Status:
UNKNOWN
Pathophysiological Study of Allergic Contact Dermatitis to Para-Phenylenediamine (PPD). Analysis of Cellular and Molecular Targets in Skin Inflammation
Lead Sponsor:
Hospices Civils de Lyon
Conditions:
Allergic Contact Dermatitis
Eligibility:
All Genders
18-65 years
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 limi...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2007
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00445029
Start Date
March 1 2007
Last Update
October 4 2007
Active Locations (1)
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1
Jean-François Nicolas
Lyon, France, 69495