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

December 3, 2025 updated by: Centre Hospitalier Universitaire de Nīmes

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
8

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Montpellier, France, 34295
        • CHU de Montpellier
      • Nîmes, France, 30029
        • CHU de Nimes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Psoriasis patients
Drug: Generic antiretroviral
200mg emtricitabine plus 245mg tenofovir diisopropyl fumarate for 7 days

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Day 0
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
Day 7

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Day 0
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
Day 7
Percentage change in Ki67 proliferation marker expression
Time Frame: Day 0
Percentage of cells positive for Ki67 marker on cutaneous immunohistochemistry
Day 0
Percentage change in Ki67 proliferation marker expression
Time Frame: Day 7
Percentage of cells positive for Ki67 marker on cutaneous immunohistochemistry
Day 7
Percentage change in CK10 differentiation marker expression
Time Frame: Day 0
Percentage of cells positive for CK10 marker on cutaneous immunohistochemistry
Day 0
Percentage change in CK10 differentiation marker expression
Time Frame: Day 7
Percentage of cells positive for CK10 marker on cutaneous immunohistochemistry
Day 7
Percentage change in filaggrin differentiation marker expression
Time Frame: Day 0
Percentage of cells positive for filaggrin marker on cutaneous immunohistochemistry
Day 0
Percentage change in filaggrin differentiation marker expression
Time Frame: Day 7
Percentage of cells positive for filaggrin marker on cutaneous immunohistochemistry
Day 7
Percentage change in CD4 inflammation marker expression
Time Frame: Day 0
Percentage of cells positive for CD4 marker on cutaneous immunohistochemistry
Day 0
Percentage change in CD4 inflammation marker expression
Time Frame: Day 7
Percentage of cells positive for CD4 marker on cutaneous immunohistochemistry
Day 7
Percentage change in CD8 inflammation marker expression
Time Frame: Day 0
Percentage of cells positive for CD8 marker on cutaneous immunohistochemistry
Day 0
Percentage change in CD8 inflammation marker expression
Time Frame: Day 7
Percentage of cells positive for CD8 marker on cutaneous immunohistochemistry
Day 7
Percentage change in CD11c inflammation marker expression
Time Frame: Day 0
Percentage of cells positive for CD11c marker on cutaneous immunohistochemistry
Day 0
Percentage change in CD11c inflammation marker expression
Time Frame: Day 7
Percentage of cells positive for CD11c marker on cutaneous immunohistochemistry
Day 7
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)
Day 7
Number of side effects
Time Frame: Day 7
Anticipated side effects = diarrhea, vomiting, nausea, dizziness or headache, feeling weak or rash
Day 7
Number of side effects
Time Frame: Day 14
Anticipated side effects = diarrhea, vomiting, nausea, dizziness or headache, feeling weak or rash
Day 14

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Hospitalier Universitaire de Nīmes

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Pierre Stoebner, CHU Nimes

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 13, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 29, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 20, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 16, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 17, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 18, 2020

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 10, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 3, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AOIGCSMerri/2018/PS-01
  • 2019-002236-91 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings