Acta Dermato-Venereologica 98-5CompleteContent | Page 13

517 CLINICAL REPORT Stand-alone Emollient Treatment Reduces Flares After Discontinuation of Topical Steroid Treatment in Atopic Dermatitis: A Double-blind, Randomized, Vehicle-controlled, Left-right Comparison Study Irena ANGELOVA-FISCHER 1 , Frank RIPPKE 2 , Daniel RICHTER 2 , Alexander FILBRY 2 , Craig ARROWITZ 3 , Teresa WEBER 3 , Tobias W. FISCHER 1 and Detlef ZILLIKENS 1 Department of Dermatology, University of Lübeck, 2 Research and Development, Beiersdorf AG, Hamburg, Germany, and 3 Research and Development, Beiersdorf Inc., Wilton, CT, USA 1 Prevention of the flares is a main goal in the long-term treat­ment of atopic dermatitis (AD). Therefore we in- vestigated the efficacy of a water-in-oil emollient, con- taining licochalcone A, omega-6-fatty acids, ceramide 3 and glycerol, for prevention of the flares in adults with mild to moderately severe AD, treated with topi- cal steroids, that led to clearing of the inflammatory lesions and had been discontinued prior to inclusion. The study was a 12-week, double-blind, randomized, vehicle-controlled, left-right comparison test with the number of relapses, defined as re-occurrence of eryt- hema for at least 3 consecutive days, considered the primary outcome. Compared with the vehicle, the ac- tive formulation significantly reduced the number of relapses and maintained the barrier homeostasis of the respective arm. To the best of knowledge, this is the first study to show prevention of the AD flares by the use of stand-alone emollient treatment, based on comparison with the corresponding vehicle while ex- cluding concomitant/rescue medications. the barrier function might be a safe and efficient strategy for disease prevention and reducing the risk of flares (13, 14). Although several investigations provide initial evidence for reduced risk and prolonged time to flare (15–20), the interpretation of the published results has been limited by lack of comparison with the respective vehicle controls or the concomitant use of topical pre­ scription medication, notably steroids and calcineurin inhibitors. As emollients are fundamental to the long- term disease management, the present double-blind, randomized, left–right comparison study investigated the effects of a water in oil (w/o) formulation on the rate of relapses, compared with the corresponding vehicle, while excluding possible confounders, such as conco- mitant use of anti-inflammatory or rescue medication. Key words: atopic dermatitis; maintenance treatment; emol- lients; skin barrier; licochalcone A; omega-6 fatty acids. The study was a double-blind, prospective, randomized, vehicle- controlled left-right comparison test of maximum 12 weeks duration. Eligible for participation were female and male volun- teers aged 18–65 years with AD according to the UK Working Party Criteria (21) and mild to moderately severe inflammatory lesions, located symmetrically on both forearms/arms within the last 4 weeks prior to inclusion, that had been treated with topical steroids (class I–III) and resolved completely, so that the topical steroids had been discontinued before entering the study (Fig. 1). The exclusion criteria were defined as follows: (i) manifest oedema, papules, exudation or crusts in the test area; (ii) erythema > 1 or/and excoriations > 2, based on SCORing Atopic Dermatitis (SCORAD) intensity parameters (local SCORAD); (iii) local SCORAD in the test area >5. Further exclusion criteria included clinical manifestations of another skin disease in the test area, treatment with immunosuppressive or antimicrobial agents and/ or ultraviolet (UV) light treatment in the last 2 weeks prior to Accepted Jan 15, 2018; Epub ahead of print Jan 16, 2018 Acta Derm Venereol 2018; 98: 517–523. Corr: Irena Angelova-Fischer, Department of Dermatology, University of Lübeck, Ratzeburger Allee 160, DE-23538 Lübeck, Germany. E-mail: [email protected] A topic dermatitis (AD), or eczema, is a chronic, relapsing and intensely pruritic inflammatory skin disease resulting from a complex interplay of host- related and environmental factors (1–4). The recurrent eczematous lesions with age-specific morphology and distribution usually occur for the first time in infancy or early childhood and may persist throughout life in up to 60% of the cases of moderate or severe childhood eczema (5). The management of AD relies on efficient control of the flares by treatment of the acute inflam- matory symptoms in parallel with identification and avoidance of the relevant triggering factors and main- tenance of the skin barrier homeostasis (6–9). With the recognition of the critical role of the epidermal barrier to disease pathogenesis and associated allergic co- morbidities (3, 10–12), recent studies have investigated whether emollient treatment that aims at restoration of MATERIALS AND METHODS Study design and population Baseline +12 wks Pre-study phase D-30/D-1 D0 D7 D28 Randomization (1:1) Initiation emolient/vehicle use Discontinuation of topical steroid use D56 D84 Dicontinuation emollient/vehicle use (study end) Fig. 1. Study outline. This is an open access article under the CC BY-NC license. www.medicaljournals.se/acta Journal Compilation © 2018 Acta Dermato-Venereologica. D14 doi: 10.2340/00015555-2882 Acta Derm Venereol 2018; 98: 517–523