Role of Reverse Transcriptase Inhibitors in the Treatment of Psoriasis (PSORTI-BIO)

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

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

Study Overview

• Status: Completed
• Conditions: Psoriasis
• Intervention / Treatment: Drug: Generic antiretroviral

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34295
    • CHU de Montpellier
  • Nîmes, France, 30029
    • CHU de Nimes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Psoriasis patients	Drug: Generic antiretroviral; 200mg emtricitabine plus 245mg tenofovir diisopropyl fumarate for 7 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage change in endogenous reverse transcriptase	µUI/mL reverse transcriptase activity tested in serum assayed using CAVIDI HS Mg-RT kit	Day 0
Percentage change in endogenous reverse transcriptase	µUI/mL reverse transcriptase activity tested in serum assayed using CAVIDI HS Mg-RT kit	Day 7
Percentage change in Ki67 proliferation marker expression	Percentage of cells positive for Ki67 marker on cutaneous immunohistochemistry	Day 0
Percentage change in Ki67 proliferation marker expression	Percentage of cells positive for Ki67 marker on cutaneous immunohistochemistry	Day 7
Percentage change in CK10 differentiation marker expression	Percentage of cells positive for CK10 marker on cutaneous immunohistochemistry	Day 0
Percentage change in CK10 differentiation marker expression	Percentage of cells positive for CK10 marker on cutaneous immunohistochemistry	Day 7
Percentage change in filaggrin differentiation marker expression	Percentage of cells positive for filaggrin marker on cutaneous immunohistochemistry	Day 0
Percentage change in filaggrin differentiation marker expression	Percentage of cells positive for filaggrin marker on cutaneous immunohistochemistry	Day 7
Percentage change in CD4 inflammation marker expression	Percentage of cells positive for CD4 marker on cutaneous immunohistochemistry	Day 0
Percentage change in CD4 inflammation marker expression	Percentage of cells positive for CD4 marker on cutaneous immunohistochemistry	Day 7
Percentage change in CD8 inflammation marker expression	Percentage of cells positive for CD8 marker on cutaneous immunohistochemistry	Day 0
Percentage change in CD8 inflammation marker expression	Percentage of cells positive for CD8 marker on cutaneous immunohistochemistry	Day 7
Percentage change in CD11c inflammation marker expression	Percentage of cells positive for CD11c marker on cutaneous immunohistochemistry	Day 0
Percentage change in CD11c inflammation marker expression	Percentage of cells positive for CD11c marker on cutaneous immunohistochemistry	Day 7
Average percentage change of Psoriasis Area Severity Index	Scale of four variables of psoriasis severity (minimum score 0 maximum score 72)	Day 7
Number of side effects	Anticipated side effects = diarrhea, vomiting, nausea, dizziness or headache, feeling weak or rash	Day 7
Number of side effects	Anticipated side effects = diarrhea, vomiting, nausea, dizziness or headache, feeling weak or rash	Day 14

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes
• Investigators: Principal Investigator: Pierre Stoebner, Chu Nimes

Study record dates

Study Major Dates

• Study Start (Actual): February 13, 2020
• Primary Completion (Actual): November 29, 2021
• Study Completion (Actual): June 20, 2022

Study Registration Dates

• First Submitted: January 16, 2020
• First Submitted That Met QC Criteria: February 17, 2020
• First Posted (Actual): February 18, 2020

Study Record Updates

• Last Update Posted (Actual): September 28, 2022
• Last Update Submitted That Met QC Criteria: September 27, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Anti-Infective Agents; Antiviral Agents; Anti-Retroviral Agents
• Other Study ID Numbers: AOIGCSMerri/2018/PS-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No