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

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.

Study Overview

• Status: Completed
• Conditions: Plantar Warts; Common Warts
• Intervention / Treatment: Device: salicylic acid wart patches

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Lesser Poland Voivodeship
    • Miechów, Lesser Poland Voivodeship, Poland, 32-200
      • Dr Kowalska Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: patients treated with wart patches

Device: salicylic acid wart patches; The wart patches contain the auxiliary therapeutic substance salicylic acid at a concentration of 40%, which causes chemical exfoliation, removing the exfoliated skin. Salicylic acid softens the keratinised skin, making it easier to remove. The remedial process leads to the removal of the wart by exfoliation. The wart should disappear after about 7 days of using the patch. The treatment can be prolonged up to 21 days. The wart patch is intended for the treatment of common warts and plantar warts. The mechanism of action of the product is the barrier and protective action of the patch, reducing the possibility of spreading viral infection and, as an auxiliary, to exfoliate keratinised epidermis, accelerating the skin renewal process.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
reduction in the size of the lesion	reduction in the size of the lesion assessed by measuring with a dermatoscope	30 minutes (single visit)
change in the number of warts in the area of the main wart-like lesion	change in the number of warts in the area of the main wart-like lesion as assessed by the dermatologist	30 minutes (single visit)
occurrence of further dermal wart-like lesions in the treated area	occurrence of further dermal wart-like lesions in the treated area as assessed by the dermatologist	30 minutes (single visit)
Adverse events	Adverse events occuring during treatment of warts	30 minutes (single visit)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
reduction in lesion size	reduction in lesion size according to users' visual assessment	30 minutes (single visit)
reduction in the visibility of the lesion	reduction in the visibility of the lesion, user's visual assessment	30 minutes (single visit)
usability of the device	usability assessed with a questionaire	30 minutes (single visit)

Collaborators and Investigators

• Sponsor: Langsteiner sp. z o.o.

Study record dates

Study Major Dates

• Study Start (Actual): May 19, 2025
• Primary Completion (Actual): July 30, 2025
• Study Completion (Actual): September 5, 2025

Study Registration Dates

• First Submitted: April 25, 2025
• First Submitted That Met QC Criteria: April 25, 2025
• First Posted (Actual): May 6, 2025

Study Record Updates

• Last Update Posted (Estimated): September 8, 2025
• Last Update Submitted That Met QC Criteria: September 5, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Virus Diseases; DNA Virus Infections; Skin Diseases; Skin Diseases, Infectious; Tumor Virus Infections; Skin Diseases, Viral; Papillomavirus Infections; Skin and Connective Tissue Diseases; Warts; Anti-Infective Agents; Antifungal Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Inflammatory Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Antirheumatic Agents; Dermatologic Agents; Sensory System Agents; Analgesics, Non-Narcotic; Analgesics; Anti-Inflammatory Agents, Non-Steroidal; Cyclooxygenase Inhibitors; Keratolytic Agents; Salicylic Acid; Salicylates
• Other Study ID Numbers: 1.1.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No