Clobetasol Emulsion Foam and Calcipotriene 0.005% Foam Combination Therapy for the Maintenance of Treatment Response in Patients With Moderate Plaque Psoriasis
March 2018 | Volume 17 | Issue 3 | Original Article | 342 | Copyright © 2018
Neal Bhatia MDa and Leon Kircik MDb
aTherapeutics Clinical Research, San Diego, CA bIcahn School of Medicine at Mount Sinai, New York, NY Indiana University Medical Center, Indianapolis, IN Physicians Skin Care, PLLC Louisville, KY DermResearch, PLLC, Louisville, KY Skin Sciences, PLLC, Louisville, KY
Optimizing combinations for psoriasis means asking patients to take control of their disease. It means balancing potency of steroids for the short-run to put out the fire and bring relief and maintaining the clearance for the long-run to reduce recurrence potential. Successful combinations are built on tolerability, ease of application, and the efficacy demonstrated by the synergy of the sum of the parts over being used separately.
J Drugs Dermatol. 2018;17(3):342-346.
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Extensive research has been published on the utility of topical steroids, derivatives of calcitriol including calcipotriene, and their roles in combination regimens for treating psoriasis. The effects on inflammation, differentiation, and mitigation of symptoms have given rise to several combination regimens as well as products containing both ingredients in one vehicle.1 The delivery to the scalp and other surface areas has represented a major challenge for both patients and clinicians, prompting support for the use of novel vehicles such as foams. As monotherapy, calcipotriene 0.005% foam demonstrated promising efficacy, safety, and tolerability when studied against its vehicle alone when applied twice daily for eight weeks.2 A controlled trial involving foams in combination to treat any surface area has to date not been published, although both steroid foams and calcipotriene foam have all been used extensively in clinical practice in various regimens. This report summarizes a single center study involving 57 patients, comparing the combination approach using an emollient foam preparation of clobetasol 0.05% emulsion foam (Olux E foam) and calcipotriene 0.005% foam (calcipotriene foam) to maintain treatment response in subjects with moderate plaque psoriasis on various body surface areas.Trial DesignAn investigator-initiated study was designed to compare the efficacy of maintenance effect for calcipotriene 0.005% foam twice a day either as monotherapy or with the addition of clobetasol 0.05% emollient foam bid on weekends, and with a vehicle arm for control. All subjects were scheduled for interim assessments at week 6 and for end of treatment visits at week 10. Each subject was responsible for completing subject grading assessments (SGA) and daily quality of life questionnaires (DLQI) as well. Of note, only the investigator was blinded to the test articles used by each subject during the trial.Subjects were sought that were over 18 years of age with anywhere from 3-10% BSA of moderate psoriasis plaques by IGA. All topical psoriasis therapies were washed out for two weeks, biologic agents for 3 months, and no subject was enrolled with a history of renal disease or condition involving hypercalcemiaPatients applied clobetasol emulsion foam twice a day for two weeks. Those who were clear or almost clear on PGA scale were rolled on to maintenance phase. Maintenance phase had three arms; Vehicle foam twice a day, calcipotriene foam twice a day, calcipotriene foam twice a day on week days and clobetasol emulsion foam twice a day on weekends for 8 weeks. Those subjects who ranked PGA scores of 2 or more (mild or more) were considered screen failures and were discontinued from the study. Additionally, a target lesion was chosen and evaluated for erythema, induration and scaling on a 0 to 8 scale. Each subject was responsible for completing subject grading assessments (SGA) and daily quality of life questionnaires (DLQI) as well. Subjects also answered a patient preference questionnaire in reference to the vehicles they have used.