2024
51523 The Phase 3 Vehicle-Controlled ASCEND Trial of Polyethylene Glycol Based Topical Isotretinoin (TMB-001 0.05% ointment) for Treatment of X-Linked and Autosomal Recessive Congenital Ichthyosis: Pharmacokinetic Results Compared with 80 mg Oral Isotretinoin
Bunick C, Huynh T, Jackson M, Lee L, Kempers S, Mendelsohn A, Eursken B, Ahson A, Raiz J, MC. Teng J. 51523 The Phase 3 Vehicle-Controlled ASCEND Trial of Polyethylene Glycol Based Topical Isotretinoin (TMB-001 0.05% ointment) for Treatment of X-Linked and Autosomal Recessive Congenital Ichthyosis: Pharmacokinetic Results Compared with 80 mg Oral Isotretinoin. Journal Of The American Academy Of Dermatology 2024, 91: ab332. DOI: 10.1016/j.jaad.2024.07.1321.Peer-Reviewed Original Research
2023
Phase IIb randomized CONTROL study demonstrates a novel topical isotretinoin formulation, TMB-001, is safe and effective in participants with either recessive X-linked or autosomal recessive lamellar congenital ichthyosis
Murrell D, Teng J, Guenthner S, Marathe K, Kempers S, Eads K, Castelo-Soccio L, Mendelsohn A, Raiz J, Bunick C. Phase IIb randomized CONTROL study demonstrates a novel topical isotretinoin formulation, TMB-001, is safe and effective in participants with either recessive X-linked or autosomal recessive lamellar congenital ichthyosis. Clinical And Experimental Dermatology 2023, 48: 623-630. PMID: 36794376, DOI: 10.1093/ced/llad033.Peer-Reviewed Original ResearchConceptsAdverse eventsVehicle groupControl studyGlobal assessmentInvestigator's Global AssessmentMost adverse eventsApplication site reactionsTopical treatment optionsProportion of participantsIGA scoreCutaneous manifestationsMean agePhase IIbTreatment optionsCongenital ichthyosisSubtypesAutosomal recessive lamellar ichthyosisOintment formulationLamellar ichthyosisRecessive ichthyosisIchthyosisScoresBaselineGreater proportionParticipants