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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00445029
Recruitment Status : Unknown
Verified October 2007 by Hospices Civils de Lyon.
Recruitment status was:  Recruiting
First Posted : March 8, 2007
Last Update Posted : October 4, 2007
Information provided by:
Hospices Civils de Lyon

Brief Summary:

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 or disease
Allergic Contact Dermatitis

Study Type : Observational
Estimated Enrollment : 36 participants
Observational Model: Defined Population
Time Perspective: Longitudinal
Time Perspective: Prospective
Official Title: Pathophysiological Study of Allergic Contact Dermatitis to Para-Phenylenediamine (PPD). Analysis of Cellular and Molecular Targets in Skin Inflammation
Study Start Date : March 2007

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00445029

Contact: Marc Vocanson, PhD 33 4 78 86 72

Jean-François Nicolas Recruiting
Lyon, France, 69495
Sponsors and Collaborators
Hospices Civils de Lyon
Principal Investigator: Jean-François Nicolas, MD Hospices Civils de Lyon Identifier: NCT00445029     History of Changes
Other Study ID Numbers: 2006.435
First Posted: March 8, 2007    Key Record Dates
Last Update Posted: October 4, 2007
Last Verified: October 2007

Keywords provided by Hospices Civils de Lyon:
Allergic contact dermatitis
effector cells
regulatory cells

Additional relevant MeSH terms:
Dermatitis, Contact
Dermatitis, Allergic Contact
Pathologic Processes
Skin Diseases
Skin Diseases, Eczematous
Hypersensitivity, Delayed
Immune System Diseases