Plain Language SummaryWhat is this summary about?While there are topical treatments available for managing atopic dermatitis (AD), the most common form of eczema, their use is constrained for reasons including restrictions on long-term application and/or skin irritation at the application site. Because of these concerns, researchers are investigating better ways to treat AD. After once-daily application for 4 weeks, a novel treatment, roflumilast cream, improved the appearance and symptoms of AD more than vehicle cream (cream that looked and felt like roflumilast cream but did not contain medicine) in two clinical studies (INTEGUMENT-1 and INTEGUMENT-2). Researchers wanted to learn more about long-term therapy with roflumilast cream; therefore, patients 6 years of age or older with AD who completed INTEGUMENT-1 or INTEGUMENT-2 could volunteer for the INTEGUMENT-OLE study. This article summarizes published results from INTEGUMENT-OLE, a study designed to determine if longer-term treatment with roflumilast cream had side effects and/or continued to improve AD.What are the key takeaways?Patients applied roflumilast cream once daily for up to 52 weeks. When a study clinician saw that AD was clear (no active AD), the patient was switched to twice-weekly application in areas where AD was previously being treated. Most patients did not have side effects while using roflumilast cream. AD signs and symptoms were reduced and/or improved over time. For patients with no active AD who switched to twice-weekly application, signs and symptoms of AD remained clear or almost clear for a median (mid-point of a set of values) duration of 281 days (9 months).What were the main conclusions reported by the researchers?Long-term treatment with roflumilast cream 0.15% was well tolerated by patients and also improved the appearance and symptoms of AD. These results support roflumilast cream 0.15% as an appropriate therapeutic option for mild-to-moderate AD, potentially reducing the need for treatments that contain steroids.How to say…Roflumilast: roh-FLOO-muh-lastEczema: EG-zuh-MUHInflammation: in-flah-MAY-shunAtopic dermatitis: ey-TOP-ik dur-muh-TAHY-tisPhosphodiesterase: faas-fow-dai-es-ter-aysVehicle: A cream that does not contain medicine but looks and feels the same as one that contains medicine; a vehicle is used in clinical studies of topical treatment so that those involved (including patients, health care professionals, and the sponsor) do not know who is receiving which treatment (until after the trial is over), so that results are not biased.OLE: ‘Open-label extension’; this is study that typically continues or ‘extends’ a previous clinical trial. In an OLE, all volunteers receive the active medicine being studied and know what treatment they are receiving.Clinical trial: A scientific investigation conducted to learn how well a treatment for a specific disease or condition works, and whether it raises any safety concerns; each trial has a special registration number (see ClinicalTrials.gov for more information).This is an abstract of the Plain Language Summary of Publication article.View the full Plain Language Summary PDF of this article to read the full-textLink to original article here
Simpson et al. (Thu,) studied this question.
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