Zakka Bajjani Jérôme, Auzou Pascale, Paniez Hubert, Katsogiannou Maria, Chapalain Véronique, Pierre Carole, Wiederkehr Sandra, Gauchoux Rémi, Gauthier Matthieu, Artus-Arduise Cécile
Laboratoire HRA Pharma, A Perrigo company, Chatillon, France.
ICTA PM, Fontaine les Dijon, France.
Med Devices (Auckl). 2025 Mar 27;18:213-231. doi: 10.2147/MDER.S501122. eCollection 2025.
Pathologic hyperkeratosis due to skin thickness increase includes corn, callous, and bunion. These conditions can cause important pain and discomfort. Treatment relies on eliminating the cause of friction and/or rubbing. Moreover, hydrocolloid occlusive dressings rehydrate hard skin, leading to maceration, facilitating removal of dead skin. Our goal was to further confirm real-life clinical performance and benefits of COMPEED Foot Care plasters in providing pain/discomfort relief, protection and cushioning of corns, calluses and bunions.
This was a non-interventional, longitudinal, multi-center investigation, conducted from July 2021 until February 2022, during which participants were enrolled in 36 community pharmacies in France. Eligible participants were ≥18 years old at enrolment, presented painful corn, callous and/or bunion on at least one foot, accepted to buy from the participating pharmacist at least one box of targeted COMPEED Foot Care plasters, to be used according to their instructions for use.
Overall, 417 participants gave their consent to participate in the study, and analysis was performed on 391 participants: 199 with corn, 106 with callous, 87 with bunion, whose median age was, respectively, 55.0, 59.0 and 55.0 years old (overall ranging 20.0 to 94.0 years old). Among participants with either of the 3 conditions, 21.7-37.9% reported instant pain/discomfort relief upon plaster application and an increasing number of participants with corns, calluses or bunions reported pain/discomfort elimination over the 21-days follow-up period. Significant increases in pressure relief and cushioning were also observed during follow-up in all 3 conditions. Median duration of plasters was 3 days. At study end, 66.0% of participants with calluses and up to 73.0% with corns reported their condition was removed.
This investigation demonstrated and confirmed COMPEED Foot Care plasters clinical benefits in pain/discomfort and pressure relief, cushioning against rubbing/friction of corns, calluses and bunions, and adhesion to skin, in the general population.
因皮肤增厚导致的病理性角化过度包括鸡眼、胼胝和拇囊炎。这些病症会引起严重的疼痛和不适。治疗方法是消除摩擦和/或挤压的原因。此外,水胶体封闭敷料可使硬皮重新水化,导致浸软,便于去除死皮。我们的目标是进一步证实COMPEED足部护理贴在缓解鸡眼、胼胝和拇囊炎的疼痛/不适、提供保护和缓冲方面的实际临床效果和益处。
这是一项非干预性、纵向、多中心研究,于2021年7月至2022年2月进行,期间参与者在法国的36家社区药店登记入组。符合条件的参与者入组时年龄≥18岁,至少一只脚上有疼痛的鸡眼、胼胝和/或拇囊炎,同意从参与研究的药剂师处购买至少一盒靶向COMPEED足部护理贴,并按其使用说明使用。
总体而言,417名参与者同意参与研究,对391名参与者进行了分析:199名有鸡眼,106名有胼胝,87名有拇囊炎,他们的中位年龄分别为55.0岁、59.0岁和55.0岁(总体年龄范围为20.0至94.0岁)。在患有这三种病症之一的参与者中,21.7%-37.9%的人报告贴上贴片后立即缓解了疼痛/不适,并且在21天的随访期内,越来越多患有鸡眼、胼胝或拇囊炎的参与者报告疼痛/不适消失。在所有三种病症的随访期间,还观察到压力缓解和缓冲能力显著增强。贴片的中位使用时长为3天。在研究结束时,66.0%患有胼胝的参与者和高达73.0%患有鸡眼的参与者报告其病症已消除。
本研究证明并确认了COMPEED足部护理贴在缓解疼痛/不适和压力、缓冲鸡眼、胼胝和拇囊炎的摩擦/挤压以及与皮肤的粘附方面对普通人群的临床益处。