat, MD, PhD

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

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 9, 2009

First Posted

January 12, 2009

Study Start

January 9, 2009

Primary Completion

March 26, 2012

Study Completion

March 26, 2012

Last Updated

March 13, 2026

Record last verified: 2020-02

Locations

FR(1)