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

NCT ID: NCT00445029

Last Updated: 2007-10-04

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 36 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-03-31

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.

Conditions

Allergic Contact Dermatitis

Keywords

Allergic contact dermatitis; para-phenylenediamine; effector cells; regulatory cells; pathophysiology

Study Design

• Observational Model Type: DEFINED_POPULATION
• Study Time Perspective: PROSPECTIVE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Principal Investigators

Jean-François Nicolas, MD

Role: PRINCIPAL_INVESTIGATOR

Hospices Civils de Lyon

Locations

Jean-François Nicolas

Lyon, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Marc Vocanson, PhD

Role: CONTACT

Phone: 33 4 78 86 72

Email: vocanson@cervi-lyon.inserm.fr

Other Identifiers

2006.435

Identifier Type: -

Identifier Source: org_study_id