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NCT06958237Completed

Salicylic Acid Wart Patch for the Treatment of Common Warts and Plantar Warts

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

Source: ClinicalTrials.gov · Last updated 8 Sept 2025

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
30 (actual)
First submitted
25 Apr 2025
Start date
19 May 2025
Primary completion date
30 Jul 2025
Lead sponsor
Langsteiner sp. z o.o.
NCT number
NCT06958237

What you commit to

  • Study type: Interventional
  • Participants enrolled: 30
  • From 19 May 2025 to the primary completion date, 30 Jul 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • failure to meet at least 1 inclusion criterion;
  • the patient has a known hypersensitivity to salicylic acid, salicylates or any other component of the patch;
  • patients with renal impairment (renal failure);
  • patients with skin conditions (e.g. inflammation, wounds, eczema) at the site of application,

Other

  • patients concurrently using other topical treatments in the area of the wart,
  • diabetic patients.

Who the study is looking for

  • giving consent to participate in the clinical trial (consent of the minor's guardian where applicable);
  • presence of at least 1 wart (common/plantar) on the body, with a lesion up to 1 cm in diameter;
  • age, at least 6 years.

Age in the registry: 6 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Dr Kowalska Clinic
Coordinator of this site? Confirm its status
MiechówPolandUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.