Desoximetasone

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

J Drugs Dermatol 2015 Aug;14(8):835-40.PMID:26267727doi

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.

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

Cutis 2006 Nov;78(5):357-63.PMID:17186796doi

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.

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

J Dermatolog Treat 2018 Feb;29(1):36-38.PMID:28494626DOI:10.1080/09546634.2017.1329508.

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.

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

Int J Mol Sci 2021 Feb 3;22(4):1535.PMID:33546426DOI:10.3390/ijms22041535.

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.

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

J Drugs Dermatol 2017 Aug 1;16(8):755-758.PMID:28809990doi

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.