Pathophysiological Study of Allergic Contact Dermatitis to Para-Phenylenediamine (PPD). Analysis of Cellular and Molecular Targets in Skin Inflammation

October 3, 2007 updated by: Hospices Civils de Lyon

The current knowledge of the pathophysiology of allergic contact dermatitis is based on the murine model. In this model, CD8+ T cells are effector cells, and CD4+ T cells regulate the response by limiting the expansion of CD8+ T cells. The goal of this study is to characterize the pathophysiology of contact dermatitis, with patients allergic to para-phenylenediamine (PPD).

We suppose that the CD8+ T cells are the effectors of the allergic contact dermatitis, although the regulator cells belong to the LT CD4+ population. We will test our hypothesis on blood samples, and cutaneous biopsies of patients allergic to PPD.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

36

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Lyon, France, 69495
        • Recruiting
        • Jean-François Nicolas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

For both groups:

  • Patients aged from 18 to 65 years old.
  • Both genders eligible for study.
  • Female participants must use a contraceptive method.
  • Feasibility of patch testing.
  • Participants must be able to understand and sign the Informed Consent, and comply with all aspects of the protocol.

  • Patients must be registered in a social security system or with a health insurance coverage

     First group: allergic patients

  • Patients with allergic contact dermatitis to para-phenylenediamine (PPD) based on a history of PPD contact dermatitis and positive PPD patch tests.

     Second group : healthy volunteers

  • No history of PPD allergic contact dermatitis, with a negative PPD patch test.

Exclusion Criteria:

  • Pregnant or lactating women.
  • Evolutive skin disease on the testing zone (lower back).
  • Patients with a clinically significant disease (chronic, recurrent or active).
  • Systemic corticotherapy or immunosuppressive treatment during the previous month, or local corticoid treatment the week before the patch testing.
  • Local or systemic drug use which interacts with the outcome measures.
  • Exposure to sun or UV radiations, 15 days before the patch testing.
  • Patients deprived of their civic rights, in custody, or subject to a tutorial, judiciary or administrative decision.
  • Patients subject to a protection measure.
  • Patients in a critical medical situation.
  • Patients with a personal situation judged by the investigator as unlikely to be compatible with optimal participation in the study, or which could constitute a risk for the patient.
  • Linguistic barrier or psychological profile preventing the patient from signing the consent form.
  • Patient still in an exclusion period following the participation in another clinical trial.
  • Patients having earned more than 4500€ in indemnities for participation in clinical trials during the previous 12 months, including this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Investigators

  • Principal Investigator: Jean-François NICOLAS, MD, Hospices Civils de Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2007

Study Registration Dates

First Submitted

March 7, 2007

First Submitted That Met QC Criteria

March 7, 2007

First Posted (Estimate)

March 8, 2007

Study Record Updates

Last Update Posted (Estimate)

October 4, 2007

Last Update Submitted That Met QC Criteria

October 3, 2007

Last Verified

October 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2006.435

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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