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Characterization and Functionality of Calcium Channels Cav1.4 of Th17 Lymphocytes in Human With Psoriasis

Primary Purpose

Psoriasis

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Skin biopsies
Blood sample
Sponsored by
Pierre Fabre Dermo Cosmetique
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Psoriasis focused on measuring Th17, Cav1.4, Lymphocyte, Channel

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Group 1 : Subject with plaque psoriasis (diagnosis confirmed by dermatologist) with a plaque IGA score ≥ 3
  • Group 2 : Subject with atopic dermatitis according to the UK Working party criteria with an IGA plaque score ≥3

Exlusion Criteria:

  • Group 1 : Other chronic inflammatory dermatosis than plaque psoriasis at the sites to be sampled
  • Group 2 : Other chronic inflammatory dermatosis than Atopic Dermatitis at the sites to be sampled
  • For both groups: Ongoing treatment with calcium channel blockers
  • For both groups: Any current topical treatment on the biopsied or systemic plaque for psoriasis or AD (including phototherapy)

Sites / Locations

  • Service de Dermatologie - Hôpital Larrey

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group 1 : 20 subjects with plaque psoriasis

Group 2 : 10 subjects with atopic dermatitis

Arm Description

Intervention: skin biopsies and blood sample

Intervention: skin biopsies

Outcomes

Primary Outcome Measures

Expression of Cav1.4 calcium channels in Th17 lymphocytes
Immunohistochemistry (IHC) and in situ hybridation (HIS)

Secondary Outcome Measures

Role of Cav1.4 channels on the activation of Th17 lymphocytes
Fonctional study : intracellular marquing and qPCR (with TLDA technology (TaqMan Low Density Arrrays)) and ELISA method
Transcriptomic signature relating to the signaling channel Cav1.4
qPCR with TLDA technology (TaqMan Low Density Arrrays)
Epigenetic signature, in particular changes in overall methylation and specific promoter methylation
Pyrosequencing

Full Information

First Posted
July 1, 2020
Last Updated
July 10, 2020
Sponsor
Pierre Fabre Dermo Cosmetique
Collaborators
Centre National de la Recherche Scientifique, France, Institut National de la Santé Et de la Recherche Médicale, France
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1. Study Identification

Unique Protocol Identification Number
NCT04459780
Brief Title
Characterization and Functionality of Calcium Channels Cav1.4 of Th17 Lymphocytes in Human With Psoriasis
Official Title
Characterization and Functionality of Calcium Channels Cav1.4 of Th17 Lymphocytes in Human With Psoriasis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
October 25, 2016 (Actual)
Primary Completion Date
November 13, 2017 (Actual)
Study Completion Date
November 13, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pierre Fabre Dermo Cosmetique
Collaborators
Centre National de la Recherche Scientifique, France, Institut National de la Santé Et de la Recherche Médicale, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
It's clearly known that lymphocyte activation in particular Th17 response, plays a major role in the development of plaque psoriasis. New therapies targeting this pathway are showing great clinical efficacy in patients with moderate to severe plaque psoriasis. Pioneering observations have shown that the expression of Cav1.4 channels in Th17 lymphocytes and they're functional role is supported by the inhibition of IL-17 production by a pharmacological inhibitor of Cav1 channels that is effective in a mouse model of Psoriasis. This data strongly suggest that the Cav1.4 channel, via its involvement in the signalling responsible for the production of Th17 cytokines represents an interesting therapeutic target in Psoriasis. The aim of the study is to explore biological functions related to the activation of the Cav1.4 pathway in Psoriasis.
Detailed Description
Evaluate the expression of Cav1.4 calcium channels by Th17 lymphocytes from plaque psoriasis. To assess: The role of Cav1.4 channels on the activation of Th17 lymphocytes The transcriptomic signature relating to the signalling channel Cav1.4 The epigenetic signature, in particular changes in overall methylation and specific promoter methylation

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis
Keywords
Th17, Cav1.4, Lymphocyte, Channel

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Monocentric, open-label, comparative, parallel group and intra-individual patho-physiological study : Group 1 : 20 subjects with plaque psoriasis Group 2 : 10 subject with atopic dermatitis
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1 : 20 subjects with plaque psoriasis
Arm Type
Experimental
Arm Description
Intervention: skin biopsies and blood sample
Arm Title
Group 2 : 10 subjects with atopic dermatitis
Arm Type
Experimental
Arm Description
Intervention: skin biopsies
Intervention Type
Biological
Intervention Name(s)
Skin biopsies
Intervention Description
3 biopsies on lesion skin (and one more for the first fifteen subjects in group 1)
Intervention Type
Biological
Intervention Name(s)
Blood sample
Intervention Description
One blood sample for the group 1 only.
Primary Outcome Measure Information:
Title
Expression of Cav1.4 calcium channels in Th17 lymphocytes
Description
Immunohistochemistry (IHC) and in situ hybridation (HIS)
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
Role of Cav1.4 channels on the activation of Th17 lymphocytes
Description
Fonctional study : intracellular marquing and qPCR (with TLDA technology (TaqMan Low Density Arrrays)) and ELISA method
Time Frame
Baseline
Title
Transcriptomic signature relating to the signaling channel Cav1.4
Description
qPCR with TLDA technology (TaqMan Low Density Arrrays)
Time Frame
Baseline
Title
Epigenetic signature, in particular changes in overall methylation and specific promoter methylation
Description
Pyrosequencing
Time Frame
Baseline

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Group 1 : Subject with plaque psoriasis (diagnosis confirmed by dermatologist) with a plaque IGA score ≥ 3 Group 2 : Subject with atopic dermatitis according to the UK Working party criteria with an IGA plaque score ≥3 Exlusion Criteria: Group 1 : Other chronic inflammatory dermatosis than plaque psoriasis at the sites to be sampled Group 2 : Other chronic inflammatory dermatosis than Atopic Dermatitis at the sites to be sampled For both groups: Ongoing treatment with calcium channel blockers For both groups: Any current topical treatment on the biopsied or systemic plaque for psoriasis or AD (including phototherapy)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul CARL, Pr.
Organizational Affiliation
Service de Dermatologie - Hôpital Larrey
Official's Role
Principal Investigator
Facility Information:
Facility Name
Service de Dermatologie - Hôpital Larrey
City
Toulouse
ZIP/Postal Code
31400
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Characterization and Functionality of Calcium Channels Cav1.4 of Th17 Lymphocytes in Human With Psoriasis

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