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Journal of Drugs in Dermatology : JDD Aug 2015Data from two Phase 3, double-blind, randomized, vehicle-controlled parallel studies were evaluated to determine the efficacy and safety of twice daily desoximetasone... (Randomized Controlled Trial)
Randomized Controlled Trial
Data from two Phase 3, double-blind, randomized, vehicle-controlled parallel studies were evaluated to determine the efficacy and safety of twice daily desoximetasone 0.25% spray for the treatment of plaque psoriasis. In addition to global disease assessments, scaling assessments were performed at baseline and at weeks 1, 2, and 4. To qualify for inclusion, subjects were required to have a clinical diagnosis of stable plaque psoriasis involving ≥10% of the body surface area (BSA), a combined target lesion severity score (TLSS) of ≥7 for the target lesion, a plaque elevation score of ≥3 (moderate) for the target lesion, and a Physician Global Assessment (PGA) score of 3 (moderate) or 4 (severe) at baseline for the overall disease severity. At the baseline visit, the mean proportions of BSA affected by psoriasis were 17% (range 10% to 86%) in the desoximetasone 0.25% spray group and 16% (range 10% to 70%) in the vehicle spray group. Approximately 90% of the patients in each group had moderate to very severe scaling at baseline. Desoximetasone 0.25% spray was effective with significant improvements in overall severity and was well tolerated, with dryness, irritation, and pruritus at the application site being the only reported adverse events occurring in >1% of patients, each of which occurred in less than 3% of patients. As a large proportion of psoriasis patients (94%) have reported being bothered by scaling, the relief of scaling was examined in these studies. At week 1, 69.7% of patients on desoximetasone 0.25% spray had scaling that was considered clear / almost clear / mild compared with 48.3% for those on vehicle spray ( P = .0027). By week 4, the proportion of patients with clear / almost clear / mild scaling had risen to 83.9% in the desoximetasone 0.25% spray group (P < .0001). After four weeks of treatment, 66.4% of patients in the topical corticosteroid group had an overall improvement of at least two grades of disease severity. This demonstrates that desoximetasone 0.25% spray provided fast and effective relief of scaling in patients with plaque psoriasis affecting 10% to 86% of their BSA.
Topics: Adolescent; Adult; Aged; Anti-Inflammatory Agents; Body Surface Area; Desoximetasone; Double-Blind Method; Female; Humans; Male; Middle Aged; Psoriasis; Severity of Illness Index; Treatment Outcome; Young Adult
PubMed: 26267727
DOI: No ID Found -
The Medical Letter on Drugs and... Jun 2020
Topics: Administration, Cutaneous; Administration, Oral; Animals; Dermatitis, Atopic; Dermatologic Agents; Humans; Injections
PubMed: 32555122
DOI: No ID Found -
The Journal of Dermatological Treatment Feb 2018Traditionally, ointments were the vehicle of choice for psoriasis. Poor adherence of traditional vehicles limits the use of topical corticosteroids. Alternative... (Randomized Controlled Trial)
Randomized Controlled Trial
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 popularity due to their ease of application, improved adherence and efficacy.
OBJECTIVE
To evaluate the efficacy of topical desoximetasone 0.25% spray formulation in extensive psoriasis.
METHODS
This multicenter, double-blinded, randomized trial compared twice daily topical 0.25% desoximetasone spray to placebo in subjects ≥18 with moderate to severe plaque psoriasis. Primary outcome of the study was the proportion of subjects in each group that achieved clinical success (Physician Global Assessment [PGA] of 0 or 1) and/or treatment success at (target lesion score of 0 or 1) day 28.
RESULTS
One-hundred-and-twenty subjects were enrolled. At baseline, 75.0% and 73.3% of the treatment and placebo group had at least moderate PGA, respectively. Clinical success in the intended-to treat and placebo group was 30% and 5% (p = .0003), respectively; treatment success was 39% and 7% (p < .0001), respectively.
LIMITATIONS
The lack of standardized outcomes for topical psoriasis treatments limits the ability to compare the results to other treatments.
CONCLUSIONS
Topical desoximetasone spray provides rapid control of moderate to severe psoriasis lesions and may be considered for patients awaiting approval of biologicals.
TRIAL REGISTRATION
Clinical Trial was registered at clinicaltrial.gov: NCT01206387.
Topics: Administration, Topical; Adult; Aged; Aged, 80 and over; Dermatologic Agents; Desoximetasone; Double-Blind Method; Drug Administration Schedule; Drug Compounding; Female; Humans; Male; Middle Aged; Placebo Effect; Psoriasis; Severity of Illness Index; Treatment Outcome; Young Adult
PubMed: 28504031
DOI: 10.1080/09546634.2017.1331027 -
Turkish Journal of Pharmaceutical... Sep 2021Desoximetasone (DMS) is a widely recommended drug for the topical treatment of plaque psoriasis. However, low water solubility and short half life of DMS present major...
OBJECTIVES
Desoximetasone (DMS) is a widely recommended drug for the topical treatment of plaque psoriasis. However, low water solubility and short half life of DMS present major obstacles in the development of an effective topical formulation. Thus, there is a demand for the development of a safe and effective topical system to deliver hydrophobic DMS. The present study aimed to develop an -based emulgel formulation to ensure enhanced skin deposition of DMS for effective treatment of plaque psoriasis.
MATERIALS AND METHODS
Different formulations (DE1-DE4) of emulgel were prepared using dispersion technique, wherein varying concentrations of propylene glycol (6-14% w/w) and carbopol 934 (0.5-1.0% w/w) were used.
RESULTS
Zetasizer measurements revealed that the globule size of the formulations ranged from 10.34 µm±0.9 to 14.60 µm±1.4 (n=50). Extrudability analysis for the DE3 and DE2 formulations revealed an extrudability of 5.6±0.11 g/cm and 5.8±0.13 g/cm, respectively. The pH of the formulations was recorded in the range of 5.8-6.8. Among these formulations, DE3 showed a maximum drug content of 94.64%±0.29 (n=3), and thus was used for further evalutions. A texture analyzer showed that an optimized DE3 formulation was firmer and exhibited optimal spreadability in comparison with the DE2 formulation. For DE3, the mean max force that represented "firmness" was recorded to be 833.37 g, where as the mean area, denoting "work of shear", was 324.230 g.sec. The DE3 formulation exhibited DMS permeation of 95.40±1.6% over a period of 7 h, as detrmined using an in house fabricated Franze diffusion cell. Evaluation of release kinetics revealed that the release of DMS fitted into the Korsmeyer-Peppas model.
CONCLUSION
Physicochemical characteristics and enhanced permeation of DMS from emulgel highlight its suitability to be efficiently employed for the topical treatment of skin ailments.
PubMed: 34496553
DOI: 10.4274/tjps.galenos.2020.33239 -
Dermatologic Therapy Jul 2019Topical potent corticosteroids are the mainstay of treatment for chronic hand eczema (CHE). However, there are numerous adverse effects associated with the chronic use... (Comparative Study)
Comparative Study Randomized Controlled Trial
Topical potent corticosteroids are the mainstay of treatment for chronic hand eczema (CHE). However, there are numerous adverse effects associated with the chronic use of topical corticosteroids. Calcipotriol has been widely used in psoriasis and has been reported to achieve beneficial effects in several inflammatory diseases. This study aimed to evaluate the efficacy and safety of calcipotriol ointment compared to desoximetasone ointment in the treatment of CHE. Patch testing was performed in all recruited subjects. Then, each hand of the patient was randomly allocated for the application of either calcipotriol ointment or desoximetasone ointment twice daily for 8 weeks. Recurrence was assessed 4 weeks after discontinuation of the treatment. The Hand eczema severity index (HECSI) scores, quartile grading assessments and digital photographs were evaluated. Adverse reactions were also monitored. A total of 13 participants completed the protocol. Mean HECSI scores revealed up to a 75% reduction in both treatments (p < .001) without significant differences between the groups (p > .05). Approximately 70% of the subjects reported more than 75% improvement with calcipotriol at the end of the treatment. Mild scaling and mild dryness were the most common reactions found with calcipotriol and desoximetasone, respectively. In conclusion, calcipotriol ointment is safe and as effective as desoximetasone ointment. Calcipotriol ointment may be an alternative treatment option for CHE.
Topics: Administration, Cutaneous; Adult; Aged; Calcitriol; Chronic Disease; Dermatologic Agents; Desoximetasone; Double-Blind Method; Eczema; Female; Glucocorticoids; Hand Dermatoses; Humans; Male; Middle Aged; Ointments; Prospective Studies; Treatment Outcome
PubMed: 31070845
DOI: 10.1111/dth.12956 -
Analytical and Bioanalytical Chemistry Nov 2023Over the last decade, applications of ion mobility-mass spectrometry (IM-MS) have exploded due primarily to the widespread commercialization of robust instrumentation...
Over the last decade, applications of ion mobility-mass spectrometry (IM-MS) have exploded due primarily to the widespread commercialization of robust instrumentation from several vendors. Unfortunately, the modest resolving power of many of these platforms (~40-60) has precluded routine separation of constitutional and stereochemical isomers. While instrumentation advances have pushed resolving power to >150 in some cases, chemical approaches offer an alternative for increasing resolution with existing IM-MS instrumentation. Herein we explore the utility of two reactions, derivatization by Girard's reagents and 1,1-carbonyldiimidazole (CDI), for improving IM separation of steroid hormone isomers. These reactions are fast (≤30 min), simple (requiring only basic lab equipment/expertise), and low-cost. Notably, these reactions are structurally selective in that they target carbonyl and hydroxyl groups, respectively, which are found in all naturally occurring steroids. Many steroid hormone isomers differ only in the number, location, and/or stereochemistry of these functional groups, allowing these reactions to "amplify" subtle structural differences and improve IM resolution. Our results show that resolution was significantly improved amongst CDI-derivatized isomer groups of hydroxyprogesterone (two-peak resolution of R = 1.10 between 21-OHP and 11B-OHP), deoxycortisone (R = 1.47 between 11-DHC and 21-DOC), and desoximetasone (R = 1.98 between desoximetasone and fluocortolone). Moreover, characteristic collision cross section (CCS) measurements can be used to increase confidence in the identification of these compounds in complex biological mixtures. To demonstrate the feasibility of analyzing the derivatized steroids in complex biological matrixes, the reactions were performed following steroid extraction from urine and yielded similar results. Additionally, we applied a software-based approach (high-resolution demultiplexing) that further improved the resolving power (>150). Overall, our results suggest that targeted derivatization reactions coupled with IM-MS can significantly improve the resolution of challenging isomer groups, allowing for more accurate and efficient analysis of complex mixtures.
PubMed: 37740752
DOI: 10.1007/s00216-023-04953-8 -
Journal of Cutaneous Medicine and... 2019Topical corticosteroids (TS) are a treatment for atopic dermatitis (AD) and psoriasis (Ps). We assessed whether use of a TS under conditions designed to enhance... (Randomized Controlled Trial)
Randomized Controlled Trial
PURPOSE:
Topical corticosteroids (TS) are a treatment for atopic dermatitis (AD) and psoriasis (Ps). We assessed whether use of a TS under conditions designed to enhance adherence would be effective in patients who "failed" TS in the outpatient setting.
METHODS:
Individuals with treatment-resistant Ps or AD were recruited (AD, n = 12; Ps, n = 12). Six participants were randomized to each of 2 groups of desoximetasone 0.25% spray alone (n = 6) or desoximetasone spray plus twice-daily phone call reminders to use the medication. Disease severity was assessed.
RESULTS:
In treatment-resistant Ps patients, desoximetasone spray, with reminders, resulted in statistically significant improvement in all outcome measures. In treatment-resistant AD patients, there was statistically significant improvement in some assessments. Despite the very small sample size and short evaluation time, statistically significant changes were detected in this cohort. This is evidence of the large effect size of TS for Ps and AD when the treatment is used.
CONCLUSIONS:
Patients with "treatment-resistant" Ps and AD generally responded well to the use of desoximetasone spray in the trial setting. This may be due to better adherence in the study environment or patients' preference for the spray vehicle. Patient reminders contributed to improved clinical outcomes in Ps and AD patients with "treatment-resistant" disease.
Topics: Administration, Cutaneous; Adult; Aged; Anti-Inflammatory Agents; Dermatitis, Atopic; Desoximetasone; Drug Resistance; Female; Humans; Male; Medication Adherence; Middle Aged; Psoriasis; Reminder Systems; Severity of Illness Index; Telephone; Young Adult
PubMed: 30556414
DOI: 10.1177/1203475418818082 -
The Journal of Clinical and Aesthetic... May 2018The 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. This...
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. This was an open-label, observational study. 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. Study spray was applied twice daily for four weeks, followed by 12 weeks of twice-daily application for two consecutive days weekly. 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. Desoximetasone spray 0.25% produced rapid improvements in PGA, BSA, BSA×PGA, scalp IGA, PSSI, SSA.
PubMed: 29785235
DOI: No ID Found -
Experimental Cell Research Oct 2020SARS-CoV2, the agent responsible for the current pandemic, is also causing respiratory distress syndrome (RDS), hyperinflammation and high mortality. It is critical to...
BACKGROUND
SARS-CoV2, the agent responsible for the current pandemic, is also causing respiratory distress syndrome (RDS), hyperinflammation and high mortality. It is critical to dissect the pathogenetic mechanisms in order to reach a targeted therapeutic approach.
METHODS
In the present investigation, we evaluated the effects of SARS-CoV on human bronchial epithelial cells (HBEC). We used RNA-seq datasets available online for identifying SARS-CoV potential genes target on human bronchial epithelial cells. RNA expression levels and potential cellular gene pathways have been analyzed. In order to identify possible common strategies among the main pandemic viruses, such as SARS-CoV, SARS-CoV1, MERS-CoV, and H1N1, we carried out a hypergeometric test of the main genes transcribed in the cells of the respiratory tract exposed to these viruses.
RESULTS
The analysis showed that two mechanisms are highly regulated in HBEC: the innate immunity recruitment and the disassembly of cilia and cytoskeletal structure. The granulocyte colony-stimulating factor (CSF3) and dynein heavy chain 7, axonemal (DNAH7) represented respectively the most upregulated and downregulated genes belonging to the two mechanisms highlighted above. Furthermore, the carcinoembryonic antigen-related cell adhesion molecule 7 (CEACAM7) that codifies for a surface protein is highly specific of SARS-CoV and not for SARS-CoV1, MERS-CoV, and H1N1, suggesting a potential role in viral entry. In order to identify potential new drugs, using a machine learning approach, we highlighted Flunisolide, Thalidomide, Lenalidomide, Desoximetasone, xylazine, and salmeterol as potential drugs against SARS-CoV infection.
CONCLUSIONS
Overall, lung involvement and RDS could be generated by the activation and down regulation of diverse gene pathway involving respiratory cilia and muscle contraction, apoptotic phenomena, matrix destructuration, collagen deposition, neutrophil and macrophages recruitment.
Topics: Bronchi; COVID-19; Carcinoembryonic Antigen; Coronavirus Infections; Drug Discovery; Dyneins; GPI-Linked Proteins; Gene Regulatory Networks; Granulocyte Colony-Stimulating Factor; Humans; Immunity, Innate; Machine Learning; Pandemics; Pneumonia, Viral; Respiratory Mucosa; Transcriptome; Up-Regulation
PubMed: 32735892
DOI: 10.1016/j.yexcr.2020.112204 -
The Journal of Dermatological Treatment Feb 2021: To determine if resistance to topical treatments can be overcome under conditions promoting adherence.: Twelve psoriasis patients treated with topical 0.25%... (Clinical Trial)
Clinical Trial
: To determine if resistance to topical treatments can be overcome under conditions promoting adherence.: 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.: Most subjects improved in most scoring parameters. 100%, 91.7%, 83.3%, and 58.3% had improvements in itching, PASI, TLSS, and IGA, respectively.: While our sample size was small and treatment duration short, the effect size of topical treatment was large under conditions designed to promote adherence.
Topics: Administration, Topical; Adult; Aged; Desoximetasone; Drug Administration Schedule; Female; Glucocorticoids; Humans; Male; Middle Aged; Psoriasis; Severity of Illness Index; Treatment Outcome
PubMed: 31132897
DOI: 10.1080/09546634.2019.1617830