2024
Clindamycin Phosphate 1.2%/Adapalene 0.15%/Benzoyl Peroxide 3.1% Gel for Male and Female Acne: Phase 3 Analysis.
Lain E, Bhatia N, Kircik L, Gold L, Harper J, Bunick C, Guenin E, Baldwin H, Feldman S, Rosso J. Clindamycin Phosphate 1.2%/Adapalene 0.15%/Benzoyl Peroxide 3.1% Gel for Male and Female Acne: Phase 3 Analysis. Journal Of Drugs In Dermatology 2024, 23: 873-881. PMID: 39361705, DOI: 10.36849/jdd.2024.8484.Peer-Reviewed Original ResearchConceptsTreatment-emergent adverse eventsModerate-to-severe acneWeeks of once-daily treatmentInflammatory/noninflammatory lesion countsMild to moderate severityTriple-combination treatmentOnce-daily treatmentBaseline to weekPhase 3 studyTreatment success rateQuality-of-life improvementAcne-specific quality of lifePost hoc analysisCutaneous safety/tolerabilityFixed-doseVehicle gelDouble-blindNoninflammatory lesionsFemale acneNo significant differenceImpact of sexEfficacy measuresLesion countsAdverse eventsTreatment success734 - Efficacy and safety of upadacitinib vs dupliumab in adults and adolescents with moderate-to-severe atopic dermatitis: results of an open-label, efficacy assessor-blinded head-to-head phase 3b/4 study (Level Up)
Silverberg J, Bunick C, Hong H, Mendes-Bastos P, Gold L, Costanzo A, Ibrahim N, Sancho C, Wu X, Han Y, Levy G, Altman K, Eyerich K. 734 - Efficacy and safety of upadacitinib vs dupliumab in adults and adolescents with moderate-to-severe atopic dermatitis: results of an open-label, efficacy assessor-blinded head-to-head phase 3b/4 study (Level Up). British Journal Of Dermatology 2024, 191: ljae266.107. DOI: 10.1093/bjd/ljae266.107.Peer-Reviewed Original ResearchSafety of upadacitinibVenous thromboembolic eventsProportion of patientsAdverse eventsAtopic dermatitisDose escalationSystemic therapyOpen-labelSecondary endpointsAdjudicated major adverse cardiac eventsModerate-to-severe atopic dermatitisResponse to systemic therapyTreatment-emergent adverse eventsWeek 4Major adverse cardiac eventsPruritus Numerical Rating ScaleChronic inflammatory skin diseaseDiscontinuation of study treatmentEczematous skin lesionsOral Janus kinaseSevere adverse eventsAdverse cardiac eventsWeeks of treatmentNumerical rating scaleInflammatory skin disease640 - Investigator- and patient-rated local tolerability in phase 3 trials of topical roflumilast in patients with psoriasis, seborrheic dermatitis, and atopic dermatitis
Bunick C, Bhatia N, Del Rosso J, Draelos Z, Eichenfield L, Kircik L, Lebwohl M, Gooderham M, Green L, Hebert A, Vender R, Zirwas M, Simpson E, Gold L, Seal M, Snyder S, Osborne D, Burnett P, Higham R, Chu D, Berk D. 640 - Investigator- and patient-rated local tolerability in phase 3 trials of topical roflumilast in patients with psoriasis, seborrheic dermatitis, and atopic dermatitis. British Journal Of Dermatology 2024, 191: ljae266.021. DOI: 10.1093/bjd/ljae266.021.Peer-Reviewed Original ResearchPhase 3 trialLocal tolerancePatient treatment adherenceAdverse eventsAtopic dermatitisSeborrheic dermatitisPenetration enhancersRoflumilast-treated patientsRate of adverse eventsTreatment adherencePatient-rated assessmentsApplication siteTopical medicationsIntertriginous areasRoflumilast creamDay 1Water-based creamRoflumilastInvestigational productPatientsInvestigator-PsoriasisDermatitisPrescription productsTrialsTriple Combination Clindamycin Phosphate 1.2%/Adapalene 0.15%/Benzoyl Peroxide 3.1% for Acne: Efficacy and Safety from a Pooled Phase 3 Analysis
Kircik L, Stein Gold L, Gold M, Weiss J, Harper J, Del Rosso J, Bunick C, Bhatia N, Tanghetti E, Eichenfield L, Baldwin H, Draelos Z, Callender V, Han G, Gooderham M, Sadick N, Lupo M, Lain E, Werschler W. Triple Combination Clindamycin Phosphate 1.2%/Adapalene 0.15%/Benzoyl Peroxide 3.1% for Acne: Efficacy and Safety from a Pooled Phase 3 Analysis. Dermatology And Therapy 2024, 14: 1211-1227. PMID: 38724841, PMCID: PMC11116301, DOI: 10.1007/s13555-024-01155-7.Peer-Reviewed Original ResearchTreatment-emergent adverse eventsModerate-to-severe acneClear/almost clear skinTopical acne productsFixed-doseVehicle gelClear skinAcne productsLeast-squares mean percent changesTreatment successEvaluator's Global Severity ScoreIdentical phase 3Acne lesion countsMild-moderate severityGlobal severity scoreReduce antibiotic resistanceNear baseline valuesCutaneous safety/tolerabilityDouble-blindNoninflammatory lesionsResultsAt weekLesion countsAdverse eventsClinical studiesAcne treatment533 - Long-term 5-year safety of upadacitinib in moderate-to-severe atopic dermatitis: an integrated analysis including over 7000 patient-years of exposure
Bunick C, Chovatiya R, Guttman E, Shahriari M, Boguniewicz M, Gao X, Greiwe J, Blauvelt A, Schuttelaar M, Irvine A, Levy G, Platt A, Dilley D, Teixeira H, Altman K, Grada A, Silverberg J. 533 - Long-term 5-year safety of upadacitinib in moderate-to-severe atopic dermatitis: an integrated analysis including over 7000 patient-years of exposure. British Journal Of Dermatology 2024, 190: ii35-ii36. DOI: 10.1093/bjd/ljad498.037.Peer-Reviewed Original ResearchNon-melanoma skin cancerMajor adverse cardiovascular eventsVenous thromboembolic eventsAtopic dermatitisAdverse eventsAdjudicated major adverse cardiovascular eventsOral Janus kinase 1Rate of serious infectionTreatment-emergent adverse eventsLong-term safety dataDuration of follow-upConcomitant topical corticosteroidsEfficacy of upadacitinibDouble-blind periodRate of adverse eventsPhase 3 studyDoses of upadacitinibEczematous skin lesionsExposure-adjusted ratesMATERIALS & METHODSYear of treatmentAdverse cardiovascular eventsBenefit-risk profileInflammatory skin diseaseLong-term safety504 - Investigator- and patient-rated local tolerability in phase 3 trials of topical roflumilast in patients with psoriasis, seborrheic dermatitis, and atopic dermatitis
Bunick C, Bhatia N, Del Rosso J, Draelos Z, Eichenfield L, Kircik L, Lebwohl M, Gooderham M, Green L, Hebert A, Vender R, Zirwas M, Simpson E, Gold L, Seal M, Snyder S, Osborne D, Burnett P, Higham R, Chu D, Berk D. 504 - Investigator- and patient-rated local tolerability in phase 3 trials of topical roflumilast in patients with psoriasis, seborrheic dermatitis, and atopic dermatitis. British Journal Of Dermatology 2024, 190: ii9-ii10. DOI: 10.1093/bjd/ljad498.012.Peer-Reviewed Original ResearchPhase 3 trialLocal tolerancePatient treatment adherenceAdverse eventsPenetration enhancersRoflumilast-treated patientsRate of adverse eventsTreatment adherencePatient-rated assessmentsApplication siteTopical medicationsIntertriginous areasAtopic dermatitisRoflumilast creamDay 1Seborrheic dermatitisWater-based creamRoflumilastInvestigational productPatientsInvestigator-PsoriasisPrescription productsTrialsClinicTriple-Combination Fixed-Dose Clindamycin Phosphate 1.2%/Adapalene 0.15%/Benzoyl Peroxide 3.1% for Moderate-to-Severe Acne: Efficacy and Safety Results From a Pooled Phase 3 Analysis
Stein Gold L, Gold M, Kircik L, Harper J, Del Rosso J, Bunick C, Bhatia N, Baldwin H, Draelos Z, Callender V, Lain E. Triple-Combination Fixed-Dose Clindamycin Phosphate 1.2%/Adapalene 0.15%/Benzoyl Peroxide 3.1% for Moderate-to-Severe Acne: Efficacy and Safety Results From a Pooled Phase 3 Analysis. SKIN The Journal Of Cutaneous Medicine 2024, 8: s357. DOI: 10.25251/skin.8.supp.357.Peer-Reviewed Original ResearchTreatment-emergent adverse eventsModerate-to-severe acnePhase 3 studyVehicle gelLeast-squares mean percent changesTreatment successEvaluator's Global Severity ScoreClear/almost clear skinIdentical phase 3Inflammatory/noninflammatory lesion countsTopical acne productsMild-moderate severityGlobal severity scoreReduce antibiotic resistanceNear baseline valuesPost hoc analysisCutaneous safety/tolerabilityDouble-blindModerate acneNoninflammatory lesionsClear skinLesion countsAdverse eventsAcne productsSafety resultsInvestigator- and Patient-Rated Local Tolerability in Phase 3 Trials of Topical Roflumilast in Patients With Psoriasis, Seborrheic Dermatitis, and Atopic Dermatitis
Bunick C, Bhatia N, Del Rosso J, Draelos Z, Eichenfield L, Kircik L, Lebwohl M, Gooderham M, Green L, Hebert A, Vender R, Zirwas M, Simpson E, Stein Gold L, Seal M, Snyder S, Osborne D, Burnett P, Higham R, Chu D, Berk D. Investigator- and Patient-Rated Local Tolerability in Phase 3 Trials of Topical Roflumilast in Patients With Psoriasis, Seborrheic Dermatitis, and Atopic Dermatitis. SKIN The Journal Of Cutaneous Medicine 2024, 8: s309. DOI: 10.25251/skin.8.supp.309.Peer-Reviewed Original ResearchPhase 3 trialLocal toleranceAdverse eventsPatient treatment adherencePatients discontinued due to adverse eventsAtopic dermatitisSeborrheic dermatitisPenetration enhancersRoflumilast-treated patientsRate of adverse eventsTreatment adherencePatient-rated assessmentsApplication siteTopical medicationsIntertriginous areasRoflumilast creamDay 1RoflumilastWater-based creamInvestigator-Investigational productPatientsPsoriasisDermatitisPrescription productsTriple-Combination Fixed-Dose Clindamycin Phosphate 1.2%/Adapalene 0.15%/Benzoyl Peroxide 3.1% for Moderate-to-Severe Acne: Efficacy and Safety Results From a Pooled Phase 3 Analysis
Stein Gold L, Gold M, Kircik L, Harper J, Del Rosso J, Bunick C, Bhatia N, Baldwin H, Draelos Z, Callender V, Lain E. Triple-Combination Fixed-Dose Clindamycin Phosphate 1.2%/Adapalene 0.15%/Benzoyl Peroxide 3.1% for Moderate-to-Severe Acne: Efficacy and Safety Results From a Pooled Phase 3 Analysis. SKIN The Journal Of Cutaneous Medicine 2024, 8: s339. DOI: 10.25251/skin.8.supp.339.Peer-Reviewed Original ResearchTreatment-emergent adverse eventsModerate-to-severe acnePhase 3 studyVehicle gelLeast-squares mean percent changesTreatment successEvaluator's Global Severity ScoreClear/almost clear skinIdentical phase 3Inflammatory/noninflammatory lesion countsTopical acne productsMild-moderate severityGlobal severity scoreReduce antibiotic resistanceNear baseline valuesPost hoc analysisCutaneous safety/tolerabilityDouble-blindModerate acneNoninflammatory lesionsClear skinLesion countsAdverse eventsAcne productsSafety results
2023
427 Long-term 4-year safety of upadacitinib in moderate-to-severe atopic dermatitis: results of an integrated analysis of phase 3 studies
Silverberg J, Bunick C, Lio P, Guttman-Yassky E, Boguniewicz M, Blauvelt A, Bieber T, Thyssen J, Suravaram S, Khan N, Dilley D, Teixeira H, Vigna N, Gamelli A, Grada A, Irvine A. 427 Long-term 4-year safety of upadacitinib in moderate-to-severe atopic dermatitis: results of an integrated analysis of phase 3 studies. British Journal Of Dermatology 2023, 188: ljad162.047. DOI: 10.1093/bjd/ljad162.047.Peer-Reviewed Original ResearchAbstract Atopic dermatitisNonmelanoma skin cancerMajor adverse cardiovascular eventsVenous thromboembolic eventsPhase 3 studyUpadacitinib 15Adverse eventsAtopic dermatitisSerious infectionsAdjudicated major adverse cardiovascular eventOral Janus kinase 1 inhibitorTreatment-emergent adverse eventsLong-term safety dataFavorable benefit-risk profilePivotal phase 3 studiesConcomitant topical corticosteroidsDouble-blinded periodEczematous skin lesionsEfficacy of upadacitinibPivotal phase 3Rapid itch reliefAdverse cardiovascular eventsSevere atopic dermatitisTreatment of adultsExposure-adjusted ratesPhase 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
Reduced blood-brain barrier penetration of acne vulgaris antibiotic sarecycline compared to minocycline corresponds with lower lipophilicity
Grada A, Del Rosso J, Moore A, Gold L, Harper J, Damiani G, Shaw K, Obagi S, Salem R, Tanaka S, Bunick C. Reduced blood-brain barrier penetration of acne vulgaris antibiotic sarecycline compared to minocycline corresponds with lower lipophilicity. Frontiers In Medicine 2022, 9: 1033980. PMID: 36569144, PMCID: PMC9773825, DOI: 10.3389/fmed.2022.1033980.Peer-Reviewed Original ResearchAdverse eventsClinical trialsVestibular side effectsBlood-brain barrier penetrationSecond-generation tetracyclineNon-clinical studiesLower ratesH postdosingAcne vulgarisSide effectsMinocyclineBrain samplesPotential associationSarecyclineBarrier penetrationDoxycyclineTrialsLow lipophilicityPenetranceTetracyclineDizzinessVertigoPostdosingRosaceaAcneJAK Inhibitor Safety Compared to Traditional Systemic Immunosuppressive Therapies.
Daniele S, Bunick C. JAK Inhibitor Safety Compared to Traditional Systemic Immunosuppressive Therapies. Journal Of Drugs In Dermatology 2022, 21: 1298-1303. PMID: 36468956, DOI: 10.36849/jdd.7187.Peer-Reviewed Original ResearchConceptsIncidence of adverse eventsAdverse cardiac eventsNon-melanoma skin cancerSystemic therapyAdverse eventsAtopic dermatitisCardiac eventsJAK inhibitorsVenous thromboembolismControl patientsSkin cancerIncidence rateTreatment of atopic dermatitisSystemic immunosuppressive therapyRates of non-melanoma skin cancerTraditional systemic therapiesIncidence of malignancyLong-term clinical trial dataReference control populationAtopic dermatitis treatmentBaseline rateLow incidence rateClinical trial dataImmunosuppressive therapySystemic corticosteroidsSarecycline Demonstrates Clinical Effectiveness against Staphylococcal Infections and Inflammatory Dermatoses: Evidence for Improving Antibiotic Stewardship in Dermatology
Grada A, Ghannoum MA, Bunick CG. Sarecycline Demonstrates Clinical Effectiveness against Staphylococcal Infections and Inflammatory Dermatoses: Evidence for Improving Antibiotic Stewardship in Dermatology. Antibiotics 2022, 11: 722. PMID: 35740129, PMCID: PMC9220064, DOI: 10.3390/antibiotics11060722.Peer-Reviewed Original ResearchBroad-spectrum tetracyclineInflammatory dermatosesAntibiotic stewardshipStaphylococcal infectionsClinical effectivenessSkin diseasesCutaneous staphylococcal infectionsReported adverse eventsFirst-line agentsInflammatory skin diseaseMucous membrane pemphigoidAnti-inflammatory propertiesStaphylococcal skin infectionsAntibiotic resistanceTetracycline-class antibioticsAdverse eventsAcne rosaceaClinical findingsCutaneous infectionsAcne vulgarisSkin infectionsMedicine careStrong rationaleInfectionMultiple skin diseases