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A Review of Topical Corticosteroid Sprays for the Treatment of Inflammatory Dermatoses

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A Review of Topical Corticosteroid Sprays for the Treatment of Inflammatory Dermatoses Volume 25 Number 8| August 2019| Dermatology Online Journal || Review 25(8):3 A review of topical corticosteroid sprays for the treatment of inflammatory dermatoses Kyle A Habet1 MD, Sree S Kolli1 BA, Adrian Pona1 MD, Steven R Feldman1,2,3 MD PhD Affiliations: 1Center for Dermatology Research, Department of Dermatology, Wake Forest School of Medicine, Winston-Salem, North Carolina, 2Department of Pathology, Wake Forest School of Medicine, Winston-Salem, North Carolina, 3Department of Social Sciences & Health Policy, Wake Forest School of Medicine, Winston-Salem, North Carolina Corresponding Author: Kyle A. Habet, MD, Department of Dermatology, Wake Forest School of Medicine, Medical Center Boulevard, Winston-Salem, NC 27157-1071, Tel: 06 8616-0331, E-mail: [email protected] Introduction Abstract Topical corticosteroids are ubiquitous in the Background: Topical corticosteroids are available in treatment of various dermatoses [1]. Vehicles many vehicles. However, patients’ preference for available for topical corticosteroids include creams, vehicles are variable and could be tailored to ointments, gels, lotions, solutions, and sprays. maximize patient adherence. Spray vehicles may Although ointments, creams, and gels are often offer, convenience, and strong efficacy. prescribed, an increasing use of nontraditional Methods: A literature review was conducted using vehicles, including sprays and foams, are being keywords: clobetasol, desoximetasone, betamethasone, triamcinolone, corticosteroid, prescribed for psoriasis and other inflammatory topical, spray, vehicles, treatment, and clinical trial. dermatoses. Since patients have specific priorities for Results: For moderate-to-severe plaque psoriasis, topical vehicles, healthcare providers could explore 87% of subjects achieved an Overall Disease Severity patient preference for medication vehicles [2, 3]. (ODS) Score ≤2 at week two and 78% achieved an Patients may find topical sprays appealing since they ODS ≤1 after four weeks with clobetasol propionate are less messy, easy to apply, and leave minimal (CP) 0.05% spray compared to 17% and 3% in the residue. A study investigating the trending use of control group, respectively (P<0.001). For sunscreen vehicles reported an increased use of desoximetasone 0.25% spray, 31%-53% with sunscreen sprays and a decreased use of sunscreen moderate-to-severe psoriasis achieve Physician’s lotions because consumers felt that sunscreen sprays Global Assessment (PGA) score ≤1 at day 28 versus were quick and easy to apply [4]. Multiple factors 5%-18% in the vehicle spray group (P<0.01). For may influence a patient’s choice of vehicle but betamethasone dipropionate 0.05% spray, 19% with mild-to-moderate plaque psoriasis achieved an preference varies widely. Individualizing treatment Investigator’s Global Assessment (IGA) score ≤1 or a may optimize adherence [1, 5]. 2-grade reduction in IGA versus 2.3% in vehicle group Owing to an increasing popularity of nontraditional (P≤0.001). For mild-to-severe steroid responsive vehicles like sprays for topical therapy, this article will inflammatory dermatoses, 64% using triamcinolone review available topical corticosteroid sprays and acetonide 0.2% spray achieved clear or almost clear their efficacy and safety in treating certain skin at day 14 (no P value reported). Adverse events inflammatory skin conditions [3, 4]. including burning, irritation, and dryness were similar across all corticosteroids. Clobetasol propionate 0.05% spray Clobetasol propionate 0.05% spray is a class 1, super- Keywords: clobetasol, desoximetasone, triamcinolone, potent topical corticosteroid used for the treatment betamethasone, vehicle, psoriasis, atopic dermatitis, of moderate-to-severe plaque psoriasis. Clobetasol adherence proprionate 0.05% spray is FDA-approved for a 4- - 1 - Volume 25 Number 8| August 2019| Dermatology Online Journal || Review 25(8):3 week, twice daily application in patients 18 years or in the add-on therapy arm had to have at least one older [6]. Total dose should not exceed 50g of target plaque with TPS score of moderate to severe. product per week (59ml or two fluid ounces) to When clobetasol propionate spray was used as prevent HPA-axis suppression [6]. topical monotherapy, significant improvement from baseline was achieved in target plaque severity and Efficacy overall severity after 2 weeks of treatment. After 4 A multicenter, randomized, double-blind, vehicle- weeks of treatment, 80% of subjects achieved controlled, parallel-group, comparative study treatment success using topical monotherapy with evaluated the efficacy of clobetasol propionate clobetasol propionate 0.05% spray. Only 2% of 0.05% spray in 120 adults with moderate-to-severe subjects did not report grade improvement [8]. plaque psoriasis affecting at least 2% of their body Clobetasol propionate 0.05% spray was also effective surface area. A successful primary outcome was as additional topical therapy for patients already defined as Overall Disease Severity (ODS) score of ≤2 receiving topical or systemic antipsoriatic agent [9]. (mild, almost clear or clear) at week 2 and ODS score About 80% of subjects with a moderate-to-severe ≤1 (clear or almost clear) at week 4. Secondary plaque achieved complete or almost complete outcomes included reduction in disease severity for clearing at 4 weeks when clobetasol propionate psoriasis signs and symptoms (scaling, erythema, 0.05% spray was used as adjunctive therapy [9]. plaque elevation and pruritus) at weeks 1 and 8 and calculated treatment success (defined as clear or A multicenter, randomized, clinical trial of 122 almost clear) at week 8. Disease severity for psoriasis subjects with moderate-to-severe plaque psoriasis signs and symptoms were scored on a 5-point scale affecting 3 to 20% of body surface area compared (0=none, 1=almost clear, 2=mild, 3=moderate, efficacy and safety of clobetasol propionate 0.05% 4=severe, 5=very severe). Subjects were randomized spray to calcipotriene 0.005% mixed with in a 1:1 ratio to receive clobetasol propionate 0.05% betamethasone dipropionate 0.064% (C-BD) spray or vehicle. Subjects were instructed to apply ointment. Subjects were instructed to apply the study medication twice daily for 4 weeks. medication twice daily and assessed at week 1, 2, 4 Evaluations were conducted at baseline, weeks 1, 2, and 8 (4 weeks post-treatment). A successful primary 4, and 8. Superior results were achieved with outcome was defined as an ODS score of ≤1 and IGA clobetasol propionate 0.05% spray for both primary scale. Clobetasol propionate 0.05% spray efficacy and secondary outcomes (Table 1). A significant was greater than C-BD ointment with 75% of amount of subjects in the clobetasol group subjects achieving clear or almost clear skin (ODS ≤1) maintained treatment success 4 weeks post- after 4 weeks of treatment compared with 45% using treatment [7]. C-BD ointment. Both clobetasol propionate 0.05% A 4-week open-label observational study spray and C-BD ointment improved patient quality of investigated the efficacy of clobetasol propionate life without any significant differences between both 0.05% spray in subjects with psoriasis affecting 3% to groups. Compared with C-BD ointment, subjects 20% of their body surface area. Effectiveness was found clobetasol propionate 0.05% spray easier to apply and were more satisfied with their results [10]. measured using a 7-point Investigators’ Global Assessment of Improvement (GAI) scale A multicenter, double-blind clinical study (0=completely clear, 6=worsened) and a 6-point randomized 81 subjects with moderate-to-severe Target Plaque Severity (TPS) scale (0=clear, 5= very scalp psoriasis to a clobetasol propionate 0.05% severe). Treatment success was defined as a score of spray or vehicle spray applied twice daily. The 0 or 1 on GAI or on TPS or an improvement of 2 primary efficacy outcome was measured using the grades or more on TPS. Subjects were randomized to Global Severity Score (GSS) for scalp psoriasis at week a monotherapy arm (N=1254) or add-on therapy arm 4. Subjects who achieved a score of 0 at week 2 were (N=731) with another antipsoriatic agent in addition considered a treatment success and prematurely to clobetasol propionate 0.05% spray [8, 9]. Subjects completed the study. End of treatment was therefore - 2 - Volume 25 Number 8| August 2019| Dermatology Online Journal || Review 25(8):3 either at week 2 or 4, depending on GSS score. stinging/burning suggesting the alcohol content Secondary end points included GSS at week 2, may be attributed to the spray vehicle [7]. The most psoriasis individual sign scores, extent of scalp common adverse events reported were pruritus, involvement index, and pruritus at weeks 2 and 4. moderate erythema, peeling/scaling, dryness, and Additional assessment included Scalpdex (a stinging/burning. Telangiectasia, skin atrophy, and validated scalp dermatitis-specific quality of life folliculitis were reported in 1% of subjects [7-9]. Scalp instrument) score. Psoriasis individual sign scores psoriasis subjects treated with CP 0.05% spray rated scaling, erythema, and plaque elevation on a 4- reported burning/stinging (26%) and telangiectasia point scale. Extent of scalp involvement index was (3%) [11]. rated on a 5-point scale (0=none, 1= <20%, 2=20- Desoximetasone 0.25% spray 39%, 3=40-59%, 4=60-79% and 5=80-100%). Pruritus Desoximetasone 0.25% spray is a potent to super- was evaluated on a 3-point scale (0=no itching, potent topical corticosteroid [12]. Treatment 1=some itching, not bothersome, 2=definite itch, indication includes adults with moderate-to-severe bothersome and 3=intense itching). At week 2, 12% plaque psoriasis and atopic dermatitis. It can be used of subjects achieved treatment success (GSS=0) in up to 4 weeks and should be applied directly to the the clobetasol group compared with 0% in the affected site and rubbed in gently and completely placebo group whereas 68% of subjects in the [13]. It can provide rapid relief of scaling from intent-to-treat (ITT) group were almost clear psoriasis in up to 70% of patients in 1 week and 84% compared with 8% in the placebo group.
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