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NCT Number: NCT04459780

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

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.

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Key information

Conditions

Psoriasis Cone-Rod Dystrophy, X-Linked, 3 Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

18 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Service de Dermatologie - Hôpital Larrey

Toulouse, 31400, France

About this study

  • 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Skin biopsies

Biological

3 biopsies on lesion skin (and one more for the first fifteen subjects in group 1)

Blood sample

Biological

One blood sample for the group 1 only.

Primary outcomes

  1. Expression of Cav1.4 calcium channels in Th17 lymphocytes

    Time frame: Baseline

    Immunohistochemistry (IHC) and in situ hybridation (HIS)

Secondary outcomes

  1. Role of Cav1.4 channels on the activation of Th17 lymphocytes

    Time frame: Baseline

    Fonctional study : intracellular marquing and qPCR (with TLDA technology (TaqMan Low Density Arrrays)) and ELISA method

  2. Transcriptomic signature relating to the signaling channel Cav1.4

    Time frame: Baseline

    qPCR with TLDA technology (TaqMan Low Density Arrrays)

  3. Epigenetic signature, in particular changes in overall methylation and specific promoter methylation

    Time frame: Baseline

    Pyrosequencing

Sponsors and collaborators

Lead sponsor

Pierre Fabre Dermo Cosmetique

Industry

Collaborators

  • Centre National de la Recherche Scientifique, France
  • Institut National de la Santé Et de la Recherche Médicale, France

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jul 7, 2020
Registry last updated
Jul 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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