Allergic Contact DermatitisNCT00445029
Pathophysiological Study of Allergic Contact Dermatitis to Para-Phenylenediamine (PPD). Analysis of Cellular and Molecular Targets in Skin Inflammation
An observational study of Allergic Contact Dermatitis, run by Hospices Civils de Lyon at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Allergic Contact Dermatitis
- How many people
- 36 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2007to not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Medical subject headings
- Dermatitis, Allergic Contact
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2007 (estimated)
- Study startMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic Contact DermatitisStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Defined population
- Time perspective
- Prospective
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Investigators
- Jean-François Nicolas, MD, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00445029
- Sponsor's protocol ID
- 2006.435
- Status last verified
- Oct 2007
- First submitted
- 7 Mar 2007
- Last updated
- 4 Oct 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pathophysiological Study of Allergic Contact Dermatitis to Para-Phenylenediamine (PPD). Analysis of Cellular and Molecular Targets in Skin Inflammation
- ClinicalTrials.gov ID
- NCT00445029
- Acronym / sponsor ID
- 2006.435
- Conditions
- Allergic Contact Dermatitis
- Keywords
- Allergic contact dermatitis, para-phenylenediamine, effector cells, regulatory cells, pathophysiology
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Mar 2007
- First posted
- 8 Mar 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Defined population
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-François Nicolas, MD principal investigator
Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Allergic Contact Dermatitis, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Oct 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marc Vocanson, PhD (33 4 78 86 72, vocanson@cervi-lyon.inserm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2007.