[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100543943":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":35,"responsibleParty":67,"collaborators":20,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":71,"sex":77,"minAge":78,"maxAge":79,"enrollmentInfo":80,"targetDuration":20,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":89,"overallStatus":92,"whyStopped":20,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"University Hospital, Toulouse","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Gentamicin","EXPERIMENTAL","Gentamicin injection",[13],"Drug: Gentamicin Injectable Solution",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Gentamicin Injectable Solution","Gentamicin (10 mg\u002Fkg) will be administrated once weekly for 3 months",[9],null,[22],{"name":23,"affiliation":5,"role":24},"SEVERINO-FREIRE Maella, MD","PRINCIPAL_INVESTIGATOR",[26,31],{"name":23,"role":27,"phone":28,"phoneExt":29,"email":30},"CONTACT","05 67 77 81 41","33","severino-freire.m@chu-toulouse.fr",{"name":32,"role":27,"phone":33,"phoneExt":29,"email":34},"TEXIER Hélène","05 67 77 81 80","texier.h@chu-toulouse.fr",[36,53],{"facility":37,"status":20,"city":38,"state":39,"zip":40,"country":39,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"Hôpital Saint-Louis APHP","Paris","France","75010","FR",{"type":43,"coordinates":44},"Point",[45,46],2.3488,48.85341,{"lat":46,"lon":45},[49],{"name":50,"role":27,"phone":51,"phoneExt":29,"email":52},"BOURRAT Emmanuelle, MD","01 42 49 90 90","emmanuelle.bourrat@aphp.fr",{"facility":54,"status":20,"city":55,"state":39,"zip":56,"country":39,"countryCode":41,"cosmosGeoPoint":57,"geoPoint":61,"contacts":62},"CHU de Toulouse","Toulouse","31059",{"type":43,"coordinates":58},[59,60],1.44367,43.60426,{"lat":60,"lon":59},[63,64,65],{"name":23,"role":27,"phone":28,"phoneExt":29,"email":30},{"name":32,"role":27,"phone":33,"phoneExt":29,"email":34},{"name":66,"role":27,"phone":20,"phoneExt":20,"email":20},"MAZEREEUW-HAUTIER Juliette, MD, PhD",{"type":68,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100543943","phase-2-efficacy-of-injectable-gentamicin-in-hereditary-ichthyosis-100543943",false,"NCT06362447","Efficacy of Injectable Gentamicin in Hereditary Ichthyosis","Phase 2 Study Evaluating the Efficacy of Injectable Gentamicin in Hereditary Ichthyosis","GENTIC","Inclusion Criteria:\n\n1. Adult patients affiliated to a social insurance protection regimen.\n2. Hereditary ichthyosis caused by a homozygous non-sense mutation of a gene responsible for hereditary ichthyosis (TGM1, PNPLA1, ALOX12B, NIPAL4, ALOXE3, SDR9C7, ABCA12, CERS3, SPINK5 and CDSN)\n3. Moderate to severe forms of ichthyosis defined as Validating an Ichthyosis Severity Index score at 2-3 on at least 2 out of 4 areas evaluated (back, upper limbs, lower limbs, back of the foot)\n4. Free, informed consent, written and signed by the participant and the investigator (at the latest on the day of inclusion and before any examination required by the research).\n\nExclusion Criteria:\n\n1. Cutaneous signs suggesting a surinfection\n2. Hypersensibility of active substance or one of the gentamicin excipients\n3. Administration of an aminoside in the previous 3 months\n4. Treatment with nephrotoxic or ototoxic medication in the previous 6 weeks\n5. Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study. Women of childbearing age, potentially sexually active, and unwilling to use acceptable contraception measures in accordance with Clinical Trials Facilitation and Coordination Group recommendations\n6. Subjects \\>75 years (physiological impairment of kidney function)\n7. Left ventricular insufficiency\n8. Hypoalbuminemia\n9. Myasthenia\n10. History of necrosis at the injection site during previous treatment with aminosid\n11. Grade B or C cirrhosis according to Child-Pugh classification\n12. Nephropathy or other situation at risk of renal dysfunction\n13. Renal insufficiency with glomerular filtration rate \\\u003C 60mL\u002Fmin\n14. Surdity which is not caused by plug scales in the external ear canals or other situation at risk of surdity including the presence of the A1555G mutation in the 12S ribonucleic acid (mitochondrial deoxyribonucleic acid) gene\n15. Patient who modify his keratolytic or emollient treatment in the last two weeks previous the inclusion visit\n16. Patient who modify his retinoid topic treatment in the month previous the inclusion visit\n17. Patient who modify his systemic retinoid treatment in the 3 months previous the inclusion visit\n18. Patient under guardianship, curatorship or deprived of their liberty\n19. Patient with pre-existing neuromuscular disease\n20. Patient participating in another clinical study with investigational treatment\n\nExclusion criteria at the end of the \"run-in\" period:\n\nVariation greater than 15% in the Validating an Ichthyosis Severity Index score between two baseline measurements.","ALL","18 Years","75 Years",{"count":81,"type":82},26,"ESTIMATED","INTERVENTIONAL",[85],"PHASE2","This study will evaluate the efficacy and safety of intravenous gentamicin in congenital ichthyosis due to a non-sens mutation. The primary objective is the severity of scales and erythema at the third month, compared to baseline. Secondary objectives will include: the importance of itching, trans epidermal water loss, cutaneous expression of the targeted protein, the security of the drug and patients' satisfaction.",[88],"Ichthyosis",[90,91],"Congenital ichthyoses","injectable gentamicin","NOT_YET_RECRUITING","2024-08-30",{"date":95,"type":96},"2024-09-05","ACTUAL",{"date":98,"type":82},"2024-09",{"date":100,"type":82},"2027-04-01",{"name":5,"class":6},2]