Nanostructured Non-Ionic Surfactant Carrier-Based Gel for Topical Delivery of Desoximetasone.

Psoriasis is a chronic autoimmune skin disease impacting the population globally. Pharmaceutical products developed to combat this condition commonly used in clinical settings are IV bolus or oral drug delivery routes. There are some major challenges for effectively developing new dosage forms for topical use: API physicochemical nature, the severity of the disease state, and low bioavailability present challenges for pharmaceutical product developers. For non-severe cases of psoriasis, topical drug delivery systems may be preferred or used in conjunction with oral or parenteral therapy to address local symptoms. Elastic vesicular systems, termed "niosomes", are promising drug delivery vehicles developed to achieve improved drug delivery into biological membranes. This study aimed to effectively incorporate a corticosteroid into the niosomes for improving the drug bioavailability of desoximetasone, used to treat skin conditions via topical delivery. Niosomes characterization measurements were drug content, pH, spreadability, specific gravity, content uniformity, rheology, and physicochemical properties. Formulations used a topical gelling agent, Carbomer 980 to test for in vitro skin permeation testing (IVPT) and accelerated stability studies. The developed niosomal test gel provided approximately 93.03 ± 0.23% to 101.84 ± 0.11% drug content with yield stresses ranging from 16.12 to 225.54 Pa. The permeated amount of desoximetasone from the niosomal gel after 24 h was 9.75 ± 0.44 µg/cm2 compared to 24.22 ± 4.29 µg/cm2 released from the reference gel tested. Furthermore, a drug retention study compared the test gel to a reference gel, demonstrating that the skin retained 30.88 ng/mg of desoximetasone while the reference product retained 26.01 ng/mg. A controlled drug release profile was obtained with a niosomal formulation containing desoximetasone for use in a topical gel formulation showing promise for potential use to treat skin diseases like psoriasis.

Calcipotriol ointment shows comparable efficacy to topical steroids in chronic hand eczema.

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.

Psoriasis and Atopic Dermatitis "Resistant" to Topical Treatment Responds Rapidly to Topical Desoximetasone Spray.

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.

Topical Desoximetasone 0.25% Spray and Its Vehicle Have Little Potential for Irritation or Sensitization.

BACKGROUND: Topical corticosteroids are the most common dermatologic medications and are available in numerous different vehicles. Adherence is limited by traditional vehicles because they are messy and time consuming to apply. The preferred spray formulations have the advantage of being applied with ease, resulting in improved adherence and subsequently improved psoriasis. One limitation of topical treatments, especially spray vehicles, is the potential for irritation and sensitization.

OBJECTIVE: To evaluate the irritation and sensitization potential of topical desoximetasone spray formulation.

METHODS: A multicenter, double-blinded, randomized, controlled study assessed the irritancy and sensitization of 0.25% and 0.05% topical desoximetasone spray. Controls included vehicle, a positive control (0.1% sodium lauryl sulfate), negative control (0.9% saline), and an active comparator control (clobetasol spray). The primary outcome of the study was to evaluate the difference in mean cumulative irritation and potential sensitization response of desoximetasone 0.25% and 0.05% topical sprays.

RESULTS: Of the 297 enrolled, 269 completed the study per protocol for the irritation phase and 250 completed the protocol for the sensitization phase. At 22 days, desoximetasone 0.25 and 0.5% spray were less irritating than clobetasol 0.05% spray; mean irritation score difference of -0.46 and -0.57, respectively. Median total irritation score over the 22 days was 0 for all products. No subjects demonstrated any sensitization reaction to any of the six products. No serious adverse reactions were reported.

LIMITATIONS: Selection bias, use of a healthy population, limits the external validity. In addition, the duration of the study was short lived, unlike numerous inflammatory skin diseases. CONCLUSIONS: Desoximetasone spray has little potential for irritation or sensitization. The availability of another spray option for patients desiring less messy treatment may facilitate better adherence and treatment outcomes.

J Drugs Dermatol. 2017;16(8):755-758.

Efficacy and Safety of Desoximetasone 0.25% Spray in Adult Atopic Dermatitis Subjects: Pilot Study.

BACKGROUND: Atopic dermatitis (AD) is a chronic, relapsing, inflammatory skin disorder. One of the most disturbing symptoms of AD is pruritus. The first line treatment for AD is topical corticosteroids, topical immunomodulators, topical barrier creams, oral antihistamines, and systemic treatments. Desoximetasone 0.25% spray is a superpotent topical corticosteroid delivered in a novel way and it may be a suitable option for the treatment of pruritus in adult atopic dermatitis patients. STUDY DESIGN: A single-center, open labeled pilot study was conducted to investigate the efficacy and safety of desoximetasone 0.25% spray for pruritus in adult atopic dermatitis patients. RESULTS: Twice daily application of desoximetasone 0.25% spray to affected areas resulted in a significant reduction in all outcomes (IGA, pruritus, VAS assessment of pruritus) within 1 week of initiation of treatment. The reductions exhibited were sustained throughout the study period of 4 weeks. Significant improvements in quality of life, as measured by the DLQI, were observed. No adverse events were reported. CONCLUSION: Desoximetasone 0.25% spray is effective for treating pruritic symptoms of AD. Given its efficacy and convenience as a spray, desoximetasone 0.25% spray should continue to be evaluated as a treatment for AD in larger trials.

J Drugs Dermatol. 2017;16(9):919-922.

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.

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.

Desoximetasone 0.25% Spray for the Relief of Scaling in Adults With Plaque Psoriasis.

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.

Clinical study results of desoximetasone spray, 0.25% in moderate to severe plaque psoriasis.

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.

Adherence to topical treatment can improve treatment-resistant moderate psoriasis.

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.

Activity of different desoximetasone preparations compared to other topical corticosteroids in the vasoconstriction assay.

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 bioavailability of different topical corticosteroid formulations in healthy human beings focussing on desoximetasone (DM). MATERIALS AND METHODS: Two DM 0.25% formulations [ointment (DM-o) and fatty ointment (DM-fo, water-free); class III corticosteroids], the corresponding active ingredient-free vehicles and three comparators of different strength [clobetasol propionate 0.05% (CP 0.05%), fatty ointment, class IV; hydrocortisone (HC) 1%, fatty ointment, class I, and betamethasone (BM) 0.05%, fatty ointment, class III] were tested using the vasoconstriction assay. The degree of vasoconstriction (blanching) in the treatment field was compared to the one found in untreated control fields using chromametric measurements and clinical assessment. RESULTS/CONCLUSION: DM-o 0.25%, DM-fo 0.25% and BM 0.05% showed similar vasoconstrictive potential, i.e., clear blanching. In fact, both DM preparations were proven to be noninferior to BM 0.05%, while CP 0.05% was found a little less active. HC 1.0% and the DM vehicles showed no clear-cut vasoconstrictive effect. No adverse events related to the study medications were observed. Good topical bioavailability of both DM formulations was detected by chromametric measurement and clinical assessment.

Etanercept responsive acrodermatitis continua of Hallopeau: is a pattern developing?

Acrodermatitis continua of Hallopeau (ACH) is a rare disease. Little is known about its etiology or relative effectiveness of the various therapeutic approaches. However, in the literature a pattern seems to be developing on successfully treated patients using biologic therapies. Here, we further emphasize the potential breakthrough presented by the novel immune based therapies. This report consists of a case of etanercept responsive ACH along with a brief review of the literature.

Cross-reactions to desoximetasone and mometasone furoate in a patient with multiple topical corticosteroid allergies.

A 60-year-old man developed a bullous contact dermatitis after topical corticosteroid treatment of dermatitis on his lower leg. Subsequent patch testing showed cross-reactions to numerous group B and group D corticosteroids as well as cross-reactions to group C desoximetasone and group D1 mometasone furoate. His patch-test result was negative for the group A corticosteroids hydrocortisone and tixocortol pivalate. We discuss the uncommon finding of cross-reactions to desoximetasone and mometasone furoate.

Desoximetasone 0.25% and tacrolimus 0.1% ointments versus tacrolimus alone in the treatment of atopic dermatitis.

Long-term in vitro compatibility of desoximetasone and tacrolimus ointments prompted the current trial in humans. We aimed to evaluate the efficacy of twice-daily simultaneous application of desoximetasone and tacrolimus in the treatment of atopic dermatitis versus tacrolimus monotherapy. Eighty-two subjects were treated in this multicenter, single-group, double-blinded, paired, 3-week follow-up clinical study of desoximetasone 0.25% and tacrolimus 0. 1% ointments versus tacrolimus 0.1% ointment and vehicle. Subjects were treated twice daily for 21 days or until clearing. Safety and efficacy were assessed at days 3, 7, 14, and 21. The combination of desoximetasone and tacrolimus ointment was superior to tacrolimus alone (P=.0002) in treating atopic dermatitis as measured by the summary of the scores for erythema, lichenification, pruritus, scaling/dryness, and oozing/crusting. Of note, pruritus at the application site was diminished in subjects treated with desoximetasone and tacrolimus together compared with tacrolimus alone (P=.04). Combination treatment with desoximetasone and tacrolimus offered increased efficacy and tolerability over tacrolimus alone in patients with atopic dermatitis.

[Psoriasis and mud bath therapy: clinical-experimental study]. / Psoriasi e fangobalneoterapia: studio clinico sperimentale.

OBJECTIVE: The psoriasis is chronic disease characterized from an acceleration of the kinetic of the cells of epidermis. To front of the empirical evidence of the benefits of the thermal therapy in the psoriasis, the experimentals-clinics studies is insufficient. The aim of research it has been that of quantify the benefits of the mud-bath therapy with mineral water in the psoriasis. PATIENT AND METHODS: The study has been channel on a champion of 30 subjects of which 19 of male sex and 11 of female sex with middle equal age to 56 years +/- 5.3 affected from psoriasis. The subjects of the examined champion have been divided to random in 2 groups: A and B. The group A has been treated with drugs used for psoriasis for 12 days; the B group has been treated, always for 12 consecutive days, with mud-bath therapy (FBT) with mineral water obtained from the mineral sources (chlorinate-sulphureous-bicarbonate) of the Spa of Stabia in Castellammare (NA). To the beginning and at the end of the advised treatments has been valued the prurient symptomatology and the PASI (Psoriasis and Severity Index). RESULTS: The data highlight an significant (P < 0.05) reduction is of the prurient symptomatology and of the PASI in both the groups considered. CONCLUSIONS: The results of this first step of investigations seems to highlight that the FBT treatment, to the same way of the drugs anti-psoriasis, results useful in the ameliorate the quality of life of these patients.

Multicenter study comparing 0.05% gel formulations of desoximetasone and fluocinonide in patients with scalp psoriasis.

A double-blind, multicenter study was conducted to evaluate and compare the safety and efficacy of desoximetasone gel 0.05% and fluocinonide gel 0.05% in patients with scalp psoriasis. One hundred twenty-five patients were enrolled in this randomized, parallel-group trial. Responses based on clinical assessment in 123 patients showed that the desoximetasone gel formulation is a safe and effective treatment for psoriasis of the scalp. Although efficacy appears equivalent to that of fluocinonide gel 0.05% in treating psoriasis of the scalp, desoximetasone appears to be slightly better tolerated and better accepted cosmetically.

Comparative study of desoximetasone ointment 0.25% versus fluocinonide ointment 0.05% in patients with psoriasis.

In a multicenter, investigator-blind study, desoximetasone ointment 0.25% was compared with fluocinonide ointment 0.05% in the treatment of patients with psoriasis. Evaluations were made before treatment and after 4, 7, and 14 days of treatment. Both drugs were shown to be safe and effective. Desoximetasone was significantly superior to fluocinonide in improving severity scores from baseline for thickening (days 7 and 14) and erythema (day 14); in numbers of subjects cleared of thickening (day 4); in overall evaluation ratings as compared to baseline (day 14); and in number of patients receiving an overall evaluation of excellent. No side effects were reported for either treatment group during the study.

Systemic absorption of topical steroids. Metabolic effects as an index of mild hypercortisolism.

This study was undertaken to determine whether the commonly used treatment of psoriasis with potent topical glucocorticoids results in hypercortisolism and whether metabolic changes might provide a means for monitoring pharmacologic effects of excessive systemic absorption of glucocorticoids. Plasma cortisol, glucose, and insulin and circulating polymorphonuclear leukocytes were assessed under controlled conditions in five otherwise healthy patients with psoriasis (40% to 85% involvement) treated with topical desoximetasone, without occlusion. In all patients, there were rapid and sustained suppression of endogenous cortisol production, twofold to threefold increases in fasting insulin levels indicating insulin resistance, and elevated levels of polymorphonuclear leukocytes. Two patients also experienced reduced glucose tolerance. These findings suggest that application of potent corticosteroids to large areas of diseased skin results in sufficient systemic absorption to cause not only adrenal suppression but some degree of hypercortisolism with greater frequency and rapidity than has been suggested. Prospective monitoring of insulin-glucose relationships as a sensitive index of the metabolic effects of glucocorticoids may provide a means of assessing excess systemic absorption that is not predictable on the basis of adrenal suppression or circulating levels of the drug. Such prediction could have particular relevance in anticipating adverse clinical effects in the treatment of chronic skin disorders with potent topical glucocorticoids.

A randomized, double-blind therapeutic trial of 0.25% desoxymethasone and 0.1% hydrocortisone 17-butyrate in the treatment of varicose eczema.

A double-blind, randomized trial was carried out in 60 patients with varicose (hypostatic) eczema to compare the efficacy and tolerance of treatment with 0.25% desoxymethasone in an oily cream base, the oily cream base alone, and 0.1% hydrocortisone 17-butyrate cream. The creams were applied twice daily and patients' progress followed for up to 38 days. Clinical ratings based on an assessment of individual signs and symptoms, the area of skin involved and the physician's overall impression demonstrated a significant difference from the oily cream base in favour of both active treatments within the first 10 days. No significant difference between the two active treatments was shown. All three treatments were well tolerated by the patients.