Role of Reverse Transcriptase Inhibitors in the Treatment of Psoriasis

NCT ID: NCT04274595

Last Updated: 2025-12-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-13
• Study Completion Date: 2022-06-20

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

Conditions

Psoriasis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Psoriasis patients

Group Type: EXPERIMENTAL

Generic antiretroviral

Intervention Type: DRUG

200mg emtricitabine plus 245mg tenofovir diisopropyl fumarate for 7 days

Interventions

Generic antiretroviral

200mg emtricitabine plus 245mg tenofovir diisopropyl fumarate for 7 days

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pierre Stoebner

Role: PRINCIPAL_INVESTIGATOR

CHU Nimes

Locations

CHU de Montpellier

Montpellier, , France

CHU de Nimes

Nîmes, , France

Countries

France

Other Identifiers

2019-002236-91

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

AOIGCSMerri/2018/PS-01

Identifier Type: -

Identifier Source: org_study_id