PsoriasisPSORTI-BIONCT04274595
Role of Reverse Transcriptase Inhibitors in the Treatment of Psoriasis
A study testing Generic antiretroviral in people with Psoriasis, run by Centre Hospitalier Universitaire de Nīmes at 2 sites in France.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Psoriasis
- What is being tested?
- Generic antiretroviral
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 2 sitesFrance
- Study dates
- 13 Feb 2020to 20 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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 locations and contacts
2 sites in 1 country.
About this study
Official title: 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
- Conditions
- Psoriasis
- Being tested
- Generic antiretroviral
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Generic antiretroviralDrug
200mg emtricitabine plus 245mg tenofovir diisopropyl fumarate for 7 days
| Study group | Role | What they receive |
|---|---|---|
| Psoriasis patients | Experimental | Not described Receives: Drug: Generic antiretroviral |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients no longer presenting S9.6:D5H6 RNA:DNA duplex
Biopsy screening for S9.6:D5H6 RNA:DNA duplex by immunofluorescence
Measured: Day 0
Percentage of patients no longer presenting S9.6:D5H6 RNA:DNA duplex
Biopsy screening for S9.6:D5H6 RNA:DNA duplex by immunofluorescence
Measured: Day 7
Secondary outcomes (17)
Percentage change in endogenous reverse transcriptase
µUI/mL reverse transcriptase activity tested in serum assayed using CAVIDI HS Mg-RT kit
Measured: Day 0
Percentage change in endogenous reverse transcriptase
µUI/mL reverse transcriptase activity tested in serum assayed using CAVIDI HS Mg-RT kit
Measured: Day 7
Percentage change in Ki67 proliferation marker expression
Percentage of cells positive for Ki67 marker on cutaneous immunohistochemistry
Measured: Day 0
Percentage change in Ki67 proliferation marker expression
Percentage of cells positive for Ki67 marker on cutaneous immunohistochemistry
Measured: Day 7
Percentage change in CK10 differentiation marker expression
Percentage of cells positive for CK10 marker on cutaneous immunohistochemistry
Measured: Day 0
Percentage change in CK10 differentiation marker expression
Percentage of cells positive for CK10 marker on cutaneous immunohistochemistry
Measured: Day 7
Percentage change in filaggrin differentiation marker expression
Percentage of cells positive for filaggrin marker on cutaneous immunohistochemistry
Measured: Day 0
Percentage change in filaggrin differentiation marker expression
Percentage of cells positive for filaggrin marker on cutaneous immunohistochemistry
Measured: Day 7
Percentage change in CD4 inflammation marker expression
Percentage of cells positive for CD4 marker on cutaneous immunohistochemistry
Measured: Day 0
Percentage change in CD4 inflammation marker expression
Percentage of cells positive for CD4 marker on cutaneous immunohistochemistry
Measured: Day 7
Percentage change in CD8 inflammation marker expression
Percentage of cells positive for CD8 marker on cutaneous immunohistochemistry
Measured: Day 0
Percentage change in CD8 inflammation marker expression
Percentage of cells positive for CD8 marker on cutaneous immunohistochemistry
Measured: Day 7
Percentage change in CD11c inflammation marker expression
Percentage of cells positive for CD11c marker on cutaneous immunohistochemistry
Measured: Day 0
Percentage change in CD11c inflammation marker expression
Percentage of cells positive for CD11c marker on cutaneous immunohistochemistry
Measured: Day 7
Average percentage change of Psoriasis Area Severity Index
Scale of four variables of psoriasis severity (minimum score 0 maximum score 72)
Measured: Day 7
Number of side effects
Anticipated side effects = diarrhea, vomiting, nausea, dizziness or headache, feeling weak or rash
Measured: Day 7
Number of side effects
Anticipated side effects = diarrhea, vomiting, nausea, dizziness or headache, feeling weak or rash
Measured: Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2020
- Study start13 Feb 2020
- Primary completion29 Nov 2021
- Study completion20 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre Stoebner, Principal investigator, CHU Nimes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04274595
- Sponsor's protocol ID
- AOIGCSMerri/2018/PS-01
- Other IDs
- 2019-002236-91, 2019
- Acronym
- PSORTI-BIO
- Status last verified
- Dec 2025
- First submitted
- 16 Jan 2020
- Last updated
- 10 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Reverse Transcriptase Inhibitors in the Treatment of Psoriasis: A Proof of Biological Concept Test
- ClinicalTrials.gov ID
- NCT04274595
- Acronym / sponsor ID
- PSORTI-BIO / AOIGCSMerri/2018/PS-01
- Conditions
- Psoriasis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 13 Feb 2020 (actual)
- Primary completion
- 29 Nov 2021 (actual)
- Study completion
- 20 Jun 2022 (actual)
- First posted
- 18 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Psoriasis patients | Experimental | Drug: Generic antiretroviral |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Generic antiretroviral200mg emtricitabine plus 245mg tenofovir diisopropyl fumarate for 7 days | Drug | Psoriasis patients |
Primary outcome
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
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
17 secondary outcomes
Percentage change in endogenous reverse transcriptase
Time frame: Day 0
Percentage change in endogenous reverse transcriptase
Time frame: Day 7
Percentage change in Ki67 proliferation marker expression
Time frame: Day 0
Percentage change in Ki67 proliferation marker expression
Time frame: Day 7
Percentage change in CK10 differentiation marker expression
Time frame: Day 0
Percentage change in CK10 differentiation marker expression
Time frame: Day 7
Percentage change in filaggrin differentiation marker expression
Time frame: Day 0
Percentage change in filaggrin differentiation marker expression
Time frame: Day 7
Percentage change in CD4 inflammation marker expression
Time frame: Day 0
Percentage change in CD4 inflammation marker expression
Time frame: Day 7
Percentage change in CD8 inflammation marker expression
Time frame: Day 0
Percentage change in CD8 inflammation marker expression
Time frame: Day 7
Percentage change in CD11c inflammation marker expression
Time frame: Day 0
Percentage change in CD11c inflammation marker expression
Time frame: Day 7
Average percentage change of Psoriasis Area Severity Index
Time frame: Day 7
Number of side effects
Time frame: Day 7
Number of side effects
Time frame: Day 14
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierre Stoebner principal investigator
CHU Nimes
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Generic antiretroviral in people with Psoriasis, run by Centre Hospitalier Universitaire de Nīmes at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients no longer presenting S9.6:D5H6 RNA:DNA duplex (time frame: Day 0). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2025.