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

Psoriasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04459780
• Other study ID #: CaPSO17
• Status: Completed
• Phase: N/A
• Start date: October 25, 2016
• Est. completion date: November 13, 2017

Study information

• Verified date: July 2020
• Source: Pierre Fabre Dermo Cosmetique
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 13, 2017
• Est. primary completion date: November 13, 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Psoriasis

Intervention

Biological:
• Skin biopsies
3 biopsies on lesion skin (and one more for the first fifteen subjects in group 1)
• Blood sample
One blood sample for the group 1 only.

Locations

Country	Name	City	State
France	Service de Dermatologie - Hôpital Larrey	Toulouse

Sponsors (3)

Lead Sponsor	Collaborator
Pierre Fabre Dermo Cosmetique	Centre National de la Recherche Scientifique, France, Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Expression of Cav1.4 calcium channels in Th17 lymphocytes	Immunohistochemistry (IHC) and in situ hybridation (HIS)	Baseline
Secondary	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	Baseline
Secondary	Transcriptomic signature relating to the signaling channel Cav1.4	qPCR with TLDA technology (TaqMan Low Density Arrrays)	Baseline
Secondary	Epigenetic signature, in particular changes in overall methylation and specific promoter methylation	Pyrosequencing	Baseline