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Completed

NCT Number: NCT04274595

Role of Reverse Transcriptase Inhibitors in the Treatment of Psoriasis

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

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Montpellier, Montpellier, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Generic antiretroviral

Drug

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

Primary outcomes

  1. Percentage of patients no longer presenting S9.6:D5H6 RNA:DNA duplex

    Time frame: Day 0

    Biopsy screening for S9.6:D5H6 RNA:DNA duplex by immunofluorescence

  2. Percentage of patients no longer presenting S9.6:D5H6 RNA:DNA duplex

    Time frame: Day 7

    Biopsy screening for S9.6:D5H6 RNA:DNA duplex by immunofluorescence

Secondary outcomes

  1. Percentage change in endogenous reverse transcriptase

    Time frame: Day 0

    µUI/mL reverse transcriptase activity tested in serum assayed using CAVIDI HS Mg-RT kit

  2. Percentage change in endogenous reverse transcriptase

    Time frame: Day 7

    µUI/mL reverse transcriptase activity tested in serum assayed using CAVIDI HS Mg-RT kit

  3. Percentage change in Ki67 proliferation marker expression

    Time frame: Day 0

    Percentage of cells positive for Ki67 marker on cutaneous immunohistochemistry

  4. Percentage change in Ki67 proliferation marker expression

    Time frame: Day 7

    Percentage of cells positive for Ki67 marker on cutaneous immunohistochemistry

  5. Percentage change in CK10 differentiation marker expression

    Time frame: Day 0

    Percentage of cells positive for CK10 marker on cutaneous immunohistochemistry

  6. Percentage change in CK10 differentiation marker expression

    Time frame: Day 7

    Percentage of cells positive for CK10 marker on cutaneous immunohistochemistry

  7. Percentage change in filaggrin differentiation marker expression

    Time frame: Day 0

    Percentage of cells positive for filaggrin marker on cutaneous immunohistochemistry

  8. Percentage change in filaggrin differentiation marker expression

    Time frame: Day 7

    Percentage of cells positive for filaggrin marker on cutaneous immunohistochemistry

  9. Percentage change in CD4 inflammation marker expression

    Time frame: Day 0

    Percentage of cells positive for CD4 marker on cutaneous immunohistochemistry

  10. Percentage change in CD4 inflammation marker expression

    Time frame: Day 7

    Percentage of cells positive for CD4 marker on cutaneous immunohistochemistry

  11. Percentage change in CD8 inflammation marker expression

    Time frame: Day 0

    Percentage of cells positive for CD8 marker on cutaneous immunohistochemistry

  12. Percentage change in CD8 inflammation marker expression

    Time frame: Day 7

    Percentage of cells positive for CD8 marker on cutaneous immunohistochemistry

  13. Percentage change in CD11c inflammation marker expression

    Time frame: Day 0

    Percentage of cells positive for CD11c marker on cutaneous immunohistochemistry

  14. Percentage change in CD11c inflammation marker expression

    Time frame: Day 7

    Percentage of cells positive for CD11c marker on cutaneous immunohistochemistry

  15. Average percentage change of Psoriasis Area Severity Index

    Time frame: Day 7

    Scale of four variables of psoriasis severity (minimum score 0 maximum score 72)

  16. Number of side effects

    Time frame: Day 7

    Anticipated side effects = diarrhea, vomiting, nausea, dizziness or headache, feeling weak or rash

  17. Number of side effects

    Time frame: Day 14

    Anticipated side effects = diarrhea, vomiting, nausea, dizziness or headache, feeling weak or rash

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Official study title

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

Acronym: PSORTI-BIO

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Feb 18, 2020
Registry last updated
Dec 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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