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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2007 by Hospices Civils de Lyon.
Recruitment status was  Recruiting
Information provided by:
Hospices Civils de Lyon Identifier:
First received: March 7, 2007
Last updated: October 3, 2007
Last verified: October 2007

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.

Allergic Contact Dermatitis

Study Type: Observational
Study Design: Observational Model: Defined Population
Time Perspective: Longitudinal
Official Title: Pathophysiological Study of Allergic Contact Dermatitis to Para-Phenylenediamine (PPD). Analysis of Cellular and Molecular Targets in Skin Inflammation

Resource links provided by NLM:

Further study details as provided by Hospices Civils de Lyon:

Estimated Enrollment: 36
Study Start Date: March 2007

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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
  More Information Identifier: NCT00445029     History of Changes
Other Study ID Numbers: 2006.435 
Study First Received: March 7, 2007
Last Updated: October 3, 2007
Health Authority: France: Ministry of Health

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

Additional relevant MeSH terms:
Dermatitis, Allergic Contact
Dermatitis, Contact
Hypersensitivity, Delayed
Immune System Diseases
Skin Diseases
Skin Diseases, Eczematous processed this record on May 26, 2016