Role of Reverse Transcriptase Inhibitors in the Treatment of Psoriasis (PSORTI-BIO)
Primary Purpose
Psoriasis
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Generic antiretroviral
Sponsored by

About this trial
This is an interventional treatment trial for Psoriasis
Eligibility Criteria
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
Sites / Locations
- CHU de Montpellier
- CHU de Nimes
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Psoriasis patients
Arm Description
Outcomes
Primary Outcome Measures
Percentage of patients no longer presenting S9.6:D5H6 RNA:DNA duplex
Biopsy screening for S9.6:D5H6 RNA:DNA duplex by immunofluorescence
Percentage of patients no longer presenting S9.6:D5H6 RNA:DNA duplex
Biopsy screening for S9.6:D5H6 RNA:DNA duplex by immunofluorescence
Secondary Outcome Measures
Percentage change in endogenous reverse transcriptase
µUI/mL reverse transcriptase activity tested in serum assayed using CAVIDI HS Mg-RT kit
Percentage change in endogenous reverse transcriptase
µUI/mL reverse transcriptase activity tested in serum assayed using CAVIDI HS Mg-RT kit
Percentage change in Ki67 proliferation marker expression
Percentage of cells positive for Ki67 marker on cutaneous immunohistochemistry
Percentage change in Ki67 proliferation marker expression
Percentage of cells positive for Ki67 marker on cutaneous immunohistochemistry
Percentage change in CK10 differentiation marker expression
Percentage of cells positive for CK10 marker on cutaneous immunohistochemistry
Percentage change in CK10 differentiation marker expression
Percentage of cells positive for CK10 marker on cutaneous immunohistochemistry
Percentage change in filaggrin differentiation marker expression
Percentage of cells positive for filaggrin marker on cutaneous immunohistochemistry
Percentage change in filaggrin differentiation marker expression
Percentage of cells positive for filaggrin marker on cutaneous immunohistochemistry
Percentage change in CD4 inflammation marker expression
Percentage of cells positive for CD4 marker on cutaneous immunohistochemistry
Percentage change in CD4 inflammation marker expression
Percentage of cells positive for CD4 marker on cutaneous immunohistochemistry
Percentage change in CD8 inflammation marker expression
Percentage of cells positive for CD8 marker on cutaneous immunohistochemistry
Percentage change in CD8 inflammation marker expression
Percentage of cells positive for CD8 marker on cutaneous immunohistochemistry
Percentage change in CD11c inflammation marker expression
Percentage of cells positive for CD11c marker on cutaneous immunohistochemistry
Percentage change in CD11c inflammation marker expression
Percentage of cells positive for CD11c marker on cutaneous immunohistochemistry
Average percentage change of Psoriasis Area Severity Index
Scale of four variables of psoriasis severity (minimum score 0 maximum score 72)
Number of side effects
Anticipated side effects = diarrhea, vomiting, nausea, dizziness or headache, feeling weak or rash
Number of side effects
Anticipated side effects = diarrhea, vomiting, nausea, dizziness or headache, feeling weak or rash
Full Information
NCT ID
NCT04274595
First Posted
January 16, 2020
Last Updated
September 27, 2022
Sponsor
Centre Hospitalier Universitaire de Nīmes
1. Study Identification
Unique Protocol Identification Number
NCT04274595
Brief Title
Role of Reverse Transcriptase Inhibitors in the Treatment of Psoriasis
Acronym
PSORTI-BIO
Official Title
Role of Reverse Transcriptase Inhibitors in the Treatment of Psoriasis: A Proof of Biological Concept Test
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
February 13, 2020 (Actual)
Primary Completion Date
November 29, 2021 (Actual)
Study Completion Date
June 20, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nīmes
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Psoriasis patients
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Generic antiretroviral
Intervention Description
200mg emtricitabine plus 245mg tenofovir diisopropyl fumarate for 7 days
Primary Outcome Measure Information:
Title
Percentage of patients no longer presenting S9.6:D5H6 RNA:DNA duplex
Description
Biopsy screening for S9.6:D5H6 RNA:DNA duplex by immunofluorescence
Time Frame
Day 0
Title
Percentage of patients no longer presenting S9.6:D5H6 RNA:DNA duplex
Description
Biopsy screening for S9.6:D5H6 RNA:DNA duplex by immunofluorescence
Time Frame
Day 7
Secondary Outcome Measure Information:
Title
Percentage change in endogenous reverse transcriptase
Description
µUI/mL reverse transcriptase activity tested in serum assayed using CAVIDI HS Mg-RT kit
Time Frame
Day 0
Title
Percentage change in endogenous reverse transcriptase
Description
µUI/mL reverse transcriptase activity tested in serum assayed using CAVIDI HS Mg-RT kit
Time Frame
Day 7
Title
Percentage change in Ki67 proliferation marker expression
Description
Percentage of cells positive for Ki67 marker on cutaneous immunohistochemistry
Time Frame
Day 0
Title
Percentage change in Ki67 proliferation marker expression
Description
Percentage of cells positive for Ki67 marker on cutaneous immunohistochemistry
Time Frame
Day 7
Title
Percentage change in CK10 differentiation marker expression
Description
Percentage of cells positive for CK10 marker on cutaneous immunohistochemistry
Time Frame
Day 0
Title
Percentage change in CK10 differentiation marker expression
Description
Percentage of cells positive for CK10 marker on cutaneous immunohistochemistry
Time Frame
Day 7
Title
Percentage change in filaggrin differentiation marker expression
Description
Percentage of cells positive for filaggrin marker on cutaneous immunohistochemistry
Time Frame
Day 0
Title
Percentage change in filaggrin differentiation marker expression
Description
Percentage of cells positive for filaggrin marker on cutaneous immunohistochemistry
Time Frame
Day 7
Title
Percentage change in CD4 inflammation marker expression
Description
Percentage of cells positive for CD4 marker on cutaneous immunohistochemistry
Time Frame
Day 0
Title
Percentage change in CD4 inflammation marker expression
Description
Percentage of cells positive for CD4 marker on cutaneous immunohistochemistry
Time Frame
Day 7
Title
Percentage change in CD8 inflammation marker expression
Description
Percentage of cells positive for CD8 marker on cutaneous immunohistochemistry
Time Frame
Day 0
Title
Percentage change in CD8 inflammation marker expression
Description
Percentage of cells positive for CD8 marker on cutaneous immunohistochemistry
Time Frame
Day 7
Title
Percentage change in CD11c inflammation marker expression
Description
Percentage of cells positive for CD11c marker on cutaneous immunohistochemistry
Time Frame
Day 0
Title
Percentage change in CD11c inflammation marker expression
Description
Percentage of cells positive for CD11c marker on cutaneous immunohistochemistry
Time Frame
Day 7
Title
Average percentage change of Psoriasis Area Severity Index
Description
Scale of four variables of psoriasis severity (minimum score 0 maximum score 72)
Time Frame
Day 7
Title
Number of side effects
Description
Anticipated side effects = diarrhea, vomiting, nausea, dizziness or headache, feeling weak or rash
Time Frame
Day 7
Title
Number of side effects
Description
Anticipated side effects = diarrhea, vomiting, nausea, dizziness or headache, feeling weak or rash
Time Frame
Day 14
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierre Stoebner
Organizational Affiliation
CHU Nimes
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Montpellier
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
CHU de Nimes
City
Nîmes
ZIP/Postal Code
30029
Country
France
12. IPD Sharing Statement
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Role of Reverse Transcriptase Inhibitors in the Treatment of Psoriasis
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