Pathophysiological Study of Allergic Contact Dermatitis to Para-Phenylenediamine (PPD). Analysis of Cellular and Molecular Targets in Skin Inflammation
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.
Conditions
- Allergic Contact Dermatitis
Study Type
Observational
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
36
Contact Details
Please refer to this study by its ClinicalTrials.gov identifier: NCT00445029
Contacts
Marc Vocanson, PhD
33 4 78 86 72
vocanson@cervi-lyon.inserm.fr
Locations
Hospices Civils de Lyon
Lyon
France, 69495
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
Principal Investigator:
Jean-François Nicolas, MD
Hospices Civils de Lyon
Dates
Tags
Created by: