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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-002236-91 | EudraCT Number |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Psoriasis patients | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Generic antiretroviral | Drug | 200mg emtricitabine plus 245mg tenofovir diisopropyl fumarate for 7 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage change in endogenous reverse transcriptase | µUI/mL reverse transcriptase activity tested in serum assayed using CAVIDI HS Mg-RT kit | Day 0 |
| Percentage change in endogenous reverse transcriptase |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pierre Stoebner | CHU Nimes | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Montpellier | Montpellier | 34295 | France | |||
| CHU de Nimes |
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| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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µUI/mL reverse transcriptase activity tested in serum assayed using CAVIDI HS Mg-RT kit
| Day 7 |
| Percentage change in Ki67 proliferation marker expression | Percentage of cells positive for Ki67 marker on cutaneous immunohistochemistry | Day 0 |
| Percentage change in Ki67 proliferation marker expression | Percentage of cells positive for Ki67 marker on cutaneous immunohistochemistry | Day 7 |
| Percentage change in CK10 differentiation marker expression | Percentage of cells positive for CK10 marker on cutaneous immunohistochemistry | Day 0 |
| Percentage change in CK10 differentiation marker expression | Percentage of cells positive for CK10 marker on cutaneous immunohistochemistry | Day 7 |
| Percentage change in filaggrin differentiation marker expression | Percentage of cells positive for filaggrin marker on cutaneous immunohistochemistry | Day 0 |
| Percentage change in filaggrin differentiation marker expression | Percentage of cells positive for filaggrin marker on cutaneous immunohistochemistry | Day 7 |
| Percentage change in CD4 inflammation marker expression | Percentage of cells positive for CD4 marker on cutaneous immunohistochemistry | Day 0 |
| Percentage change in CD4 inflammation marker expression | Percentage of cells positive for CD4 marker on cutaneous immunohistochemistry | Day 7 |
| Percentage change in CD8 inflammation marker expression | Percentage of cells positive for CD8 marker on cutaneous immunohistochemistry | Day 0 |
| Percentage change in CD8 inflammation marker expression | Percentage of cells positive for CD8 marker on cutaneous immunohistochemistry | Day 7 |
| Percentage change in CD11c inflammation marker expression | Percentage of cells positive for CD11c marker on cutaneous immunohistochemistry | Day 0 |
| Percentage change in CD11c inflammation marker expression | Percentage of cells positive for CD11c marker on cutaneous immunohistochemistry | Day 7 |
| Average percentage change of Psoriasis Area Severity Index | Scale of four variables of psoriasis severity (minimum score 0 maximum score 72) | Day 7 |
| Number of side effects | Anticipated side effects = diarrhea, vomiting, nausea, dizziness or headache, feeling weak or rash | Day 7 |
| Number of side effects | Anticipated side effects = diarrhea, vomiting, nausea, dizziness or headache, feeling weak or rash | Day 14 |
| Nîmes |
| 30029 |
| France |