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.

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.

Six week evaluation of the potential for topical desoximetasone 0.25% spray to induce photoallergic skin reaction.

PURPOSE: Desoximetasone 0.25% topical spray is a novel formulation that has not been tested or approved for safety and efficacy. The primary objective was to determine the potential of desoximetasone 0.25 and 0.05% topical sprays, as well as a vehicle to induce photoallergic skin reaction after repeated topical application and irradiation to the skin using a controlled photopatch testing procedure. MATERIALS AND METHODS: 53 subjects completed the study, each with six application sites (two of each treatment), three of which were irradiated and three non-irradiated, for an induction period of three weeks and then challenge period at week 6. RESULTS: Desoximetasone 0.25 and 0.05%, as well as vehicle showed no evidence of potential to induce photosensitization. There was statistically significantly greater irritation at the vehicle irradiated site in comparison to the irradiated treatment area of desoximetasone 0.25% (p = .005) and the irradiated treatment area of desoximetasone 0.05% (p = .008). CONCLUSION: Our results suggest that regular treatment with desoximetasone 0.25 and 0.05% spray, followed by UV light exposure does not induce photosensitization or photo-irritation. These findings increase confidence for the use of this topical spray in eczema or psoriasis patients who may also be receiving UV light therapy and may contribute to the clinical management of these patients.

4-Day evaluation of the irritation potential of topical desoximetasone 0.25% and 0.05% spray on light-exposed skin.

PURPOSE: The safety and potential side effects of desoximetasone 0.25% and 0.05% sprays have not previously been studied. The primary objective of this study was to determine the irritation potential of desoximetasone 0.25%, 0.05% and vehicle sprays in response to irradiation. MATERIALS AND METHODS: Thirty-four subjects were enrolled in the study, each with three study treatments (desoximetasone 0.25%, 0.05% topical sprays and vehicle) were applied to two sites each on the back of every subject, with half of the sites irradiated with filtered UV light. Dermal reactions at the test sites were evaluated using a visual scale with corresponding numerical scores that rated the degree of erythema and oedema. RESULTS: Desoximetasone 0.25%, 0.05%, and vehicle caused no detectable signs of phototoxicity when examined on days 3 and 4. Mean scores of desoximetasone 0.25%, 0.05% and vehicle to non-irradiated treatment areas showed no signs of irritation. CONCLUSIONS: Our results suggest that regular application of desoximetasone 0.25% and 0.05% topical sprays do not induce photosensitization or photoirritation. The safety of this topical spray may help with clinical management of patients using topical corticosteroids while also receiving therapeutic UV light exposure. Thus, patients can use desoximetasone sprays without concerns of side effects due to therapeutic light or sun exposure.

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.

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.

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.

Iatrogenic hyperadrenocorticism and steatohepatitis caused by unapproved medicine.

A 54-year-old man experienced weight gain. He was diagnosed as having hyperglycemia, hypertension and liver damage. Liver biopsy showed steatohepatitis. We initially suspected him as having hyperadrenocorticism. However, both adrenocorticotropic hormone and cortisol levels were low. Later, it was revealed that he took medicine to relieve his gonalgia. His hyperglycemia, hypertension and liver damage improved after he discontinued taking the medicine. An analysis of this medicine showed that it contained desoximetasone, a glucocorticoid compound that had not been approved for medical use in Japan. To adequately diagnose clinical conditions, it is necessary to survey the patient's medicinal history in detail.

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.

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.

Cushing's syndrome from topical glucocorticoids.

A case of Cushing's syndrome is described in a woman who self-treated psoriasis with a variety of potent topical glucocorticoids over 15 years. She was successfully weaned off corticosteroids and was treated with alternative anti-psoriatic drugs. The disappearance, nine months later, of most features of Cushing's syndrome, and the normal suppression of cortisol in response to dexamethasone, excluded endogenous hypercorticolism. The apparent widespread availability across the counter of potent corticosteroids is a cause for concern.

Extensive visual loss with topical facial steroids.

Steroid creams applied topically to the skin are routinely used in the treatment of many dermatoses. Their use on the face in severe atopic eczema is relatively common. We report a series of three patients who whilst using topical facial steroids developed advanced glaucoma. A further two cases of ocular hypertension secondary to topical facial steroids are also described. This is the first series of cases to be reported demonstrating the potentially blinding complications of topical facial steroids. Recommendations are made with regard to screening such patients for glaucoma.

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.

[Cushing syndrome following external glucocorticoid administration in psoriasis]. / Cushing-Syndrom nach externer Glukokortikoid-Applikation bei Psoriasis.

We report on a 20-year-old patient suffering from psoriasis vulgaris who treated himself with high dosages of powerful topical corticosteroids (250 mg desoxymethasone a week). He developed Cushing's syndrome which disappeared after discontinuation of that therapy. In general, these cases are rare because of the low percutaneous resorption of these glucocorticoids being below ten percent in most anatomical regions.

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.