Handling of Sore Noses: a Proof of Concept
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MEDICINE
Handling of Sore Noses: a Proof of Concept Nadine Wurzer-Materna 1 & Uta Thieme 2 & Dieter Werdier 3 & Peter Meiser 4 Accepted: 26 March 2020 / Published online: 21 April 2020 # The Author(s) 2020
Abstract Dryness and soreness of the anterior part of the nose frequently occur and hinder patients’ quality of life. Nasal ointments are broadly applied in such cases, bringing about at least subjective improvement of clinical signs and symptoms. The mode of action of such treatments is occlusion of the wounded skin parts, which is commonly already achieved by the ointment base. However, the clinical benefit of such treatments has yet to be proven. In this trial, 100 patients suffering from soreness of the anterior part of the nose were randomized to receive either an anhydrous nasal ointment or no local treatment. Area under the curve built from daily average scores of the symptoms sensation of dryness, soreness, scaliness, and pain, evaluated by the patients on a daily basis over a period of 9 days, was the predefined primary endpoint of this trial. Symptoms were furthermore assessed by the physicians, and patients allocated to the treatment group assessed their perceptions on the use of the nasal ointment on the initiation and the close-out visit. Clinical signs and symptoms improved significantly between the initial and close-out visits in both ointment and control groups. However, treatment with the nasal ointment proved to be significantly superior to no therapy. Both evaluation of patients’ perceptions of the treatment and tolerability assessment substantiate the safe and efficacious use of the tested nasal ointment. Keywords Nasal ointment . Rhinitis . Rhinitis sicca . Wound healing
Introduction Substance-based medical devices are considered “borderline” products with similar appearance and intended purpose as compared with medicinal products, but, by definition with a primarily non-pharmacologic mode of action. Classic examples are moistening nasal sprays or eye drops. Rising regulatory requirements, such as European Medical Device Regulation EU 2017/745 [1], entail efforts to provide stronger clinical evidence to support the safety and performance of the devices. We intended to substantiate the safety and performance of an established medical device nasal ointment that is used for the moistening and care of the anterior part of the This article is part of the Topical Collection on Medicine * Peter Meiser [email protected] 1
ENT praxis, Hofackerstraße 19, 86179 Augsburg, Germany
2
ENT praxis, Mercatorstraße 10-12, 47051 Duisburg, Germany
3
SAM GmbH, Tittardshang 5, 52072 Aachen, Germany
4
Ursapharm Arzneimittel GmbH, Industriestraße 35, 66129 Saarbrucken, Germany
nose in the case of rhinitis sicca anterior and for the treatment of soreness due to acute or chronic rhinosinusitis, thus conditions commonly occurring in clinical practice. The device acts simply by occlusion of the wounded skin parts, which is commonly already achieved by the ointment base. Thus, we were confronted with the chal
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