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

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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 characterise 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.

Official Title

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


  • Allergic Contact Dermatitis

Study Type


Study Design

Longitudinal, Defined Population, Prospective Study.

Further Details

Study Start

March 2007

Eligibility & Criteria

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

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.

Total Enrolment


Contact Details

Please refer to this study by its identifier: NCT00445029


Marc Vocanson, PhD
33 4 78 86 72    


Hospices Civils de Lyon 
France, 69495

Sponsors and Collaborators

Hospices Civils de Lyon


Principal Investigator:      

Jean-François Nicolas, MD 
Hospices Civils de Lyon   

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Posted On: 1 January, 2013
Modified On: 16 September, 2014


Created by: myVMC