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Role of Tyrosine Kinase Lyn and Cleaved Form by Caspases in Psoriasis
This study is currently recruiting participants.
Verified April 2016 by Centre Hospitalier Universitaire de Nice
Sponsor:
Centre Hospitalier Universitaire de Nice
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier:
NCT01538342
First received: January 13, 2012
Last updated: April 22, 2016
Last verified: April 2016
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Purpose
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.
| Condition | Intervention |
|---|---|
| Psoriasis Atopic Dermatitis | Other: 3 Biopsies Other: 2 biopsies Other: biopsy |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Basic Science |
| Official Title: | Role of Tyrosine Kinase Lyn and Cleaved Form by Caspases in Psoriasis |
Resource links provided by NLM:
Further study details as provided by Centre Hospitalier Universitaire de Nice:
Primary Outcome Measures:
- 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.
- 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).
- 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.
Secondary Outcome Measures:
- 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.
| Estimated Enrollment: | 170 |
| Study Start Date: | July 2012 |
| Estimated Study Completion Date: | July 2016 |
| Estimated Primary Completion Date: | July 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
chronic plaque psoriasis
3 biopsies: 2 lesional and 1 non-lesional
|
Other: 3 Biopsies
3 biopsies: 2 lesional and 1 non-lesional
|
|
pustular psoriasis
3 biopsies: 2 lesional and 1 non-lesional
|
Other: 3 Biopsies
3 biopsies: 2 lesional and 1 non-lesional
|
|
erythrodermic psoriasis
3 biopsies: 2 lesional and 1 non-lesional
|
Other: 3 Biopsies
3 biopsies: 2 lesional and 1 non-lesional
|
|
atopic dermatitis
2 biopsies: 1 lesional and 1 non-lesional
|
Other: 2 biopsies
Other Name: 1 lesional and 1 non-lesional
|
|
healthy patients
1 biopsy of healthy skin.
|
Other: biopsy
1 biopsy ok healthy skin
|
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Criteria
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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01538342
Please refer to this study by its ClinicalTrials.gov identifier: NCT01538342
Contacts
| Contact: Jean-Paul ORTONNE, PU-PH | 04 92 03 64 88 ext +33 | ortonne@unice.fr | |
| Contact: Sandrine MARCHETTI, PhD | 04 93 37 70 16 ext +33 | Sandrine.Marchetti@unice.fr |
Locations
| France | |
| Assistance Publique - Hôpitaux de Marseille | Recruiting |
| Marseille, France, 13 005 | |
| Contact: Marie-Aleth RICHARD, PU-PH 04 91 38 79 91 ext +33 mrichard@ap-hm.fr | |
| Principal Investigator: Marie-Aleth RICHARD, PU-PH | |
| University Hospital of Nice | Active, not recruiting |
| Nice, France, 06000 | |
| University Hospital of Toulouse | Not yet recruiting |
| Toulouse, France, 31059 | |
| Contact: Carle PAUL, PU-PH 05 61 77 76 75 ext +33 paul.c@chu-toulouse.fr | |
| Principal Investigator: Carle PAUL, PU-PH | |
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice
Investigators
| Study Director: | Jean-Paul ORTONNE, PU-PH | CHU 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 |
More Information
Additional Information:
| Responsible Party: | Centre Hospitalier Universitaire de Nice |
| ClinicalTrials.gov Identifier: | NCT01538342 History of Changes |
| Other Study ID Numbers: |
11-API-03 |
| Study First Received: | January 13, 2012 |
| Last Updated: | April 22, 2016 |
Additional relevant MeSH terms:
|
Psoriasis Dermatitis Dermatitis, Atopic Eczema Skin Diseases, Papulosquamous Skin Diseases |
Skin Diseases, Genetic Genetic Diseases, Inborn Skin Diseases, Eczematous Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |
ClinicalTrials.gov processed this record on September 21, 2017