The Experts below are selected from a list of 243 Experts worldwide ranked by ideXlab platform

Steven R. Feldman - One of the best experts on this subject based on the ideXlab platform.

  • Comparing prescribing patterns for topical corticosteroids based on their FDA indication by age.
    Pediatric dermatology, 2020
    Co-Authors: Megan E Freeze, Steven R. Feldman, Abigail Cline, Esther A Balogh, Alan B Fleischer
    Abstract:

    Atopic dermatitis (AD) affects up to 20% of the pediatric population, with a growing prevalence over the past 30 years. Topical corticosteroids (TCS) are commonly used as a first-line topical therapy for AD and are prescribed in 59% of all AD visits. However, some topical corticosteroids are prescribed outside of their age range indications. This paper aims to explore the frequency with which topical corticosteroids are prescribed for AD outside of their FDA-approved age range. Data on prescribing patterns for AD were obtained from the National Ambulatory Medical Care Survey (NAMCS). We assessed the frequency of off-label use of topical corticosteroids with respect to age indications in four specific age-groups, as delineated in the data (0-1, 2-7, 8-18, and 19+ years). All prescribed topical corticosteroids found in the NAMCS database have an indication for AD or other inflammatory dermatoses or pruritic dermatoses. However, some medications were prescribed outside of their FDA-approved age indications. These off-label prescription rates ranged from 52% for Desoximetasone to 0% for halobetasol and alclometasone, or rates lower than could be detected by our study. Much like other medications for AD treatment, TCS are sometimes used off-label. The off-label use of topical corticosteroids to treat pediatric AD highlights a gap between clinical practice and regulating guidelines. Additional pediatric studies would offer a greater body of evidence to maintain or expand label indications for the use of TCS in younger patients. © 2020 Wiley Periodicals LLC.

  • Adherence to topical treatment can improve treatment-resistant moderate psoriasis.
    Cutis, 2020
    Co-Authors: Nwanneka Okwundu, Leah A. Cardwell, Abigail Cline, Irma Richardson, Steven R. Feldman
    Abstract:

    Most patients with psoriasis have limited disease that should be manageable with topical treatment. However, psoriasis often is resistant to topical treatment. The aim of our study was to determine if patients using psoriasis-resistant topical treatments can be effectively treated with topicals under conditions promoting adherence. During this open-label, randomized, single-center clinical study, 12 patients with moderate psoriasis that previously failed topical treatment were selected and treated with Desoximetasone spray 0.25% for 2 weeks. Six patients were randomized to receive twice-daily telephone call reminders to further encourage good adherence. Disease severity was assessed by the visual analog scale for pruritus, psoriasis area and severity index (PASI), total lesion severity score (TLSS), and investigator global assessment (IGA). At the end of the study, most patients improved in most scores. Therefore, apparent resistance to topical treatment often is due to poor adherence and can be overcome, at least over the short term.

  • Patients preferences for different corticosteroid vehicles are highly variable
    Journal of Dermatological Treatment, 2019
    Co-Authors: Kayla Felix, Elias Oussedik, Leah A. Cardwell, Irma Richardson, Emily L Unrue, Meyene Inyang, Steven R. Feldman
    Abstract:

    Introduction: Topical corticosteroids, available in an array of vehicles are used to control a variety of inflammatory skin diseases. Patients preferences for different vehicles may affect their willingness to use treatment. We assess corticosteroid vehicle preference and potential impact of topical characteristics on adherence and quality of life in patients with psoriasis.Methods: Subjects with psoriasis were recruited from Wake Forest University Dermatology Clinic. Subjects sampled Desoximetasone 0.25% spray, betamethasone valerate 0.1% cream, triamcinolone acetonide 0.1% ointment, fluocinonide 0.05% gel, betamethasone valerate 0.1% lotion, clobetasol propionate 0.05% foam, and fluocinonide 0.05% solution in a predetermined randomized order. Subjects completed a Vehicle Preference Measure, Determinants of Adherence Measure, and a Determinants of Quality of Life Measure.Results: Patients preferences for the various products were highly variable. Regarding Determinants of Adherence, patients perception of absorption of the medication was ranked as 'quite important/extremely important' by 85% of total subjects. A majority of patients rated medication side effects as 'quite important/extremely important' when asked to consider topical characteristics effect on quality of life.Discussion: There was wide variation in patient preference for topical medication vehicles used for treating psoriasis. Several vehicle characteristics were considered important to adherence. Given the marked variation in vehicle preference, topical treatment should be individualized according to patients preferences.

  • A review of topical corticosteroid sprays for the treatment of inflammatory dermatoses.
    Dermatology online journal, 2019
    Co-Authors: Kyle A Habet, Sree S Kolli, Adrian Pona, Steven R. Feldman
    Abstract:

    Background: Topical corticosteroids are available in many vehicles. However, patients' preference for vehicles are variable and could be tailored to maximize patient adherence. Spray vehicles may offer, convenience, and strong efficacy. Methods: A literature review was conducted using keywords: clobetasol, Desoximetasone, betamethasone, triamcinolone, corticosteroid, topical, spray, vehicles, treatment, and clinical trial. Results: For moderate-to-severe plaque psoriasis, 87% of subjects achieved an Overall Disease Severity (ODS) Score ≤2 at week two and 78% achieved an ODS ≤1 after four weeks with clobetasol propionate (CP) 0.05% spray compared to 17% and 3% in the control group, respectively (P

  • Is topical treatment effective for psoriasis in patients who failed topical treatment
    The Journal of dermatological treatment, 2019
    Co-Authors: Nwanneka Okwundu, Leah A. Cardwell, Abigail Cline, Irma Richardson, Steven R. Feldman
    Abstract:

    AbstractObjectives: To determine if resistance to topical treatments can be overcome under conditions promoting adherence.Materials and Methods: Twelve psoriasis patients treated with topical 0.25% Desoximetasone spray were randomized to either twice daily phone call reminders or no phone call and were treated for 2 weeks. Pruritus Visual Analog Scale (VAS), Psoriasis Area and Severity Index (PASI), Total Lesion Severity Score (TLSS), and, Investigator Global Assessment (IGA) assessed disease severity.Results: Most subjects improved in most scoring parameters. 100%, 91.7%, 83.3%, and 58.3% had improvements in itching, PASI, TLSS, and IGA, respectively.Conclusions: While our sample size was small and treatment duration short, the effect size of topical treatment was large under conditions designed to promote adherence.

Hans Christian Korting - One of the best experts on this subject based on the ideXlab platform.

  • Activity of Different Desoximetasone Preparations Compared to Other Topical Corticosteroids in the Vasoconstriction Assay
    Skin pharmacology and physiology, 2008
    Co-Authors: Claudia Borelli, J. Gassmueller, Joachim W. Fluhr, K. H. Nietsch, S. Schinzel, Hans Christian Korting
    Abstract:

    Introduction: We report on a double-blind, vehicle-controlled, single-center confirmatory study with random assignment. The purpose of the study was to investigate the topical bioav

  • Cutaneous Inflammation and Proliferation in vitro: Differential Effects and Mode of Action of Topical Glucocorticoids
    Skin pharmacology and applied skin physiology, 2000
    Co-Authors: Katharina Lange, Anja Gysler, Michael Bader, Burkhard Kleuser, Hans Christian Korting, Claudia Maia, Claus Scheidereit, Monika Schäfer-korting
    Abstract:

    The nonhalogenated double ester of prednisolone, prednicarbate (PC), is the first topical glucocorticoid with an improved benefit/risk ratio verified clinically and in vitro. To evaluate if this is due to unique characteristics of this steroid, a new compound created according to an identical concept, prednisolone 17-ethylcarbonate, 21-phenylacetate (PEP), and the new halogenated monoester Desoximetasone 21-cinnamate (DCE) were tested and compared to PC, Desoximetasone (DM) and betamethasone 17-valerate (BMV). Isolated foreskin keratinocytes served for in vitro investigations of anti-inflammatory processes in the epidermis, fibroblasts of the same origin were used to investigate the atrophogenic potential. Inflammation was induced by TNFα, resulting in an increased interleukin 1α (Il-1α) synthesis. As quantified by ELISA, all drugs significantly reduced Il-1α production. But PC and BMV appeared particularly potent, followed by DM and the two new congeners, which revealed minor anti-inflammatory activity. Glucocorticoid esters including PEP are rapidly degraded in keratinocytes (85% within 12 h). Hence, a ribonuclease protection assay of Il-1α mRNA was performed allowing short incubation times and thus minimizing biodegradation. This assay confirmed the anti-inflammatory potency of native PC and BMV. In contrary DCE and PEP did not reduce Il-1α mRNA to a significant extent. Therefore PEP acts as a prodrug only. In fibroblasts, Il-1α and Il-6 syntheses indicate proliferation and inflammation, respectively. Whereas PC and PEP inhibited Il-1α and Il-6 production in fibroblasts only to a minor extent, cytokine synthesis was strongly affected by the conventional glucocorticoids BMV and DM, but also by DCE. The minor unwanted effect of PC and PEP on fibroblasts was also reflected by their low influence on cell proliferation as derived from 3H-thymidine incorporation. Again, more pronounced antiproliferative features were seen with the halogenated glucocorticoids. In the following, the correlation between antiphlogistic effects in keratinocytes (suppression of Il-1α) and antiproliferative effects in fibroblasts (suppression of Il-1α and Il-6; 3H-thymidine incorporation) was analyzed. Here, PC is revealed as the only glucocorticoid with an improved benefit/risk ratio. Native PEP is shown to be almost ineffective and DCE presents exactly the opposite features of PC. It is tempting to speculate if this is due to different glucocorticoid receptor subtypes or different signaling pathways in keratinocytes and fibroblasts.

  • Prednicarbate Versus Conventional Topical Glucocorticoids: Pharmacodynamic Characterization In Vitro
    Pharmaceutical Research, 1997
    Co-Authors: Katharina Lange, Anja Gysler, Michael Bader, Burkhard Kleuser, Hans Christian Korting, Monika Schäfer-korting
    Abstract:

    Purpose . Pharmacodynamic characterization of topical glucocorticoids as prednicarbate (PC), its metabolites prednisolone 17-ethylcarbonate (PEC) and prednisolone (PD), betamethasone 17-valerate (BMV), beta-methasone (BM) and Desoximetasone (DM) by evaluating their effects on epidermal and dermal cells. Synopsis of pharmacokinetic and pharmacodynamic studies, possibly explaining the improved benefit-risk ratio of prednicarbate. Methods . Isolated foreskin keratinocytes were used to investigate the influence on epidermal inflammatory processes, dermal fibroblasts of the same origin to study antiproliferative activities of glucocorticoids. Interleukins were measured by ELISA-assay, the influence on II-lα-production also on mRNA-level by RNAse protection assay. Proliferation was assessed by ^3H thymidine incorporation and biodegradation by HPLC/UV-absorption. Cell viability was controlled by MTT assay. Results . In keratinocytes, inflammation was induced by TNFα, resulting in an increased II- lα synthesis. This cytokine was particularly suppressed by PC and BMV, whereas PEC, PD, DM and BM were less potent (p ≤ 0.05). Since, however, the double ester PC is rapidly degraded in keratinocytes, a RNAse-protection assay of II-1α mRNA was performed allowing short incubation times and thus minimizing biodegradation effects. In agreement with the previous experiment, the antiinflammatory potency of native PC was confirmed. In fibroblasts, II-lα and II-6 synthesis indicate proliferation and inflammation respectively. Whereas PC inhibited II- lα and II-6 production in fibroblasts to a minor extent only, it was strongly reduced by the conventional glucocorticoids and PEC (p ≤ 0.05). The minor unwanted effect of PC on fibroblasts was also reflected by its low influence on cell proliferation as assayed by ^3H thymindine incorporation. More pronounced antiproliferative features were observed with BM, PEC and espectially BMV. Conclusions . Correlating antiphlogistic effects in keratinocytes (suppression of II-lα) with antiproliferative effects in fibroblasts (suppression of II-lα and II-6), the improved benefit−risk ratio of PC compared to conventional glucocorticoids does not result only from distinct drug metabolism in the skin but also from a specific influence on the cytokine network.

  • Prednicarbate Versus Conventional Topical Glucocorticoids: Pharmacodynamic Characterization In Vitro
    Pharmaceutical research, 1997
    Co-Authors: Katharina Lange, Anja Gysler, Michael Bader, Burkhard Kleuser, Hans Christian Korting, Monika Schäfer-korting
    Abstract:

    Purpose. Pharmacodynamic characterization of topical glucocorticoids as prednicarbate (PC), its metabolites prednisolone 17-ethylcarbonate (PEC) and prednisolone (PD), betamethasone 17-valerate (BMV), beta-methasone (BM) and Desoximetasone (DM) by evaluating their effects on epidermal and dermal cells. Synopsis of pharmacokinetic and pharmacodynamic studies, possibly explaining the improved benefit-risk ratio of prednicarbate.

Monika Schäfer-korting - One of the best experts on this subject based on the ideXlab platform.

  • Cutaneous Inflammation and Proliferation in vitro: Differential Effects and Mode of Action of Topical Glucocorticoids
    Skin pharmacology and applied skin physiology, 2000
    Co-Authors: Katharina Lange, Anja Gysler, Michael Bader, Burkhard Kleuser, Hans Christian Korting, Claudia Maia, Claus Scheidereit, Monika Schäfer-korting
    Abstract:

    The nonhalogenated double ester of prednisolone, prednicarbate (PC), is the first topical glucocorticoid with an improved benefit/risk ratio verified clinically and in vitro. To evaluate if this is due to unique characteristics of this steroid, a new compound created according to an identical concept, prednisolone 17-ethylcarbonate, 21-phenylacetate (PEP), and the new halogenated monoester Desoximetasone 21-cinnamate (DCE) were tested and compared to PC, Desoximetasone (DM) and betamethasone 17-valerate (BMV). Isolated foreskin keratinocytes served for in vitro investigations of anti-inflammatory processes in the epidermis, fibroblasts of the same origin were used to investigate the atrophogenic potential. Inflammation was induced by TNFα, resulting in an increased interleukin 1α (Il-1α) synthesis. As quantified by ELISA, all drugs significantly reduced Il-1α production. But PC and BMV appeared particularly potent, followed by DM and the two new congeners, which revealed minor anti-inflammatory activity. Glucocorticoid esters including PEP are rapidly degraded in keratinocytes (85% within 12 h). Hence, a ribonuclease protection assay of Il-1α mRNA was performed allowing short incubation times and thus minimizing biodegradation. This assay confirmed the anti-inflammatory potency of native PC and BMV. In contrary DCE and PEP did not reduce Il-1α mRNA to a significant extent. Therefore PEP acts as a prodrug only. In fibroblasts, Il-1α and Il-6 syntheses indicate proliferation and inflammation, respectively. Whereas PC and PEP inhibited Il-1α and Il-6 production in fibroblasts only to a minor extent, cytokine synthesis was strongly affected by the conventional glucocorticoids BMV and DM, but also by DCE. The minor unwanted effect of PC and PEP on fibroblasts was also reflected by their low influence on cell proliferation as derived from 3H-thymidine incorporation. Again, more pronounced antiproliferative features were seen with the halogenated glucocorticoids. In the following, the correlation between antiphlogistic effects in keratinocytes (suppression of Il-1α) and antiproliferative effects in fibroblasts (suppression of Il-1α and Il-6; 3H-thymidine incorporation) was analyzed. Here, PC is revealed as the only glucocorticoid with an improved benefit/risk ratio. Native PEP is shown to be almost ineffective and DCE presents exactly the opposite features of PC. It is tempting to speculate if this is due to different glucocorticoid receptor subtypes or different signaling pathways in keratinocytes and fibroblasts.

  • Prednicarbate Versus Conventional Topical Glucocorticoids: Pharmacodynamic Characterization In Vitro
    Pharmaceutical Research, 1997
    Co-Authors: Katharina Lange, Anja Gysler, Michael Bader, Burkhard Kleuser, Hans Christian Korting, Monika Schäfer-korting
    Abstract:

    Purpose . Pharmacodynamic characterization of topical glucocorticoids as prednicarbate (PC), its metabolites prednisolone 17-ethylcarbonate (PEC) and prednisolone (PD), betamethasone 17-valerate (BMV), beta-methasone (BM) and Desoximetasone (DM) by evaluating their effects on epidermal and dermal cells. Synopsis of pharmacokinetic and pharmacodynamic studies, possibly explaining the improved benefit-risk ratio of prednicarbate. Methods . Isolated foreskin keratinocytes were used to investigate the influence on epidermal inflammatory processes, dermal fibroblasts of the same origin to study antiproliferative activities of glucocorticoids. Interleukins were measured by ELISA-assay, the influence on II-lα-production also on mRNA-level by RNAse protection assay. Proliferation was assessed by ^3H thymidine incorporation and biodegradation by HPLC/UV-absorption. Cell viability was controlled by MTT assay. Results . In keratinocytes, inflammation was induced by TNFα, resulting in an increased II- lα synthesis. This cytokine was particularly suppressed by PC and BMV, whereas PEC, PD, DM and BM were less potent (p ≤ 0.05). Since, however, the double ester PC is rapidly degraded in keratinocytes, a RNAse-protection assay of II-1α mRNA was performed allowing short incubation times and thus minimizing biodegradation effects. In agreement with the previous experiment, the antiinflammatory potency of native PC was confirmed. In fibroblasts, II-lα and II-6 synthesis indicate proliferation and inflammation respectively. Whereas PC inhibited II- lα and II-6 production in fibroblasts to a minor extent only, it was strongly reduced by the conventional glucocorticoids and PEC (p ≤ 0.05). The minor unwanted effect of PC on fibroblasts was also reflected by its low influence on cell proliferation as assayed by ^3H thymindine incorporation. More pronounced antiproliferative features were observed with BM, PEC and espectially BMV. Conclusions . Correlating antiphlogistic effects in keratinocytes (suppression of II-lα) with antiproliferative effects in fibroblasts (suppression of II-lα and II-6), the improved benefit−risk ratio of PC compared to conventional glucocorticoids does not result only from distinct drug metabolism in the skin but also from a specific influence on the cytokine network.

  • Prednicarbate Versus Conventional Topical Glucocorticoids: Pharmacodynamic Characterization In Vitro
    Pharmaceutical research, 1997
    Co-Authors: Katharina Lange, Anja Gysler, Michael Bader, Burkhard Kleuser, Hans Christian Korting, Monika Schäfer-korting
    Abstract:

    Purpose. Pharmacodynamic characterization of topical glucocorticoids as prednicarbate (PC), its metabolites prednisolone 17-ethylcarbonate (PEC) and prednisolone (PD), betamethasone 17-valerate (BMV), beta-methasone (BM) and Desoximetasone (DM) by evaluating their effects on epidermal and dermal cells. Synopsis of pharmacokinetic and pharmacodynamic studies, possibly explaining the improved benefit-risk ratio of prednicarbate.

Mohammed D. Saleem - One of the best experts on this subject based on the ideXlab platform.

  • Desoximetasone 0 25 spray adrenal suppression and efficacy in extensive plaque psoriasis
    Journal of Dermatological Treatment, 2018
    Co-Authors: Mohammed D. Saleem, Steven R. Feldman
    Abstract:

    In extensive psoriasis, topical corticosteroids are generally only used to supplement phototherapy and systemic therapy. Spray formulations are easier than other vehicle preparations to apply and may be an option for treating extensive psoriasis.To evaluate the potential for hypothalamic-pituitary-adrenal axis suppression and efficacy of topical Desoximetasone 0.25% spray formulation in patients with extensive psoriasis.A multicenter, open label, nonrandomized, clinical trial was conducted. Two groups of 12 adults with moderate to severe plaque-type psoriasis were treated with 0.25% Desoximetasone spray for 28 days. Physician global assessment (PGA) and body surface area (BSA) were assessed. Cortisol-induced suppression test was performed at baseline, day 14 and day 28 to assess safety.No statistically significant difference was seen in adrenal suppression; odds ratio of 0.779 (p = .85). The mean PGA improvement from baseline was 1.83 and 1.33 for moderate and severe psoriasis, respectively. Mean BSA involvement at baseline for moderate and severe psoriasis was 11% and 23%, respectively, improving to 5% and 19%, respectively.Considerable improvement can be achieved with short-term potent topical corticosteroid treatment even in patients with severe, extensive psoriasis. For such use, topical Desoximetasone has less risk of HPA-suppression than does topical clobetasol.

  • Desoximetasone 0 25 spray adrenal suppression and efficacy in extensive plaque psoriasis
    Journal of Dermatological Treatment, 2018
    Co-Authors: Mohammed D. Saleem, Steven R. Feldman
    Abstract:

    Background: In extensive psoriasis, topical corticosteroids are generally only used to supplement phototherapy and systemic therapy. Spray formulations are easier than other vehicle preparations to...

  • topical 0 25 Desoximetasone spray efficacy for moderate to severe plaque psoriasis a randomized clinical trial
    Journal of Dermatological Treatment, 2018
    Co-Authors: Mohammed D. Saleem, Deborah Negus, Steven R. Feldman
    Abstract:

    Background: Traditionally, ointments were the vehicle of choice for psoriasis. Poor adherence of traditional vehicles limits the use of topical corticosteroids. Alternative formulations have gained...

  • A Randomized, Double-Blind, Placebo-Controlled Study of the Vasoconstrictor Potency of Topical 0.25% Desoximetasone Spray: A High to Super High Range of Potency (Class I to Class II) Corticosteroid Formulation.
    Journal of drugs in dermatology : JDD, 2017
    Co-Authors: Elias Oussedik, Mohammed D. Saleem, Steven R. Feldman
    Abstract:

    BACKGROUND Topical corticosteroids offer great efficacy in controlling a wide variety of dermatoses. Traditional ointment vehicles are messy and difficult to apply, which might limit adherence. Alternative vehicle formulations such as topical sprays might improve adherence due to their ease of application. The potency of Desoximetasone spray is not fully characterized. OBJECTIVE To evaluate the relative vasoconstrictive potency of Desoximetasone 0.25% topical spray formulation. METHODS This is a randomized, blinded, single-center study comparing the vasoconstrictive properties of Desoximetasone 0.25% topical spray to placebo and seven other known potency topical corticosteroid formulations. The primary endpoint was the degree of vasoconstriction measured using a colorimeter device. RESULTS Thirty-two healthy subjects met eligibility criteria. Desoximetasone 0.25% topical spray (REGWQ Grouping = A) showed a trend toward greater vasoconstrictive potency compared to clobetasol propionate 0.05% spray (REGWQ Grouping = A). No adverse or serious events were reported. LIMITATIONS The trial enrolled 90% females, which may affect the external validity of the study. Different populations may respond differently to Desoximetasone spray. CONCLUSIONS Desoximetasone 0.25% topical spray is a high to super high range of potency (Class I to Class II) steroid formulation. Given the cosmetic acceptability of spray products, we anticipate that this type of product would be highly effective for the treatment of inflammatory diseases in clinical practice. J Drugs Dermatol. 2017;16(10):972-975. .

  • a randomized double blind placebo controlled study of the vasoconstrictor potency of topical 0 25 Desoximetasone spray a high to super high range of potency class i to class ii corticosteroid formulation
    Journal of Drugs in Dermatology, 2017
    Co-Authors: Elias Oussedik, Mohammed D. Saleem, Steven R. Feldman
    Abstract:

    BACKGROUND Topical corticosteroids offer great efficacy in controlling a wide variety of dermatoses. Traditional ointment vehicles are messy and difficult to apply, which might limit adherence. Alternative vehicle formulations such as topical sprays might improve adherence due to their ease of application. The potency of Desoximetasone spray is not fully characterized. OBJECTIVE To evaluate the relative vasoconstrictive potency of Desoximetasone 0.25% topical spray formulation. METHODS This is a randomized, blinded, single-center study comparing the vasoconstrictive properties of Desoximetasone 0.25% topical spray to placebo and seven other known potency topical corticosteroid formulations. The primary endpoint was the degree of vasoconstriction measured using a colorimeter device. RESULTS Thirty-two healthy subjects met eligibility criteria. Desoximetasone 0.25% topical spray (REGWQ Grouping = A) showed a trend toward greater vasoconstrictive potency compared to clobetasol propionate 0.05% spray (REGWQ Grouping = A). No adverse or serious events were reported. LIMITATIONS The trial enrolled 90% females, which may affect the external validity of the study. Different populations may respond differently to Desoximetasone spray. CONCLUSIONS Desoximetasone 0.25% topical spray is a high to super high range of potency (Class I to Class II) steroid formulation. Given the cosmetic acceptability of spray products, we anticipate that this type of product would be highly effective for the treatment of inflammatory diseases in clinical practice. J Drugs Dermatol. 2017;16(10):972-975. .

Jerry Bagel - One of the best experts on this subject based on the ideXlab platform.

  • An Open-label, Observational Study Evaluating Desoximetasone Topical Spray 0.25% in Patients with Scalp Psoriasis.
    The Journal of clinical and aesthetic dermatology, 2018
    Co-Authors: Jerry Bagel, Elise Nelson
    Abstract:

    Objective: The goal of this study was to evaluate efficacy and safety of Desoximetasone spray 0.25%, a topical corticosteroid, in the management of scalp and body psoriasis. Design: This was an open-label, observational study. Participants: Twenty adults aged 18 years or older with chronic scalp psoriasis present on at least 30 percent of the scalp surface area and an Investigator Global Assessment (IGA) scale score of scalp disease of at least 2 on a scale of 0 to 4 were included in the study. Measurements: Study spray was applied twice daily for four weeks, followed by 12 weeks of twice-daily application for two consecutive days weekly. Results: At Week 4, the mean Physician Global Assessment (PGA) scale score had decreased 54.8 percent, from moderate disease to almost clear. Body surface area (BSA) had decreased by 51.2 percent, BSA × PGA had decreased by 63 percent, and scalp IGA had decreased by 64.5 percent from moderate to almost clear. Additionally, mean Psoriasis Scalp Severity Index (PSSI) score was 27.3±10.0 at baseline and decreased 82.4 percent to 4.8±5.2 and scalp surface area (SSA) was reduced by 70.7 percent at Week 4. The initial Scalp Index score was a mean of 65.7±15.0 at baseline and was reduced by 44.3 percent and 40.8 percent at Weeks 4 and 16, respectively. The initial response was maintained after a change to twice-weekly, twice-daily dosing, with a 48.4-percent decrease in PGA, a 17.1-percent decrease in BSA, a 31.5-percent decrease in BSA × PGA, a 51.6-percent decrease in scalp IGA, a 63.4 percent decrease in PSSI, and a 42.3-percent decrease in SSA seen at Week 16. Minimal adverse events were experienced by seven subjects. Conclusion: Desoximetasone spray 0.25% produced rapid improvements in PGA, BSA, BSA×PGA, scalp IGA, PSSI, SSA.

  • an open label observational study evaluating Desoximetasone topical spray 0 25 in patients with scalp psoriasis
    The Journal of clinical and aesthetic dermatology, 2018
    Co-Authors: Jerry Bagel, Elise Nelson
    Abstract:

    Objective: The goal of this study was to evaluate efficacy and safety of Desoximetasone spray 0.25%, a topical corticosteroid, in the management of scalp and body psoriasis. Design: This was an open-label, observational study. Participants: Twenty adults aged 18 years or older with chronic scalp psoriasis present on at least 30 percent of the scalp surface area and an Investigator Global Assessment (IGA) scale score of scalp disease of at least 2 on a scale of 0 to 4 were included in the study. Measurements: Study spray was applied twice daily for four weeks, followed by 12 weeks of twice-daily application for two consecutive days weekly. Results: At Week 4, the mean Physician Global Assessment (PGA) scale score had decreased 54.8 percent, from moderate disease to almost clear. Body surface area (BSA) had decreased by 51.2 percent, BSA × PGA had decreased by 63 percent, and scalp IGA had decreased by 64.5 percent from moderate to almost clear. Additionally, mean Psoriasis Scalp Severity Index (PSSI) score was 27.3±10.0 at baseline and decreased 82.4 percent to 4.8±5.2 and scalp surface area (SSA) was reduced by 70.7 percent at Week 4. The initial Scalp Index score was a mean of 65.7±15.0 at baseline and was reduced by 44.3 percent and 40.8 percent at Weeks 4 and 16, respectively. The initial response was maintained after a change to twice-weekly, twice-daily dosing, with a 48.4-percent decrease in PGA, a 17.1-percent decrease in BSA, a 31.5-percent decrease in BSA × PGA, a 51.6-percent decrease in scalp IGA, a 63.4 percent decrease in PSSI, and a 42.3-percent decrease in SSA seen at Week 16. Minimal adverse events were experienced by seven subjects. Conclusion: Desoximetasone spray 0.25% produced rapid improvements in PGA, BSA, BSA×PGA, scalp IGA, PSSI, SSA.

  • Open-Label, Observational Pilot Study Evaluating Desoximetasone Topical Spray 0.25% Twice Daily in Patients With Psoriasis Being Treated With Biologic Agents:
    Journal of Psoriasis and Psoriatic Arthritis, 2018
    Co-Authors: Jerry Bagel, Elise Nelson, Brian Keegan
    Abstract:

    Biologic therapy has been an important addition to the armamentarium of psoriasis drugs as they offer high efficacy with a better side effect profile than systemic agents. However, there are cases ...

  • open label observational pilot study evaluating Desoximetasone topical spray 0 25 twice daily in patients with psoriasis being treated with biologic agents
    Journal of Psoriasis and Psoriatic Arthritis, 2018
    Co-Authors: Jerry Bagel, Elise Nelson, Brian Keegan
    Abstract:

    Biologic therapy has been an important addition to the armamentarium of psoriasis drugs as they offer high efficacy with a better side effect profile than systemic agents. However, there are cases ...

  • clinical study results of Desoximetasone spray 0 25 in moderate to severe plaque psoriasis
    Journal of Drugs in Dermatology, 2013
    Co-Authors: Leon H Kircik, Mark Lebwohl, James Q. Del Rosso, Jerry Bagel, Linda Stein Gold, Jonathan S. Weiss
    Abstract:

    Two Phase 3, double-blind, randomized, vehicle-controlled parallel studies evaluated the efficacy and safety of Desoximetasone spray 0.25%, a super-potent topical corticosteroid, twice daily vs vehicle spray twice daily for 28 days in adult patients with moderate to severe plaque psoriasis. At baseline and throughout the study, the severity of disease for the psoriatic lesions was assessed using the Physician Global Assessment (PGA) score and a target lesion was assessed using the Total Lesion Severity Score (TLSS). A designated psoriatic plaque lesion was selected as the target lesion upon enrollment and evaluated throughout the study to determine the TLSS. To qualify for study entry, the subject needed to exhibit a PGA score of 3 (moderate) or 4 (severe) for overall disease severity, and a target lesion with an area of at least 5 cm(2) that achieved a combined score TLSS of >=7, with a plaque elevation score of >=3 (at least moderate). The mean % BSA affected by psoriasis ranged from 13%-17% at baseline. In both Phase 3 studies, a statistically significantly greater percentage of subjects in the Desoximetasone spray 0.25% compared to vehicle group achieved both Clinical Success and Treatment Success at Day 28. These results, which were the primary efficacy variables, demonstrated superior efficacy in the active study group for both overall improvement of plaque psoriasis (by PGA) and in the individual psoriasis lesion (by TLSS) designated at baseline as the most severely involved plaque (target lesion). Assessment of secondary efficacy variables in both Phase 3 studies showed that subjects receiving Desoximetasone Spray 0.25% twice daily exhibited statistically significantly mean changes from Baseline to Day 28 in PGA, TLSS, and % BSA affected when compared to subjects receiving vehicle spray twice daily. Tolerability and safety were assessed at all study visits. No statistically significant differences were observed between study arms and no major safety signals related to AEs were noted. No stinging and burning were reported with the spray formulation. This Class I topical corticosteroid has shown to be safe and efficacious in moderate to severe plaque psoriasis.