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

NCT00445029 | Unknown

• 1 other identifier: 2006.435
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 1

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Patients having earned more than 4500€ in indemnities for participation in clinical trials during the previous 12 months, including this study.

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Jean-François Nicolas

Lyon, 69495, France

RECRUITING

MeSH Terms

Conditions

Dermatitis, Allergic Contact

Condition Hierarchy (Ancestors)

Dermatitis, Contact; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Delayed; Hypersensitivity; Immune System Diseases

Study Officials

• Jean-François Nicolas, MD

  Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marc Vocanson, PhD

CONTACT

33 4 78 86 72; vocanson@cervi-lyon.inserm.fr

Study Design

• Study Type: observational
• Observational Model: DEFINED POPULATION
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 7, 2007
• First Posted: March 8, 2007
• Study Start: March 1, 2007
• Last Updated: October 4, 2007

Record last verified: 2007-10

Locations

FR (1)