2023
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 studyWeeksNeutropenia
2022
The CONTROL study: A randomized, double-blind vehicle-controlled phase 2b study of novel topical isotretinoin formulation demonstrates improvement in recessive X-linked and autosomal recessive lamellar congenital ichthyosis
Teng JMC, Bunick CG, Guenthner S, Murrell DF, Marathe K, Kempers S, Eads K, Mendelsohn AM, Raiz J, Tavakkol A, Castelo-Soccio L. The CONTROL study: A randomized, double-blind vehicle-controlled phase 2b study of novel topical isotretinoin formulation demonstrates improvement in recessive X-linked and autosomal recessive lamellar congenital ichthyosis. Journal Of The American Academy Of Dermatology 2022, 87: 1455-1458. PMID: 35872261, DOI: 10.1016/j.jaad.2022.07.028.Peer-Reviewed Original Research