Acta Dermato-Venereologica 99-10CompleteContent | Page 8

858 CLINICAL REPORT Clinical Efficacy of Oligofructans from Ophiopogon japonicus in Reducing Atopic Dermatitis Flare-ups in Caucasian Patients Carine MAINZER 1 , Maud LE GUILLOU 2 , Raoul VYUMVUHORE 2 , Bernard CHADOUTAUD 3 , Sylvie BORDES 2 and Brigitte CLOSS 2 SILAB Inc., East Brunswick, NJ, USA, 2 SILAB, R&D Department, Brive, and 3 Clinreal Online, Toulouse, France 1 Atopic dermatitis is a chronic relapsing inflammato- ry skin disease that affects 15–20% of children and 2–10% of adults worldwide. Topical treatments in- clude corticosteroids and calcineurin inhibitors, de- spite frequently observed adverse events, such as skin atrophy, itching and burning sensations. Alternative treatments that can prolong disease relief between flare-ups are therefore needed. A randomized, single- blind, placebo-controlled, multicentre clinical trial was conducted in a cohort of 90 Caucasian children and 144 adults with mild-to-moderate atopic dermatitis. Tested products were applied twice daily for 60 days. A natural active ingredient from Ophiopogon japonicus, which improves atopic dermatitis symptoms in vivo, was successful in reducing SCORing of Atopic Derma- titis (SCORAD), including erythema, pruritus and body surface area, in both cohorts. The active ingredient also improved patient’s quality of life and significantly reduced the number of patients relapsing compared with placebo. In conclusion, this treatment could be effective to help control mild-to-moderate atopic der- matitis between flare-ups. Key words: atopic dermatitis; SCORAD; quality of life; relief; Ophiopogon japonicus; clinical trial; oligofructans. Accepted May 22, 2019; E-published May 23, 2019 Acta Derm Venereol 2019; 99: 858–864. Corr: Carine Mainzer, SILAB Inc., One Tower Center Boulevard, Suite 2203, East Brunswick, NJ 08816, USA. Email: [email protected] A topic dermatitis (AD) is a common skin inflam- matory disease that affects 15–20% of children and 2–10% of adults in industrialized countries worldwide. AD can occur at different stages of life, but is mostly prevalent in children before the age of 6 years (1–3). AD is characterized by a breach in the skin barrier, which is weaker in individuals with AD due to lack of essential structural components (stratum corneum lipids and structural proteins), along with a heterogeneous im- mune response that can vary from type-1 to type-2/17/22 depending on the subtype of the disease (4, 5). Genetic predispositions (loss-of-function variants in the FLG gene), endogenous factors (e.g. psychological stress) and exogenous factors (e.g. pollution, allergens and irritants, hygiene practices) can trigger AD (6–9). Clinically, AD is identified by the presence of erythe- ma, oedema/papulation, oozing and crusting, excoriation, lichenification, and skin dryness, along with pruritus and doi: 10.2340/00015555-3224 Acta Derm Venereol 2019; 99: 858–864 SIGNIFICANCE Atopic dermatitis is a common inflammatory skin disease that affects both children and adults worldwide. Topical corticosteroids are regularly used to treat these patients, despite frequently observed adverse events. Alternative treat­ments that can prolong disease relief between flare- ups are therefore needed. This study found that oligofruc- tans derived from Ophiopogon japonicus improved atopic symptoms and patient’s quality of life, and restored skin barrier components known to be reduced in this disease. This active ingredient could be used together with a moistu- rizing treatment to prolong patients’ remission phase. sleep loss (10). These objective and subjective parame- ters define the SCORing of Atopic Dermatitis (SCO- RAD), which helps quantify the intensity and severity of this chronically relapsing disease. Moreover, AD can affect large body surface areas, especially in children, and thus greatly affects the quality of life (QoL) of both the patient and their family (11, 12). AD is often treated using topical corticosteroids (TCS) and topical calcineurin inhibitors (TCI), which help to reduce inflammation. However, these widely prescribed and effective treatments are often linked with adverse events, such as skin atrophy, striae and telangiectasia, systemic absorption (for TCS) or stinging and burning sensations (for TCI) (10, 13) and do not address repair of the skin barrier. Moisturizers are used to hydrate the skin with some proven efficacy in terms of barrier repair (14), but are not helpful enough to promote long-term relief. Herbal medicine, including plants derived from the Chinese tradition, is also widely used to treat AD, particularly among patients seeking natural alternative treatments (15). Herbal medicine, which contains blends of different herbs, have been shown to be effective in the treatment of oxidation, inflammation, allergy and microbes present in AD (15, 16), but must be used with care to avoid any adverse events (17). Ophiopogon japonicus, a plant used in traditional Chinese medicine (TCM) has been shown to correct the Th1/Th2 imbalance in mice models mimicking AD features (18), but has not been studied in humans. The aim of this study was to examine the effect of O. japonicus, which was processed to extract specific active molecules, identified as oligofructans (OF) (AD- RESYL ® , SILAB, Brive, France), on decreasing the frequency and intensity of AD flare-ups in Caucasian This is an open access article under the CC BY-NC license. www.medicaljournals.se/acta Journal Compilation © 2019 Acta Dermato-Venereologica.