Topical Isotretinoin (TMB-001) Treatment for 12 Weeks Did Not Result in Clinically Relevant Laboratory Abnormalities in Participants with Congenital Ichthyosis in the Phase 2b CONTROL Study
Marathe K, Teng J, Guenthner S, Bunick C, Kempers S, Eads K, Castelo-Soccio L, Mendelsohn A, Raiz J, Murrell D. Topical Isotretinoin (TMB-001) Treatment for 12 Weeks Did Not Result in Clinically Relevant Laboratory Abnormalities in Participants with Congenital Ichthyosis in the Phase 2b CONTROL Study. Dermatology And Therapy 2023, 13: 1255-1264. PMID: 37170057, PMCID: PMC10264299, DOI: 10.1007/s13555-023-00923-1.Peer-Reviewed Original ResearchSignificant laboratory changesLaboratory changesCongenital ichthyosisLaboratory parameter changesRelevant laboratory abnormalitiesPhase 2b studyWeeks of treatmentYears of ageSingle reportCI subtypesIsotretinoin treatmentStudy discontinuationSystemic isotretinoinUrinalysis abnormalitiesLaboratory abnormalitiesOral retinoidsTreatment cohortsVehicle treatmentDrug withdrawalLaboratory valuesLeukocyte esteraseUrea nitrogenControl studyWeeksNeutropeniaCharacteristics and outcomes for participants with congenital ichthyosis who responded to treatment with the topical isotretinoin formulation TMB-001: results from the Phase IIb CONTROL study
Bunick C, Teng J, Guenthner S, Marathe K, Kempers S, Eads K, Castelo-Soccio L, Mendelsohn A, Raiz J, Murrell D. Characteristics and outcomes for participants with congenital ichthyosis who responded to treatment with the topical isotretinoin formulation TMB-001: results from the Phase IIb CONTROL study. Clinical And Experimental Dermatology 2023, 48: 765-769. PMID: 36928932, DOI: 10.1093/ced/llad105.Peer-Reviewed Original ResearchConceptsBSA involvementCongenital ichthyosisHigher DLQIIgA responsesTreatment successControl studyDermatology Life Quality Index scoresBody surface area involvementDose-limiting adverse effectGlobal assessmentLife Quality Index scoresInvestigator's Global AssessmentSurface area involvementProportion of participantsRating Scale scoresSystemic retinoid treatmentYears of ageQuality Index scoresCharacteristics of participantsIgA respondersBaseline demographicsEfficacy endpointMedian ageArea involvementScale score