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
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 scorePhase 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
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 ResearchSafety, tolerability, and efficacy of a novel topical isotretinoin formulation for the treatment of X-linked or lamellar congenital ichthyosis: Results from a phase 2a proof-of-concept study
Paller AS, Browning J, Parish LC, Bunick CG, Rome Z, Bhatia N. Safety, tolerability, and efficacy of a novel topical isotretinoin formulation for the treatment of X-linked or lamellar congenital ichthyosis: Results from a phase 2a proof-of-concept study. Journal Of The American Academy Of Dermatology 2022, 87: 1189-1191. PMID: 35271936, DOI: 10.1016/j.jaad.2022.02.060.Peer-Reviewed Original Research