The Experts below are selected from a list of 303 Experts worldwide ranked by ideXlab platform
Doron Steinberg - One of the best experts on this subject based on the ideXlab platform.
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Comparison of the efficacy of a novel sustained release clotrimazole varnish and clotrimazole Troches for the treatment of oral candidiasis
Clinical Oral Investigations, 2015Co-Authors: Rakefet Czerninski, Michael Friedman, Irith Gati, Anna Pikovsky, Doron SteinbergAbstract:Objectives Candida albicans is a common fungal infection and is commensal in 40–65 % of healthy adults. The development and pharmacokinetics of a novel sustained release clotrimazole varnish (Clot-SRV) for topical oral use have been reported. The aim of this study was to compare the efficacy of this varnish with clotrimazole Troche treatment of oral candidiasis. Materials and methods Of the 12 patients with denture stomatitis treated for 14 days, six used Clot-SRV (study group) and six clotrimazole Troches (control). The patients were instructed to use Clot-SRV (50 mg of clotrimazole) once a day, and the control group was instructed to use five Troches of 10 mg clotrimazole/day. Microbiological samples were obtained from saliva, buccal mucosa, palate, and denture. The degree of erythema was recorded at three time points, and subjective opinions noted using a questionnaire. Results At the end of the study, the control group had relatively more cases of erythema on all examined surfaces; patients who applied the Clot-SRV had significantly lower levels of candida on the denture surfaces and in saliva, and had better compliance to the medication. Conclusions The novel clotrimazole sustained release varnish may be an important part of a new protocol for oral candidiasis, with improved clinical outcomes.
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Comparison of the efficacy of a novel sustained release clotrimazole varnish and clotrimazole Troches for the treatment of oral candidiasis
Clinical Oral Investigations, 2014Co-Authors: Rakefet Czerninski, Michael Friedman, Irith Gati, Anna Pikovsky, Doron SteinbergAbstract:Objectives Candida albicans is a common fungal infection and is commensal in 40–65 % of healthy adults. The development and pharmacokinetics of a novel sustained release clotrimazole varnish (Clot-SRV) for topical oral use have been reported. The aim of this study was to compare the efficacy of this varnish with clotrimazole Troche treatment of oral candidiasis.
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A novel sustained-release clotrimazole varnish for local treatment of oral candidiasis
Clinical Oral Investigations, 2010Co-Authors: Rakefet Czerninski, Sagi Sivan, Leonid Kagan, Irith Gati, Doron Steinberg, Michael FriedmanAbstract:The use of dental varnish for therapeutic purposes has been reported for fluoride or antibacterial drugs. Our objectives were to develop a sustained-release varnish containing an antifungal drug (clotrimazole) for topical application and to evaluate the release rate of the drug in human saliva in comparison with an available commercial Troche and their acceptance by healthy volunteers. Following in vitro optimization of the release rate from the varnish, we have embarked on a crossover comparative study assessing the oral sensations and pharmacokinetics of a 10-mg clotrimazole oral Troche versus a 10-mg sustained-release clotrimazole varnish in 14 human volunteers over a period of 5 h. Saliva samples were assessed for clotrimazole concentration by high performance liquid chromatography analysis. The volunteers’ evaluation of the varnish and Troche (taste, other sensory changes, convenience, and oral suitability) were recorded. At all time points, salivary clotrimazole concentrations were higher, and the terminal half-life was significantly prolonged in the varnish group in comparison to the control group. This can be attributed to continuous release of clotrimazole from the varnish formulation. The duration of the drug over the minimal inhibitory concentration, following application of the varnish, was more than threefold longer than following administration of the Troche. The developed sustained-release varnish can be applied in patients at a lower frequency than Troches, thus, achieving higher patient compliance and efficacy. This novel varnish application can serve as the basis for a new treatment approach to oral candidiasis, a very common chronic opportunistic infection with improved clinical outcome.
Michael Friedman - One of the best experts on this subject based on the ideXlab platform.
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Comparison of the efficacy of a novel sustained release clotrimazole varnish and clotrimazole Troches for the treatment of oral candidiasis
Clinical Oral Investigations, 2015Co-Authors: Rakefet Czerninski, Michael Friedman, Irith Gati, Anna Pikovsky, Doron SteinbergAbstract:Objectives Candida albicans is a common fungal infection and is commensal in 40–65 % of healthy adults. The development and pharmacokinetics of a novel sustained release clotrimazole varnish (Clot-SRV) for topical oral use have been reported. The aim of this study was to compare the efficacy of this varnish with clotrimazole Troche treatment of oral candidiasis. Materials and methods Of the 12 patients with denture stomatitis treated for 14 days, six used Clot-SRV (study group) and six clotrimazole Troches (control). The patients were instructed to use Clot-SRV (50 mg of clotrimazole) once a day, and the control group was instructed to use five Troches of 10 mg clotrimazole/day. Microbiological samples were obtained from saliva, buccal mucosa, palate, and denture. The degree of erythema was recorded at three time points, and subjective opinions noted using a questionnaire. Results At the end of the study, the control group had relatively more cases of erythema on all examined surfaces; patients who applied the Clot-SRV had significantly lower levels of candida on the denture surfaces and in saliva, and had better compliance to the medication. Conclusions The novel clotrimazole sustained release varnish may be an important part of a new protocol for oral candidiasis, with improved clinical outcomes.
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Comparison of the efficacy of a novel sustained release clotrimazole varnish and clotrimazole Troches for the treatment of oral candidiasis
Clinical Oral Investigations, 2014Co-Authors: Rakefet Czerninski, Michael Friedman, Irith Gati, Anna Pikovsky, Doron SteinbergAbstract:Objectives Candida albicans is a common fungal infection and is commensal in 40–65 % of healthy adults. The development and pharmacokinetics of a novel sustained release clotrimazole varnish (Clot-SRV) for topical oral use have been reported. The aim of this study was to compare the efficacy of this varnish with clotrimazole Troche treatment of oral candidiasis.
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A novel sustained-release clotrimazole varnish for local treatment of oral candidiasis
Clinical Oral Investigations, 2010Co-Authors: Rakefet Czerninski, Sagi Sivan, Leonid Kagan, Irith Gati, Doron Steinberg, Michael FriedmanAbstract:The use of dental varnish for therapeutic purposes has been reported for fluoride or antibacterial drugs. Our objectives were to develop a sustained-release varnish containing an antifungal drug (clotrimazole) for topical application and to evaluate the release rate of the drug in human saliva in comparison with an available commercial Troche and their acceptance by healthy volunteers. Following in vitro optimization of the release rate from the varnish, we have embarked on a crossover comparative study assessing the oral sensations and pharmacokinetics of a 10-mg clotrimazole oral Troche versus a 10-mg sustained-release clotrimazole varnish in 14 human volunteers over a period of 5 h. Saliva samples were assessed for clotrimazole concentration by high performance liquid chromatography analysis. The volunteers’ evaluation of the varnish and Troche (taste, other sensory changes, convenience, and oral suitability) were recorded. At all time points, salivary clotrimazole concentrations were higher, and the terminal half-life was significantly prolonged in the varnish group in comparison to the control group. This can be attributed to continuous release of clotrimazole from the varnish formulation. The duration of the drug over the minimal inhibitory concentration, following application of the varnish, was more than threefold longer than following administration of the Troche. The developed sustained-release varnish can be applied in patients at a lower frequency than Troches, thus, achieving higher patient compliance and efficacy. This novel varnish application can serve as the basis for a new treatment approach to oral candidiasis, a very common chronic opportunistic infection with improved clinical outcome.
Rakefet Czerninski - One of the best experts on this subject based on the ideXlab platform.
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Comparison of the efficacy of a novel sustained release clotrimazole varnish and clotrimazole Troches for the treatment of oral candidiasis
Clinical Oral Investigations, 2015Co-Authors: Rakefet Czerninski, Michael Friedman, Irith Gati, Anna Pikovsky, Doron SteinbergAbstract:Objectives Candida albicans is a common fungal infection and is commensal in 40–65 % of healthy adults. The development and pharmacokinetics of a novel sustained release clotrimazole varnish (Clot-SRV) for topical oral use have been reported. The aim of this study was to compare the efficacy of this varnish with clotrimazole Troche treatment of oral candidiasis. Materials and methods Of the 12 patients with denture stomatitis treated for 14 days, six used Clot-SRV (study group) and six clotrimazole Troches (control). The patients were instructed to use Clot-SRV (50 mg of clotrimazole) once a day, and the control group was instructed to use five Troches of 10 mg clotrimazole/day. Microbiological samples were obtained from saliva, buccal mucosa, palate, and denture. The degree of erythema was recorded at three time points, and subjective opinions noted using a questionnaire. Results At the end of the study, the control group had relatively more cases of erythema on all examined surfaces; patients who applied the Clot-SRV had significantly lower levels of candida on the denture surfaces and in saliva, and had better compliance to the medication. Conclusions The novel clotrimazole sustained release varnish may be an important part of a new protocol for oral candidiasis, with improved clinical outcomes.
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Comparison of the efficacy of a novel sustained release clotrimazole varnish and clotrimazole Troches for the treatment of oral candidiasis
Clinical Oral Investigations, 2014Co-Authors: Rakefet Czerninski, Michael Friedman, Irith Gati, Anna Pikovsky, Doron SteinbergAbstract:Objectives Candida albicans is a common fungal infection and is commensal in 40–65 % of healthy adults. The development and pharmacokinetics of a novel sustained release clotrimazole varnish (Clot-SRV) for topical oral use have been reported. The aim of this study was to compare the efficacy of this varnish with clotrimazole Troche treatment of oral candidiasis.
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A novel sustained-release clotrimazole varnish for local treatment of oral candidiasis
Clinical Oral Investigations, 2010Co-Authors: Rakefet Czerninski, Sagi Sivan, Leonid Kagan, Irith Gati, Doron Steinberg, Michael FriedmanAbstract:The use of dental varnish for therapeutic purposes has been reported for fluoride or antibacterial drugs. Our objectives were to develop a sustained-release varnish containing an antifungal drug (clotrimazole) for topical application and to evaluate the release rate of the drug in human saliva in comparison with an available commercial Troche and their acceptance by healthy volunteers. Following in vitro optimization of the release rate from the varnish, we have embarked on a crossover comparative study assessing the oral sensations and pharmacokinetics of a 10-mg clotrimazole oral Troche versus a 10-mg sustained-release clotrimazole varnish in 14 human volunteers over a period of 5 h. Saliva samples were assessed for clotrimazole concentration by high performance liquid chromatography analysis. The volunteers’ evaluation of the varnish and Troche (taste, other sensory changes, convenience, and oral suitability) were recorded. At all time points, salivary clotrimazole concentrations were higher, and the terminal half-life was significantly prolonged in the varnish group in comparison to the control group. This can be attributed to continuous release of clotrimazole from the varnish formulation. The duration of the drug over the minimal inhibitory concentration, following application of the varnish, was more than threefold longer than following administration of the Troche. The developed sustained-release varnish can be applied in patients at a lower frequency than Troches, thus, achieving higher patient compliance and efficacy. This novel varnish application can serve as the basis for a new treatment approach to oral candidiasis, a very common chronic opportunistic infection with improved clinical outcome.
Irith Gati - One of the best experts on this subject based on the ideXlab platform.
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Comparison of the efficacy of a novel sustained release clotrimazole varnish and clotrimazole Troches for the treatment of oral candidiasis
Clinical Oral Investigations, 2015Co-Authors: Rakefet Czerninski, Michael Friedman, Irith Gati, Anna Pikovsky, Doron SteinbergAbstract:Objectives Candida albicans is a common fungal infection and is commensal in 40–65 % of healthy adults. The development and pharmacokinetics of a novel sustained release clotrimazole varnish (Clot-SRV) for topical oral use have been reported. The aim of this study was to compare the efficacy of this varnish with clotrimazole Troche treatment of oral candidiasis. Materials and methods Of the 12 patients with denture stomatitis treated for 14 days, six used Clot-SRV (study group) and six clotrimazole Troches (control). The patients were instructed to use Clot-SRV (50 mg of clotrimazole) once a day, and the control group was instructed to use five Troches of 10 mg clotrimazole/day. Microbiological samples were obtained from saliva, buccal mucosa, palate, and denture. The degree of erythema was recorded at three time points, and subjective opinions noted using a questionnaire. Results At the end of the study, the control group had relatively more cases of erythema on all examined surfaces; patients who applied the Clot-SRV had significantly lower levels of candida on the denture surfaces and in saliva, and had better compliance to the medication. Conclusions The novel clotrimazole sustained release varnish may be an important part of a new protocol for oral candidiasis, with improved clinical outcomes.
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Comparison of the efficacy of a novel sustained release clotrimazole varnish and clotrimazole Troches for the treatment of oral candidiasis
Clinical Oral Investigations, 2014Co-Authors: Rakefet Czerninski, Michael Friedman, Irith Gati, Anna Pikovsky, Doron SteinbergAbstract:Objectives Candida albicans is a common fungal infection and is commensal in 40–65 % of healthy adults. The development and pharmacokinetics of a novel sustained release clotrimazole varnish (Clot-SRV) for topical oral use have been reported. The aim of this study was to compare the efficacy of this varnish with clotrimazole Troche treatment of oral candidiasis.
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A novel sustained-release clotrimazole varnish for local treatment of oral candidiasis
Clinical Oral Investigations, 2010Co-Authors: Rakefet Czerninski, Sagi Sivan, Leonid Kagan, Irith Gati, Doron Steinberg, Michael FriedmanAbstract:The use of dental varnish for therapeutic purposes has been reported for fluoride or antibacterial drugs. Our objectives were to develop a sustained-release varnish containing an antifungal drug (clotrimazole) for topical application and to evaluate the release rate of the drug in human saliva in comparison with an available commercial Troche and their acceptance by healthy volunteers. Following in vitro optimization of the release rate from the varnish, we have embarked on a crossover comparative study assessing the oral sensations and pharmacokinetics of a 10-mg clotrimazole oral Troche versus a 10-mg sustained-release clotrimazole varnish in 14 human volunteers over a period of 5 h. Saliva samples were assessed for clotrimazole concentration by high performance liquid chromatography analysis. The volunteers’ evaluation of the varnish and Troche (taste, other sensory changes, convenience, and oral suitability) were recorded. At all time points, salivary clotrimazole concentrations were higher, and the terminal half-life was significantly prolonged in the varnish group in comparison to the control group. This can be attributed to continuous release of clotrimazole from the varnish formulation. The duration of the drug over the minimal inhibitory concentration, following application of the varnish, was more than threefold longer than following administration of the Troche. The developed sustained-release varnish can be applied in patients at a lower frequency than Troches, thus, achieving higher patient compliance and efficacy. This novel varnish application can serve as the basis for a new treatment approach to oral candidiasis, a very common chronic opportunistic infection with improved clinical outcome.
Robert W Holloway - One of the best experts on this subject based on the ideXlab platform.
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patient centred outcomes in the phase 3 study ariel3 of rucaparib maintenance treatment in patients with platinum sensitive recurrent ovarian carcinoma post hoc exploratory analyses by brca mutation status and patient age
International Journal of Gynecologic Cancer, 2019Co-Authors: N Colombo, D Lorusso, Carol Aghajanian, Ana Oaknin, A Dean, J I Weberpals, Andrew R Clamp, Giovanni Scambia, Alexandra Leary, Robert W HollowayAbstract:Introduction/Background Maintenance therapy for recurrent ovarian cancer is intended to extend progression-free survival (PFS) without compromising patient quality of life; therefore, the clinical benefits of prolonged PFS should be evaluated in the context of toxicities that may compromise patients‘ wellbeing. In ARIEL3 (CO-338-014; NCT01968213), rucaparib significantly improved PFS vs placebo in all predefined patient cohorts regardless of biomarker status (Coleman et al. Lancet. 2017;390:1949-61) or age (Ledermann et al. Presented at SGO 2019; abst 4). This post hoc exploratory analysis examined quality-adjusted PFS (QA-PFS) and quality-adjusted time without symptoms or toxicity (Q-TWiST) in patients from ARIEL3, including the subgroup of patients with a BRCA mutation and subgroups based on patient age. Methodology Patients were randomised 2:1 to oral rucaparib (600 mg BID) or placebo. QA-PFS and Q-TWiST were analysed in patients with a BRCA mutation (germline, somatic, or origin unknown), the ITT population (ie, all randomised patients), and subgroups of the ITT population defined by patient age at baseline ( Results The visit cutoff date for these analyses was 15 April 2017. QA-PFS, Q-TWiST considering grade ≥3 TEAEs, and Q-TWiST considering select grade ≥2 TEAEs were significantly longer with rucaparib than placebo in patients with a BRCA mutation and in the ITT population (table). Across all age subgroups, QA-PFS and Q-TWiST (both analyses) were significantly longer with rucaparib than placebo (table 1). Conclusion In the ITT population, BRCA-mutant subgroup, and age subgroups analysed, the quality-adjusted analyses, which incorporated patient-centred perspectives, confirmed the benefit of rucaparib vs placebo. Disclosure NC: Clovis, Advaxis, AstraZeneca, BIOCAD, MSD, Pfizer, PharmaMar, Roche, Takeda, Tesaro AMO: Clovis, Amgen, Immunovaccine, Verastem, AstraZeneca, WebRx DL: Clovis, AstraZeneca, ImmunoGen, Merck, PharmaMar, Roche, Takeda, Tesaro CA: Clovis, Mateon, Bayer, Cerulean, Tesaro, VentiRx AO: Clovis, AstraZeneca, ImmunoGen, Genmab/Seattle Genetics, PharmaMar, Roche, Tesaro AD: Precision Oncology Australia, Shire, Specialised Therapeutics Australia JIW: AbbVie, AstraZeneca ARC: AstraZeneca, Roche, Clovis GS: Clovis, AstraZeneca, PharmaMar, Roche, Tesaro AL: Clovis, Pfizer, PharmaMar, GamaMabs, Merus, AstraZeneca RWH: Clovis, AstraZeneca, Tesaro MAG: Clovis, AstraZeneca, PharmaMar, Roche PCF: Clovis, AstraZeneca JCG: AstraZeneca, BMS, Janssen, Ipsen, MSD, Astellas DMO’M: Clovis, AstraZeneca, Gynecologic Oncology Group, Janssen, Myriad, Tesaro, Amgen, ImmunoGen, AbbVie, Ambry, Health Analytics, Agenus, Ajinomoto, Array, BMS, ERGOMED Clinical Research, Exelixis, Genentech, GSK, INC Research, inVentiv Health Clinical, Ludwig Institute for Cancer Research, Novartis, PRA International, Regeneron, Serono, Stemcentrx, TRACON DKA: Morphotek, Clovis, Advaxis, AstraZeneca, Pfizer, Syndax, Tesaro SB: Clovis, AstraZeneca, ImmunoGen, GamaMabs, Merck Serono, PharmaMar, Roche, Seattle Genetics, Tesaro JG-D: AstraZeneca, Clovis, Genentech/Roche, Janssen EMS: nothing to disclose JM: Modus Outcomes TC, LM, SG, JB: Clovis RLC: Clovis, AbbVie, AstraZeneca, Esperance, Janssen, Merck, Millennium, OncoMed, Roche/Genentech, Bayer, GamaMabs, Genmab, Gradalis, Millennium, Pfizer, Tesaro JAL: Clovis, AstraZeneca, Pfizer, Artios Pharma, Cristal Therapeutics, Merck/MSD, Regeneron, Roche, Seattle Genetics, Tesaro.
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effect of progression free interval pfi following penultimate platinum based regimen on the efficacy of rucaparib maintenance treatment in patients with platinum sensitive recurrent ovarian carcinoma an analysis from the phase 3 study ariel3
International Journal of Gynecologic Cancer, 2019Co-Authors: Andrew R Clamp, N Colombo, D Lorusso, Carol Aghajanian, Ana Oaknin, A Dean, J I Weberpals, Giovanni Scambia, Alexandra Leary, Robert W HollowayAbstract:Introduction/Background In ARIEL3, rucaparib maintenance treatment significantly improved progression-free survival (PFS) vs placebo in all patient populations, regardless of biomarker status (Coleman et al. Lancet. 2017;390:1949–61). This subgroup analysis examined the effect of the stratification factor PFI following penultimate platinum-based chemotherapy (also a prognostic factor in ovarian cancer) on primary and secondary endpoints of investigator-assessed and blinded independent central review (BICR)-assessed PFS in ARIEL3. Methodology Patients were randomised 2:1 to oral rucaparib (600 mg BID) or placebo. Analysis was based on the randomisation stratification factor of PFI following penultimate platinum-based regimen: 6–12 months or >12 months. PFS was assessed in 3 predefined cohorts: BRCA mutant; BRCA mutant + BRCA wild type/high loss of heterozygosity (LOH high); and intent-to-treat (ITT) population. Safety was assessed in all patients who received ≥1 dose of rucaparib. Results Visit cutoff dates for efficacy and safety were 15 April 2017 and 31 December 2017, respectively. For all predefined cohorts, investigator and BICR assessments showed a significant PFS improvement with rucaparib vs placebo in both PFI subgroups (figure 1). As expected, patients receiving placebo with a PFI 6–12 months had a shorter median PFS than those with a PFI >12 months. The treatment by PFI subgroup interaction was not significant, indicating that the treatment benefit was similar in both PFI subgroups. Safety data in the PFI subgroups were consistent with the overall study population, as previously reported. Conclusion In ARIEL3, rucaparib maintenance treatment significantly improved PFS vs placebo in all cohorts, irrespective of PFI subgroup. The magnitude of treatment effect was similar for both PFI subgroups. Disclosure ARC: AstraZeneca, Roche, Clovis AMO: Clovis, Amgen, Immunovaccine, Verastem, AstraZeneca, WebRx DL: Clovis, AstraZeneca, ImmunoGen, Merck, PharmaMar, Roche, Takeda, Tesaro CA: Clovis, Mateon, Bayer, Cerulean, Tesaro, VentiRx AO: Clovis, AstraZeneca, ImmunoGen, Genmab/Seattle Genetics, PharmaMar, Roche, Tesaro AD: Precision Oncology Australia, Shire Pharmaceuticals, Specialised Therapeutics Australia NC: Clovis, Advaxis, AstraZeneca, BIOCAD, MSD, Pfizer, PharmaMar, Roche, Takeda, Tesaro JIW: AbbVie, AstraZeneca GS: Clovis, AstraZeneca, PharmaMar, Roche, Tesaro AL: Clovis, Pfizer, PharmaMar, GamaMabs, Merus, AstraZeneca RWH: Clovis, AstraZeneca, Tesaro MAG: Clovis, AstraZeneca, PharmaMar, Roche PCF: Clovis, AstraZeneca JCG: AstraZeneca, BMS, Janssen, Ipsen, MSD, Astellas DMO’M: Clovis, AstraZeneca, Gynecologic Oncology Group, Janssen, Myriad, Tesaro, Amgen, ImmunoGen, AbbVie, Ambry, Health Analytics, Agenus, Ajinomoto, Array BioPharma, BMS, ERGOMED Clinical Research, Exelixis, Genentech, GSK, INC Research, inVentiv Health Clinical, Ludwig Institute for Cancer Research, Novartis, PRA International, Regeneron, Serono, Stemcentrx, TRACON DKA: Morphotek, Clovis, Advaxis, AstraZeneca, Pfizer, Syndax, Tesaro SB: Clovis, AstraZeneca, ImmunoGen, GamaMabs, Merck Serono, PharmaMar, Roche, Seattle Genetics, Tesaro JG-D: AstraZeneca, Clovis, Genentech/Roche, Janssen EMS: nothing to disclose TC, LM, SG: Clovis RLC: Clovis, AbbVie, AstraZeneca, Esperance, Janssen, Merck, Millennium, OncoMed, Roche/Genentech, Bayer, GamaMabs, Genmab, Gradalis, Pfizer, Tesaro JAL: Clovis, AstraZeneca, Pfizer, Artios Pharma, Cristal Therapeutics, MSD, Regeneron, Roche, Seattle Genetics, Tesaro.
