Clinical trial NCT04274595: Role of Reverse Transcriptase Inhibitors in the Treatment of Psoriasis
Official title: Role of Reverse Transcriptase Inhibitors in the Treatment of Psoriasis: A Proof of Biological Concept Test
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psoriasis
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2020-02-18
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of patients no longer presenting S9.6:D5H6 RNA:DNA duplex
timeFrame: Day 0
measure: Percentage of patients no longer presenting S9.6:D5H6 RNA:DNA duplex
timeFrame: Day 7
Secondary outcomes:
measure: Percentage change in endogenous reverse transcriptase
timeFrame: Day 0
measure: Percentage change in endogenous reverse transcriptase
timeFrame: Day 7
measure: Percentage change in Ki67 proliferation marker expression
timeFrame: Day 0
measure: Percentage change in Ki67 proliferation marker expression
timeFrame: Day 7
measure: Percentage change in CK10 differentiation marker expression
timeFrame: Day 0
measure: Percentage change in CK10 differentiation marker expression
timeFrame: Day 7
measure: Percentage change in filaggrin differentiation marker expression
timeFrame: Day 0
measure: Percentage change in filaggrin differentiation marker expression
timeFrame: Day 7
measure: Percentage change in CD4 inflammation marker expression
timeFrame: Day 0
measure: Percentage change in CD4 inflammation marker expression
timeFrame: Day 7
measure: Percentage change in CD8 inflammation marker expression
timeFrame: Day 0
measure: Percentage change in CD8 inflammation marker expression
timeFrame: Day 7
measure: Percentage change in CD11c inflammation marker expression
timeFrame: Day 0
measure: Percentage change in CD11c inflammation marker expression
timeFrame: Day 7
measure: Average percentage change of Psoriasis Area Severity Index
timeFrame: Day 7
measure: Number of side effects
timeFrame: Day 7
measure: Number of side effects
timeFrame: Day 14
Other outcomes:
Locations:
city: Montpellier
country: France
facility: CHU de Montpellier
city: Nîmes
country: France
facility: CHU de Nimes
Study officials:
affiliation: CHU Nimes
name: Pierre Stoebner
role: PRINCIPAL_INVESTIGATOR
References: