Ignite Creation Date:
2025-12-24 @ 1:35 PM
Ignite Modification Date:
2025-12-30 @ 7:22 AM
Study NCT ID:
NCT04274595
Status:
COMPLETED
Last Update Posted:
2025-12-10
First Post:
2020-01-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Role of Reverse Transcriptase Inhibitors in the Treatment of Psoriasis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011565', 'term': 'Psoriasis'}], 'ancestors': [{'id': 'D017444', 'term': 'Skin Diseases, Papulosquamous'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-02-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2022-06-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-03', 'studyFirstSubmitDate': '2020-01-16', 'studyFirstSubmitQcDate': '2020-02-17', 'lastUpdatePostDateStruct': {'date': '2025-12-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2020-02-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of patients no longer presenting S9.6:D5H6 RNA:DNA duplex', 'timeFrame': 'Day 0', 'description': 'Biopsy screening for S9.6:D5H6 RNA:DNA duplex by immunofluorescence'}, {'measure': 'Percentage of patients no longer presenting S9.6:D5H6 RNA:DNA duplex', 'timeFrame': 'Day 7', 'description': 'Biopsy screening for S9.6:D5H6 RNA:DNA duplex by immunofluorescence'}], 'secondaryOutcomes': [{'measure': 'Percentage change in endogenous reverse transcriptase', 'timeFrame': 'Day 0', 'description': 'µUI/mL reverse transcriptase activity tested in serum assayed using CAVIDI HS Mg-RT kit'}, {'measure': 'Percentage change in endogenous reverse transcriptase', 'timeFrame': 'Day 7', 'description': 'µUI/mL reverse transcriptase activity tested in serum assayed using CAVIDI HS Mg-RT kit'}, {'measure': 'Percentage change in Ki67 proliferation marker expression', 'timeFrame': 'Day 0', 'description': 'Percentage of cells positive for Ki67 marker on cutaneous immunohistochemistry'}, {'measure': 'Percentage change in Ki67 proliferation marker expression', 'timeFrame': 'Day 7', 'description': 'Percentage of cells positive for Ki67 marker on cutaneous immunohistochemistry'}, {'measure': 'Percentage change in CK10 differentiation marker expression', 'timeFrame': 'Day 0', 'description': 'Percentage of cells positive for CK10 marker on cutaneous immunohistochemistry'}, {'measure': 'Percentage change in CK10 differentiation marker expression', 'timeFrame': 'Day 7', 'description': 'Percentage of cells positive for CK10 marker on cutaneous immunohistochemistry'}, {'measure': 'Percentage change in filaggrin differentiation marker expression', 'timeFrame': 'Day 0', 'description': 'Percentage of cells positive for filaggrin marker on cutaneous immunohistochemistry'}, {'measure': 'Percentage change in filaggrin differentiation marker expression', 'timeFrame': 'Day 7', 'description': 'Percentage of cells positive for filaggrin marker on cutaneous immunohistochemistry'}, {'measure': 'Percentage change in CD4 inflammation marker expression', 'timeFrame': 'Day 0', 'description': 'Percentage of cells positive for CD4 marker on cutaneous immunohistochemistry'}, {'measure': 'Percentage change in CD4 inflammation marker expression', 'timeFrame': 'Day 7', 'description': 'Percentage of cells positive for CD4 marker on cutaneous immunohistochemistry'}, {'measure': 'Percentage change in CD8 inflammation marker expression', 'timeFrame': 'Day 0', 'description': 'Percentage of cells positive for CD8 marker on cutaneous immunohistochemistry'}, {'measure': 'Percentage change in CD8 inflammation marker expression', 'timeFrame': 'Day 7', 'description': 'Percentage of cells positive for CD8 marker on cutaneous immunohistochemistry'}, {'measure': 'Percentage change in CD11c inflammation marker expression', 'timeFrame': 'Day 0', 'description': 'Percentage of cells positive for CD11c marker on cutaneous immunohistochemistry'}, {'measure': 'Percentage change in CD11c inflammation marker expression', 'timeFrame': 'Day 7', 'description': 'Percentage of cells positive for CD11c marker on cutaneous immunohistochemistry'}, {'measure': 'Average percentage change of Psoriasis Area Severity Index', 'timeFrame': 'Day 7', 'description': 'Scale of four variables of psoriasis severity (minimum score 0 maximum score 72)'}, {'measure': 'Number of side effects', 'timeFrame': 'Day 7', 'description': 'Anticipated side effects = diarrhea, vomiting, nausea, dizziness or headache, feeling weak or rash'}, {'measure': 'Number of side effects', 'timeFrame': 'Day 14', 'description': 'Anticipated side effects = diarrhea, vomiting, nausea, dizziness or headache, feeling weak or rash'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Psoriasis']}, 'descriptionModule': {'briefSummary': '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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient suffering from plaque psoriasis for more than a year with at least one active skin lesion\\> 4 cm2 in the photo-protected area.\n* Patient using effective contraception (IUD, adapted pill, condom, etc.)\n* The patient must have given their free and informed consent and signed the consent form\n* The patient must be a member or beneficiary of a health insurance plan\n\nExclusion Criteria:\n\n* Patient with another form or stage of psoriasis\n* Patient on anti-cytokine treatment during the 6 months (180 days) before inclusion\n* 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\n* Patient on topical corticosteroid or retinoid treatment during the 2 weeks (15 days) before inclusion\n* 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).\n* Patient with active viral infection (HBV, HCV and HIV), or uncontrolled acute infection.\n* Patient with hypersensitivity to one of the active substances or to any of the excipients (non-medicinal ingredients).\n* Patient with uncontrolled coagulation disorder, history of keloid scars\n* 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\n* 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'}, 'identificationModule': {'nctId': 'NCT04274595', 'acronym': 'PSORTI-BIO', 'briefTitle': 'Role of Reverse Transcriptase Inhibitors in the Treatment of Psoriasis', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Nīmes'}, 'officialTitle': 'Role of Reverse Transcriptase Inhibitors in the Treatment of Psoriasis: A Proof of Biological Concept Test', 'orgStudyIdInfo': {'id': 'AOIGCSMerri/2018/PS-01'}, 'secondaryIdInfos': [{'id': '2019-002236-91', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Psoriasis patients', 'interventionNames': ['Drug: Generic antiretroviral']}], 'interventions': [{'name': 'Generic antiretroviral', 'type': 'DRUG', 'description': '200mg emtricitabine plus 245mg tenofovir diisopropyl fumarate for 7 days', 'armGroupLabels': ['Psoriasis patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34295', 'city': 'Montpellier', 'country': 'France', 'facility': 'CHU de Montpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '30029', 'city': 'Nîmes', 'country': 'France', 'facility': 'CHU de Nimes', 'geoPoint': {'lat': 43.83665, 'lon': 4.35788}}], 'overallOfficials': [{'name': 'Pierre Stoebner', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU Nimes'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Nīmes', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}