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Pathophysiological Study of Allergic Contact Dermatitis to Para-Phenylenediamine (PPD). Analysis of Cellular and Molecular Targets in Skin Inflammation
This study is currently recruiting participants.
Verified by Hospices Civils de Lyon, October 2007
Sponsored by: Hospices Civils de Lyon
Information provided by: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT00445029
  Purpose

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.


Condition
Allergic Contact Dermatitis

U.S. FDA Resources
Study Type: Observational
Study Design: Longitudinal, Defined Population, Prospective Study
Official Title: Pathophysiological Study of Allergic Contact Dermatitis to Para-Phenylenediamine (PPD). Analysis of Cellular and Molecular Targets in Skin Inflammation

Further study details as provided by Hospices Civils de Lyon:

Estimated Enrollment: 36
Study Start Date: March 2007
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00445029

Contacts
Contact: Marc Vocanson, PhD 33 4 78 86 72 vocanson@cervi-lyon.inserm.fr

Locations
France
Jean-François Nicolas Recruiting
Lyon, France, 69495
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
Principal Investigator: Jean-François Nicolas, MD Hospices Civils de Lyon
  More Information

Study ID Numbers: 2006.435
Study First Received: March 7, 2007
Last Updated: October 3, 2007
ClinicalTrials.gov Identifier: NCT00445029  
Health Authority: France: Ministry of Health

Keywords provided by Hospices Civils de Lyon:
Allergic contact dermatitis
para-phenylenediamine
effector cells
regulatory cells
pathophysiology

Study placed in the following topic categories:
Hypersensitivity
Hypersensitivity, Delayed
Skin Diseases
Dermatitis, Allergic Contact
Skin Diseases, Eczematous
Dermatitis, Contact
Inflammation
Dermatitis

Additional relevant MeSH terms:
Pathologic Processes
Immune System Diseases

ClinicalTrials.gov processed this record on January 16, 2009