Biocompatibility and Post-Marketing Surveillance Study of Emollient Plus Medical Device Cream Containing Oligofructans from Ophiopogon japonicus and Acetyl Heptapeptide-4 in Atopic Dermatitis Skin Care

Abstract

Emollients plus are defined as topical formulations containing active ingredients with no pharmacological effect. They are designed to target multiple mechanisms in AD pathophysiology. The objective of the present study was to assess the efficacy of emollient plus medical device cream by performing a post-marketing surveillance study. It was carried out in cooperation with 88 members of the Polish Association for Atopic Diseases who were diagnosed with AD and voluntarily fulfilled the questionnaire after 14 days of product use. Additionally, the medical device underwent in vitro/ex vivo testing. Cytotoxicity was assessed by in vitro studies: direct MTT assay and indirect Agarose Overlay Assay. An ex vivo EpiDerm™ culture (EPI-200) was used to investigate the irritation potential, and culture medium was collected after 18 h of contact with the skin model to perform a flow cytometric for the analysis of inflammatory cytokines. A dermatological assessment with the local SCORAD was employed to confirm the efficacy of the cream. It was found that 86% of patients with AD observed an improvement in their skin condition during the two-week testing period. In vitro/ex vivo assays confirmed that the product is safe, non-irritant, and does not stimulate the production of proinflammatory cytokines. According to the local SCORAD, the symptoms of AD were alleviated. Moreover, preliminary studies indicated its efficacy in eliminating S. aureus on patients’ skin.