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

C

Centre Hospitalier Universitaire de Nīmes

Status

Completed

Conditions

Psoriasis

Treatments

Drug: Generic antiretroviral

Study type

Interventional

Funder types

Other

Identifiers

NCT04274595
AOIGCSMerri/2018/PS-01
2019-002236-91 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment

8 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

8 participants in 1 patient group

Psoriasis patients
Experimental group
Treatment:
Drug: Generic antiretroviral

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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