Evaluation of Performance and Safety of the Medical Device: Salicylic Acid Wart Patch for the Treatment of Common Warts and Plantar Warts

Common and plantar warts are a type of skin lesion caused by infection with the human papilloma virus. The incidence of warts is relatively high, with an estimated few to several per cent of the adult population affected. An even higher incidence of dermal warts is reported in the child and adolescent population, where it reaches nearly twenty per cent. The human papilloma virus (HPV) multiplies in the epidermal cells, leading to the formation of a skin lesion with a hyperkeratotic, uneven surface, called a wart. HPV infection can lead to various types of warts: including common warts, plantar warts, flat warts or condyloma acuminatum. Warts belong to skin lesions of a benign and self-limiting nature. Because of this, treatment of warts is often not applied. However, it is necessary to emphasise that warts, including in particular plantar warts, can be a source of pain as well as lead to psychological discomfort for the patient. Additionally, untreated warts are a potential source of subsequent infections.

For this reason, a variety of methods are used to treat warts, with the primary aim of removing the layer of diseased epidermis, as well as limiting the spread of the virus. The methods used to treat warts can be divided according to the nature of the agent used in the treatment - physical or chemical. Physical methods include cryotherapy, photodynamic therapy and surgical or laser wart removal. Chemical methods for the treatment of warts will be the use of ointments and solutions of substances such as salicylic acid, 5-fluorouracil, glycolic acid or purine acid. In addition, the treatment of warts also includes methods based on an occlusive action, involving the use of a barrier that shields the skin lesion and stops the spread of the virus.

This protocol concerns a study of salicylic acid wart patches. The aim of the study is to determine the efficacy and safety of their use in the treatment of common and plantar warts. The patches allow covering the lesion and the salicylic acid contained in them at a concentration of 40% has a keratolytic action allowing exfoliation of excessive epidermal proliferation caused by HPV infection. In addition, the mass of the product includes lanolin, which has an epidermal softening effect. The patches are intended for a patient population over six years of age, with common and plantar warts. The primary endpoints analysed in the study will be reduction in lesion size (assessed by dermatoscopic measurement), change in the number of warts in the area of the main wart-like lesion, occurrence of further dermal wart-like lesions in the treated area and incidence of adverse reactions. In addition, secondary endpoints to be analysed are reduction in lesion size (users' visual assessment), reduction in lesion visibility (users' visual assessment) and usability of the device.