Role of Reverse Transcriptase Inhibitors in the Treatment of Psoriasis

Psoriasis Clinical Trial

— PSORTI-BIO  

Official title:

Role of Reverse Transcriptase Inhibitors in the Treatment of Psoriasis: A Proof of Biological Concept Test

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04274595
• Other study ID #: AOIGCSMerri/2018/PS-01
• Status: Completed
• Phase: N/A
• Start date: February 13, 2020
• Est. completion date: June 20, 2022

Study information

• Verified date: September 2022
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The investigators hypothesize that the inhibition of endogenous reverse transcriptase would: (1) reduce excess cytosolic DNA, stress initiating the inflammatory loop at the origin of psoriatic lesions, and (2) interrupt the loop and lighten lesions

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: June 20, 2022
• Est. primary completion date: November 29, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Patient suffering from plaque psoriasis for more than a year with at least one active skin lesion> 4 cm2 in the photo-protected area.

• Patient using effective contraception (IUD, adapted pill, condom, etc.)

• The patient must have given their free and informed consent and signed the consent form

• The patient must be a member or beneficiary of a health insurance plan

Exclusion Criteria:

• Patient with another form or stage of psoriasis

• Patient on anti-cytokine treatment during the 6 months (180 days) before inclusion

• Patient under systemic treatment based on (1) corticosteroids, (2) antibiotics, (3) methotrexate, ciclosporin, soriatane, hydroxyurea, apremilast or (4) PUVA, (5) UVB, (6) vitamin D3 during the 4 weeks (28 days) before inclusion

• Patient on topical corticosteroid or retinoid treatment during the 2 weeks (15 days) before inclusion

• Patient with renal insufficiency; taking nephrotoxic agents (aminoglycosides, multiple or high doses of NSAIDs, etc.); creatinine clearance less than 50 ml / min; serum phosphorus below 1.0 mg / dl (0.32 mmol / l).

• Patient with active viral infection (HBV, HCV and HIV), or uncontrolled acute infection.

• Patient with hypersensitivity to one of the active substances or to any of the excipients (non-medicinal ingredients).

• Patient with uncontrolled coagulation disorder, history of keloid scars

• Patient with an allergy to local anesthetics; any condition likely to interfere at the time of the pre-inclusion visit, with the evaluation of the main objective such as eczema, psychiatric disorders

• Patient with uncontrolled systemic parameters The subject is participating in an interventional study, or is in a period of exclusion determined by a previous study

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• Generic antiretroviral
200mg emtricitabine plus 245mg tenofovir diisopropyl fumarate for 7 days

Locations

Country	Name	City	State
France	CHU de Montpellier	Montpellier
France	CHU de Nimes	Nîmes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients no longer presenting S9.6:D5H6 RNA:DNA duplex	Biopsy screening for S9.6:D5H6 RNA:DNA duplex by immunofluorescence	Day 0
Primary	Percentage of patients no longer presenting S9.6:D5H6 RNA:DNA duplex	Biopsy screening for S9.6:D5H6 RNA:DNA duplex by immunofluorescence	Day 7
Secondary	Percentage change in endogenous reverse transcriptase	µUI/mL reverse transcriptase activity tested in serum assayed using CAVIDI HS Mg-RT kit	Day 0
Secondary	Percentage change in endogenous reverse transcriptase	µUI/mL reverse transcriptase activity tested in serum assayed using CAVIDI HS Mg-RT kit	Day 7
Secondary	Percentage change in Ki67 proliferation marker expression	Percentage of cells positive for Ki67 marker on cutaneous immunohistochemistry	Day 0
Secondary	Percentage change in Ki67 proliferation marker expression	Percentage of cells positive for Ki67 marker on cutaneous immunohistochemistry	Day 7
Secondary	Percentage change in CK10 differentiation marker expression	Percentage of cells positive for CK10 marker on cutaneous immunohistochemistry	Day 0
Secondary	Percentage change in CK10 differentiation marker expression	Percentage of cells positive for CK10 marker on cutaneous immunohistochemistry	Day 7
Secondary	Percentage change in filaggrin differentiation marker expression	Percentage of cells positive for filaggrin marker on cutaneous immunohistochemistry	Day 0
Secondary	Percentage change in filaggrin differentiation marker expression	Percentage of cells positive for filaggrin marker on cutaneous immunohistochemistry	Day 7
Secondary	Percentage change in CD4 inflammation marker expression	Percentage of cells positive for CD4 marker on cutaneous immunohistochemistry	Day 0
Secondary	Percentage change in CD4 inflammation marker expression	Percentage of cells positive for CD4 marker on cutaneous immunohistochemistry	Day 7
Secondary	Percentage change in CD8 inflammation marker expression	Percentage of cells positive for CD8 marker on cutaneous immunohistochemistry	Day 0
Secondary	Percentage change in CD8 inflammation marker expression	Percentage of cells positive for CD8 marker on cutaneous immunohistochemistry	Day 7
Secondary	Percentage change in CD11c inflammation marker expression	Percentage of cells positive for CD11c marker on cutaneous immunohistochemistry	Day 0
Secondary	Percentage change in CD11c inflammation marker expression	Percentage of cells positive for CD11c marker on cutaneous immunohistochemistry	Day 7
Secondary	Average percentage change of Psoriasis Area Severity Index	Scale of four variables of psoriasis severity (minimum score 0 maximum score 72)	Day 7
Secondary	Number of side effects	Anticipated side effects = diarrhea, vomiting, nausea, dizziness or headache, feeling weak or rash	Day 7
Secondary	Number of side effects	Anticipated side effects = diarrhea, vomiting, nausea, dizziness or headache, feeling weak or rash	Day 14