Role of Reverse Transcriptase Inhibitors in the Treatment of Psoriasis
PSORTI-BIO
2 other identifiers
interventional
8
1 country
2
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2020
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 16, 2020
CompletedStudy Start
First participant enrolled
February 13, 2020
CompletedFirst Posted
Study publicly available on registry
February 18, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 29, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 20, 2022
CompletedDecember 10, 2025
December 1, 2025
1.8 years
January 16, 2020
December 3, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Percentage of patients no longer presenting S9.6:D5H6 RNA:DNA duplex
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
Biopsy screening for S9.6:D5H6 RNA:DNA duplex by immunofluorescence
Day 7
Secondary Outcomes (17)
Percentage change in endogenous reverse transcriptase
Day 0
Percentage change in endogenous reverse transcriptase
Day 7
Percentage change in Ki67 proliferation marker expression
Day 0
Percentage change in Ki67 proliferation marker expression
Day 7
Percentage change in CK10 differentiation marker expression
Day 0
- +12 more secondary outcomes
Study Arms (1)
Psoriasis patients
EXPERIMENTALInterventions
200mg emtricitabine plus 245mg tenofovir diisopropyl fumarate for 7 days
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Patient with another form or stage of psoriasis
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
CHU de Montpellier
Montpellier, 34295, France
CHU de Nimes
Nîmes, 30029, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pierre Stoebner
CHU Nimes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 16, 2020
First Posted
February 18, 2020
Study Start
February 13, 2020
Primary Completion
November 29, 2021
Study Completion
June 20, 2022
Last Updated
December 10, 2025
Record last verified: 2025-12