NCT01538342

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
170

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 13, 2012

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 24, 2012

Completed
4 months until next milestone

Study Start

First participant enrolled

July 1, 2012

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

March 31, 2026

Status Verified

March 1, 2026

Enrollment Period

4 years

First QC Date

January 13, 2012

Last Update Submit

March 26, 2026

Conditions

PsoriasisAtopic Dermatitis

Outcome Measures

Primary Outcomes (3)

  • Cleavage of Lyn

    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

    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

    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 Outcomes (1)

  • Development of a monoclonal antibodyspecific for the cleaved form of caspases by Lyn

    1 day

Study Arms (5)

chronic plaque psoriasis

OTHER

3 biopsies: 2 lesional and 1 non-lesional

Other: 3 Biopsies

pustular psoriasis

OTHER

3 biopsies: 2 lesional and 1 non-lesional

Other: 3 Biopsies

erythrodermic psoriasis

OTHER

3 biopsies: 2 lesional and 1 non-lesional

Other: 3 Biopsies

atopic dermatitis

OTHER

2 biopsies: 1 lesional and 1 non-lesional

Other: 2 biopsies

healthy patients

OTHER

1 biopsy of healthy skin.

Other: biopsy

Interventions

3 BiopsiesOTHER

3 biopsies: 2 lesional and 1 non-lesional

chronic plaque psoriasiserythrodermic psoriasispustular psoriasis
2 biopsiesOTHER
Also known as: 1 lesional and 1 non-lesional
atopic dermatitis
biopsyOTHER

1 biopsy ok healthy skin

healthy patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Assistance Publique - Hôpitaux de Marseille

Marseille, 13 005, France

Location

University Hospital of Nice

Nice, 06000, France

Location

University Hospital of Toulouse

Toulouse, 31059, France

Location

Related Publications (1)

  • Aira LE, Goncalves D, Bossowski JP, Rubio-Patino C, Chiche J, Paul-Bellon R, Mondragon L, Gesson M, Lecucq-Ottavi P, Obba S, Colosetti P, Luciano F, Bailly-Maitre B, Boyer L, Jacquel A, Robert G, Ricci JE, Ortonne JP, Passeron T, Lacour JP, Auberger P, Marchetti S. Caspase 1/11 Deficiency or Pharmacological Inhibition Mitigates Psoriasis-Like Phenotype in Mice. J Invest Dermatol. 2019 Jun;139(6):1306-1317. doi: 10.1016/j.jid.2018.11.031. Epub 2018 Dec 17.

    PMID: 30571969RESULT

Related Links

MeSH Terms

Conditions

PsoriasisDermatitis, Atopic

Interventions

Biopsy

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

CytodiagnosisCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisSpecimen HandlingDiagnostic Techniques, SurgicalSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Jean-Paul ORTONNE, PU-PH

    Centre Hospitalier Universitaire de Nice

    STUDY DIRECTOR

  • Sandrine MARCHETTI, PhD

    Institut National de la Santé Et de la Recherche Médicale, France

    STUDY CHAIR

  • Marie-Aleth RICHARD, PU-PH

    AP-HM

    PRINCIPAL INVESTIGATOR

  • Carle PAUL, PU-PH

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2012

First Posted

February 24, 2012

Study Start

July 1, 2012

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

March 31, 2026

Record last verified: 2026-03

Locations

FR(3)