Common WartsNCT06958237
Salicylic Acid Wart Patch for the Treatment of Common Warts and Plantar Warts
A study testing salicylic acid wart patches in people with Common Warts and Plantar Warts, run by Langsteiner sp. z o.o. at 1 site in Poland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Common Warts, Plantar Warts
- What is being tested?
- salicylic acid wart patches
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePoland
- Study dates
- 19 May 2025to 5 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Common Warts, Plantar Warts
- Being tested
- salicylic acid wart patches
- Medical subject headings
- Warts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
salicylic acid wart patchesDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| patients treated with wart patches | Experimental | Not described Receives: Device: salicylic acid wart patches |
What is being measured
The primary outcome is the main question the study is designed to answer.
reduction in the size of the lesion
reduction in the size of the lesion assessed by measuring with a dermatoscope
Measured: 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
Measured: 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
Measured: 30 minutes (single visit)
Adverse events
Adverse events occuring during treatment of warts
Measured: 30 minutes (single visit)
Secondary outcomes (3)
reduction in lesion size
reduction in lesion size according to users' visual assessment
Measured: 30 minutes (single visit)
reduction in the visibility of the lesion
reduction in the visibility of the lesion, user's visual assessment
Measured: 30 minutes (single visit)
usability of the device
usability assessed with a questionaire
Measured: 30 minutes (single visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2025
- Study start19 May 2025
- Primary completion30 Jul 2025
- Study completion5 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Common WartsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Langsteiner sp. z o.o.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06958237
- Sponsor's protocol ID
- 1.1.
- Status last verified
- May 2025
- First submitted
- 25 Apr 2025
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Performance and Safety of the Medical Device: Salicylic Acid Wart Patch for the Treatment of Common Warts and Plantar Warts
- ClinicalTrials.gov ID
- NCT06958237
- Acronym / sponsor ID
- 1.1.
- Conditions
- Common Warts, Plantar Warts
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Langsteiner sp. z o.o.Industry (pharma, biotech, devices)
- Study start
- 19 May 2025 (actual)
- Primary completion
- 30 Jul 2025 (actual)
- Study completion
- 5 Sep 2025 (actual)
- First posted
- 6 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients treated with wart patches | Experimental | Device: salicylic acid wart patches |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| salicylic acid wart patchesThe 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. | Device | patients treated with wart patches |
Primary outcome
reduction in the size of the lesion
Time frame: 30 minutes (single visit)
reduction in the size of the lesion assessed by measuring with a dermatoscope
change in the number of warts in the area of the main wart-like lesion
Time frame: 30 minutes (single visit)
change in the number of warts in the area of the main wart-like lesion as assessed by the dermatologist
occurrence of further dermal wart-like lesions in the treated area
Time frame: 30 minutes (single visit)
occurrence of further dermal wart-like lesions in the treated area as assessed by the dermatologist
Adverse events
Time frame: 30 minutes (single visit)
Adverse events occuring during treatment of warts
3 secondary outcomes
reduction in lesion size
Time frame: 30 minutes (single visit)
reduction in the visibility of the lesion
Time frame: 30 minutes (single visit)
usability of the device
Time frame: 30 minutes (single visit)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing salicylic acid wart patches in people with Common Warts and Plantar Warts, run by Langsteiner sp. z o.o. at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
reduction in the size of the lesion (time frame: 30 minutes (single visit)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2025.