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

Allergic Contact Dermatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00445029
• Other study ID #: 2006.435
• Status: Recruiting
• Phase: N/A
• First received: March 7, 2007
• Last updated: October 3, 2007
• Start date: March 2007

Study information

• Verified date: October 2007
• Source: Hospices Civils de Lyon
• Contact: Marc Vocanson, PhD
• Phone: 33 4 78 86 72
• Email: vocanson[@]cervi-lyon.inserm.fr
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Observational Model: Defined Population, Time Perspective: Longitudinal

Related Conditions & MeSH terms

• Allergic Contact Dermatitis
• Dermatitis
• Dermatitis, Allergic Contact
• Dermatitis, Contact
• Eczema

Locations

Country	Name	City	State
France	Jean-François Nicolas	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France,