- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01538342
Role of Tyrosine Kinase Lyn and Cleaved Form by Caspases in Psoriasis
Psoriasis is a chronic autoimmune disorder of the skin. In this disease, the inflammatory caspases, cysteine proteases involved in the processing of many proteins, are activated. Transgenic mice expressing the cleaved form of caspases by Lyn, a tyrosine kinase Src family, develop an inflammatory syndrome with the characteristics of human psoriasis.
To clarify the relationship between the cleaved form of Lyn by caspases and psoriasis, the investigators intend to develop a clinical study to analyze the expression, cleavage and activity of Lyn and the activation of caspases from skin biopsies of patients with this disease.
This study will be conducted on a cohort of patients with different forms of psoriasis (plaque, pustular and erythrodermic) and atopic dermatitis, another skin disorder associated with chronic inflammation. Thus, the investigators will evaluate the expression and activity of Lyn from skin lesion (L) and non-lesional (NL) from the same patient in parallel with the level of caspase activation and apoptotic inflammatory.
Thus, the investigators will verify that the cleavage by caspases of Lyn is associated specifically with psoriasis, as the investigators believe, or more generally to the skin inflammation. The investigators work would then define the cleavage by caspases of Lyn as a new potential marker of human psoriasis.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Marseille, France, 13 005
- Assistance Publique - Hopitaux de Marseille
-
Nice, France, 06000
- University Hospital of Nice
-
Toulouse, France, 31059
- University Hospital of Toulouse
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Psoriasis arms:
- Plaque psoriasis and erythrodermic more than 10% of body surface area.
Pustular psoriasis of at least 1% of body surface.
- Atopic dermatitis arm:Patients with atopic dermatitis has been identified and inflammatory lesions on the skin.
- Healthy arm:People not suffering from any skin disease
Exclusion Criteria:
- Systemic treatment of psoriasis for at least 4 weeks and / or local treatment for at least 2 weeks at the time of study entry.
- Patient with significant infection and / or immunocompromised.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: chronic plaque psoriasis
3 biopsies: 2 lesional and 1 non-lesional
|
3 biopsies: 2 lesional and 1 non-lesional
|
|
Other: pustular psoriasis
3 biopsies: 2 lesional and 1 non-lesional
|
3 biopsies: 2 lesional and 1 non-lesional
|
|
Other: erythrodermic psoriasis
3 biopsies: 2 lesional and 1 non-lesional
|
3 biopsies: 2 lesional and 1 non-lesional
|
|
Other: atopic dermatitis
2 biopsies: 1 lesional and 1 non-lesional
|
Other Names:
|
|
Other: healthy patients
1 biopsy of healthy skin.
|
1 biopsy ok healthy skin
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cleavage of Lyn
Time Frame: 1 day
|
The cleavage of Lyn will be determined in the different extracts of skin of patients with western blotting using an antibody specific for Lyn recognizing the native form but also the form cleaved by caspases.
|
1 day
|
|
Expression levels of Lyn
Time Frame: 1 day
|
The expression levels of Lyn and its cleaved form will be quantified using the software MultiGauge.
The investigators will also determine the level of activity of Lyn using an antibody directed against the active form phosphorylated.
The level of expression of proteins of interest will be reported at the level of protein expression control (ERK2) whose expression does not vary depending on the samples (load control).
|
1 day
|
|
Specific activity of apoptotic caspases 3, 6, 7, 8 and 9, and inflammatory caspases 1, 4, and 5
Time Frame: 1 day
|
The investigators will determine the specific activity of apoptotic caspases 3, 6, 7, 8 and 9, and inflammatory caspases 1, 4, and 5 test microplate.
The principle of this test is based on the use of a specific substrate of caspases coupled to a fluorochrome that fluoresces when it is released after the action of caspase-level target aspartate.
The fluorescence emission, which is proportional to the amount of active caspase in the sample is then measured with a fluorometer.
|
1 day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Development of a monoclonal antibodyspecific for the cleaved form of caspases by Lyn
Time Frame: 1 day
|
Development of a monoclonal antibody specific for the form cleaved by caspases of Lyn.
Once obtained and validated, this tool will be especially useful for immunohistological analysis of Lyn on skin sections from patients with psoriasis.
Then we can also analyze which skin cells express preferentially cleaved form of Lyn.
|
1 day
|
Collaborators and Investigators
Investigators
- Study Director: Jean-Paul ORTONNE, PU-PH, Centre Hospitalier Universitaire de Nice
- Study Chair: Sandrine MARCHETTI, PhD, Institut National de la Santé Et de la Recherche Médicale, France
- Principal Investigator: Marie-Aleth RICHARD, PU-PH, AP-HM
- Principal Investigator: Carle PAUL, PU-PH, University Hospital, Toulouse
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Genetic Diseases, Inborn
- Immune System Diseases
- Hypersensitivity, Immediate
- Hypersensitivity
- Skin Diseases, Papulosquamous
- Skin Diseases
- Skin Diseases, Genetic
- Skin Diseases, Eczematous
- Dermatitis
- Congenital, Hereditary, and Neonatal Diseases and Abnormalities
- Skin and Connective Tissue Diseases
- Psoriasis
- Dermatitis, Atopic
- Investigative Techniques
- Specimen Handling
- Clinical Laboratory Techniques
- Diagnostic Techniques and Procedures
- Diagnosis
- Surgical Procedures, Operative
- Cytological Techniques
- Cytodiagnosis
- Diagnostic Techniques, Surgical
- Biopsy
Other Study ID Numbers
- 11-API-03
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Psoriasis
-
ProgenaBiomeWithdrawnPsoriasis | Psoriasis Vulgaris | Psoriasis of Scalp | Psoriatic Plaque | Psoriasis Universalis | Psoriasis Face | Psoriasis Nail | Psoriasis Diffusa | Psoriasis Punctata | Psoriasis Palmaris | Psoriasis Circinata | Psoriasis Annularis | Psoriasis Genital | Psoriasis GeographicaUnited States
-
Clin4allActive, not recruitingPsoriasis of Scalp | Psoriasis Nail | Psoriasis Palmaris | Psoriasis Genital | Psoriasis PlantarisFrance
-
Alumis IncActive, not recruitingPsoriasis | Plaque Psoriasis | Psoriasis (PsO) | Moderate Psoriasis | Severe PsoriasisUnited States, Canada, Australia, Germany, Spain, Hungary, Japan, Bulgaria, Poland, Czechia, Estonia, Latvia, Puerto Rico, Portugal, South Korea, France
-
Innovaderm Research Inc.CompletedScalp Psoriasis | Pustular Palmo-plantar Psoriasis | Non-pustular Palmo-plantar Psoriasis | Elbow Psoriasis | Lower Leg PsoriasisCanada
-
Caja Costarricense de Seguro SocialNot yet recruitingPsoriasis | Psoriasis (PsO) | Psoriasis Arthritis | Psoriasis PatientsCosta Rica
-
Centre of Evidence of the French Society of DermatologyRecruitingPsoriasis | Psoriasis Vulgaris | Psoriasis of Scalp | Psoriatic Plaque | Psoriasis Universalis | Psoriasis Palmaris | Psoriatic Erythroderma | Psoriatic Nail | Psoriasis Guttate | Psoriasis Inverse | Psoriasis PustularFrance
-
AmgenCompletedPsoriasis-Type Psoriasis | Plaque-Type PsoriasisUnited States
-
UCB Biopharma S.P.R.L.CompletedModerate to Severe Psoriasis | Generalized Pustular Psoriasis and Erythrodermic PsoriasisJapan
-
Janssen Pharmaceutical K.K.Active, not recruitingGeneralized Pustular Psoriasis | Erythrodermic PsoriasisJapan
-
Eli Lilly and CompanyCompletedGeneralized Pustular Psoriasis | Erythrodermic PsoriasisJapan
Clinical Trials on 3 Biopsies
-
National Taiwan University HospitalCompleted
-
Peking University Cancer Hospital & InstituteRecruiting
-
Hospital Universitari Vall d'Hebron Research InstituteUnknownLung Transplant RejectionSpain
-
University Hospital, ToulouseNot yet recruiting
-
University of North Carolina, Chapel HillInterpace Diagnostics CorporationCompletedBarretts Esophagus With Dysplasia | Intramucosal AdenocarcinomaUnited States
-
Assistance Publique - Hôpitaux de ParisCompletedCrohn's DiseaseFrance
-
Karolinska InstitutetActive, not recruitingProstate CancerSweden
-
Academisch Medisch Centrum - Universiteit van Amsterdam...UnknownProstatic Neoplasms | Prostate CancerNetherlands
-
University Hospital, MontpellierInstitut de Recherche en Cancérologie de Montpellier (IRCM)UnknownLung AdenocarcinomaFrance
-
Karolinska InstitutetCompleted