Role of Reverse Transcriptase Inhibitors in the Treatment of Psoriasis

Not Applicable

Completed

• Conditions: Psoriasis
• Interventions: Drug: Generic antiretroviral

• Registration Number: NCT04274595
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-01-16
• Study Start: 2020-02-13
• Study First Submitted QC: 2020-02-17
• Study First Posted: 2020-02-18
• Primary Completion: 2021-11-29
• Study Completion: 2022-06-20
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-27
• Last Update Posted: 2022-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Psoriasis patients	Generic antiretroviral	-

Primary Outcome Measures

Name	Time	Method
Percentage of patients no longer presenting S9.6:D5H6 RNA:DNA duplex	Day 7	Biopsy screening for S9.6:D5H6 RNA:DNA duplex by immunofluorescence

Secondary Outcome Measures

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

Trial Locations

Locations (2)

CHU de Nimes; 🇫🇷 Nîmes, France

CHU de Montpellier; 🇫🇷 Montpellier, France