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.

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.

Is topical treatment effective for psoriasis in patients who failed topical treatment?

Objectives: 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.

Patients preferences for different corticosteroid vehicles are highly variable.

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.

Desoximetasone 0.25% spray, adrenal suppression and efficacy in extensive plaque psoriasis.

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 apply and may be an option for treating extensive psoriasis. OBJECTIVE: To evaluate the potential for hypothalamic-pituitary-adrenal axis suppression and efficacy of topical desoximetasone 0.25% spray formulation in patients with extensive psoriasis. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

Topical 0.25% desoximetasone spray efficacy for moderate to severe plaque psoriasis: a randomized clinical 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.

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.

[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.

Macroglossia. An unusual presentation of pemphigus vulgaris.

A 19-year-old woman presented with macroglossia of five months' duration and without bullae or erosions. A biopsy revealed a picture consistent with pemphigus vulgaris. The patient subsequently developed typical oral erosions. Her tongue enlargement and oral ulcerations improved dramatically with topical and systemic steroid therapy. Pemphigus vulgaris should be considered in the differential diagnosis of macroglossia.

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.

Compatibility of desoximetasone and tacrolimus.

The physical and chemical compatibility of desoximetasone ointment 0.25% and tacrolimus ointment 0.1%, both widely used to treat atopic dermatitis, were determined. A 1:1 (w/w) mixture of desoximetasone ointment 0.25% (Topicort, Taro Pharmaceuticals USA, Inc.) and tacrolimus ointment 0.1% (Protopic, Fujisawa Healthcare, Inc.) were prepared and stored under three different temperature/relative humidity conditions: 25 degrees C/60% RH; 30 degrees C/60% RH; and 40 degrees C/75% RH. Unmixed ointments stored under the same temperature and humidity conditions as the mixture served as controls. Samples were evaluated at days 1, 2, 7, 14, and 28 for color, degree of physical separation, and chemical stability via reverse-phase high performance liquid chromatography. Ranges of relative recovery for each active ingredient for all storage conditions ((% Mixture/% Control) x 100) were 89.6-109.3% for tacrolimus and 99.0-103.4% for desoximetasone. No significant difference in physical appearance or chromatographic profile between the mixture and controls was observed. Therefore, we conclude that desoximetasone ointment 0.25% (Topicort) and tacrolimus ointment 0.1% (Protopic) are physically and chemically compatible up to four weeks when mixed in a ratio of 1:1 (w/w).

A double-blind comparison of 0.25% and 0.05% desoxymethasone, 0.1% betamethasone valerate and 1% hydrocortisone creams in the treatment of eczema.

The efficacy and acceptability of 0.25% and 0.05% desoxymethasone, 0.1% betamethasone valerate and 1% hydrocortisone creams were compared in patients with eczema. A double-blind parallel group multi-centre design was employed in which 96 patients were recruited by four centres. Patients used one cream for a 3-week period and follow-up assessment visits were made at weekly intervals. Efficacy variables were: erythema/redness, scaling, itching and extent of area affected. These variables were assessed by both the investigator and the patient. The 0.25% desoxymethasone was the most effective treatment, producing the greatest degree of improvement in all clinical parameters, hydrocortisone was the least effective and 0.05% desoxymethasone was of intermediate effectiveness. The 0.1% betamethasone produced similar results to 0.25% desoxymethasone for half the assessments; for the other half the results were similar to 0.05% desoxymethasone. No adverse effects were reported during the study. The results are discussed in terms of physical properties of the vehicles and corticosteroid potency.

[Comparative study of 2 topical steroids preparations: desoximetasone and betamethasone dipropionate]. / Estudio comparativo entre dos preparados con esteroides tópicos: desoximetasona y dipropionato de betametasona.

Effectiveness of two creams, one containing desoxymethasone 0.25%, the other betamethasone dipropionate 0.05% was compared double blind, intraindividually. The preparations were used in symmetric areas of psoriasis. Final evaluation shows desoxymethasone cream to be significantly more active concerning reduction of erythema and overall improvement of lesions.

[Parallel double-blind comparison of bazalin and desoximetasone 0.25 in neurodermatitis]. / Estudio comparativo doble ciego paralelo entre bazalín y desoximetasona 0.25 en neurodermatitis.

In a double-blind study on 22 patients affected by neurodermitis the action of two ointmes was studied. Both possess an activity in controlling the clinical and histological manifestations of the disease. Desoximethasone (red labelled tubes) is very usefull in controlling pruritus and, histologically, the epidermal component of the lesions. Bazalin (yellow labeled tubes containing fluocinolone acetonide 0.025%, leucobitupal 5% an salicylic acid 3%), has a higher antiscaling action a more intense activity on the dermal component of the lesions.