WartsNCT05617950
Salicylic Acid Versus Cryotherapy for the Treatment of HPV1-induced Plantar Warts
A study testing salicylic acid and cryotherapy in people with Warts, run by The 306 Hospital of People's Liberation Army.
Trial summary
To evaluate whether salicylic acid was superior to cryotherapy for plantar warts Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Warts
- What is being tested?
- salicylic acid and cryotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 174 participants
- Where
- No sites listed yet
- Study dates
- Nov 2022to Nov 2022
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with HPV1-induced plantar warts.
- Total number of warts is ≤5.
- Aged 12 years or older.
Who cannot join
- Patients are currently participating in another trial for the treatment of plantar warts.
- Patients had received two or more consecutive sessions of cryotherapy, with an interval of no more than 4 weeks (The history of salicylic acid treatment was not considered as criteria for exclusion because high concentration salicylic acid is not commercially available in Chinese mainland).
- Patients have taken immunosuppressant drugs (such as oral corticosteroids) during the past three months.
- Patients have impaired healing eg due to diabetes, vitamin A deficiency, hyperthyroidism and hypothyroidism.
- Patients have autoimmune diseases (such as systemic lupus erythematosus, dermatomyositis, scleroderma or other diseases).
- Patients are pregnant or ready for pregnancies or breast-feeding.
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- Patients have cold intolerance (such as cold urticaria, cryoglobulinaemia, cold agglutinin syndrome or Raynaud's syndrome).
- Patients have local pain intolerance.
- Patients have local hypoesthesia.
- Patients are unable to tolerate salicylic acid or cryotherapy.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Salicylic Acid Versus Cryotherapy for the Treatment of HPV1-induced Plantar Warts: a Randomized Controlled Trial
To evaluate whether salicylic acid was superior to cryotherapy for plantar warts
Read the detailed description
Patients with plantar warts were randomized equally to receive salicylic acid or cryotherapy. Cryotherapy is delivered by a technician up to a maximum of four treatments 3 weeks apart. Thirty percent of salicylic acid is applied once daily by the patient (or parent) for a maximum of 12 weeks. The primary outcomes were the cure rates at 12 weeks; secondary outcomes included time to clearance of warts, patient satisfaction with the treatment and treatment-related adverse effects.
- Conditions
- Warts
- Being tested
- salicylic acid, cryotherapy
- Medical subject headings
- Warts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
salicylic acidOther
Salicylic acid is applied once daily by the patients (or parents) for a maximum of 12 weeks.
cryotherapyOther
Cryotherapy is delivered by a technician up to a maximum of four treatments 3 weeks apart.
| Study group | Role | What they receive |
|---|---|---|
| salicylic acid | Experimental | 30% salicylic acid Receives: Other: salicylic acid |
| cryotherapy | Active comparator | liquid nitrogen Receives: Other: cryotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
cure rate at 12 weeks
A patient was considered to be cured if all warts were no longer visible and could not be palpated anymore.
Measured: 12 weeks since the initial treatment
Secondary outcomes (3)
time to clearance of warts
The time from treatment initiation until clearance of all warts
Measured: 12 weeks since the initial treatment
patient satisfaction with the treatment
Patient satisfaction was rated on a 5-point scale (from very happy to very unhappy)
Measured: 12 weeks since the initial treatment
treatment-related adverse events
Some adverse effects, including pain, swelling, blisters, hemorrhagic bullae, bruising, and skin breakdown, were recorded by the patients, whereas others, including secondary bacterial infection, hyperpigmentation, hypopigmentation, and scarring were evaluated by a dermatologist
Measured: 12 weeks since the initial treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2022
- Study startNov 2022 (estimated)
- Primary completionNov 2022 (estimated)
- Study completionNov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 174 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The 306 Hospital of People's Liberation Army
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shichao Lu, MD, Principal investigator, The 306 Hospital of People's Liberation Army
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05617950
- Sponsor's protocol ID
- 306PLA-005
- Status last verified
- Nov 2022
- First submitted
- 1 Nov 2022
- Last updated
- 16 Nov 2022
- 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 16 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Salicylic Acid Versus Cryotherapy for the Treatment of HPV1-induced Plantar Warts: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05617950
- Acronym / sponsor ID
- 306PLA-005
- Conditions
- Warts
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 174 participants (estimated)
- Lead sponsor
- The 306 Hospital of People's Liberation ArmyUniversity, hospital or other
- Study start
- Nov 2022 (estimated)
- Primary completion
- Nov 2022 (estimated)
- Study completion
- Nov 2022 (estimated)
- First posted
- 16 Nov 2022 (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.
To evaluate whether salicylic acid was superior to cryotherapy for plantar warts
Detailed description
Patients with plantar warts were randomized equally to receive salicylic acid or cryotherapy. Cryotherapy is delivered by a technician up to a maximum of four treatments 3 weeks apart. Thirty percent of salicylic acid is applied once daily by the patient (or parent) for a maximum of 12 weeks. The primary outcomes were the cure rates at 12 weeks; secondary outcomes included time to clearance of warts, patient satisfaction with the treatment and treatment-related adverse effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| salicylic acid | Experimental | Other: salicylic acid30% salicylic acid |
| cryotherapy | Active comparator | Other: cryotherapyliquid nitrogen |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with HPV1-induced plantar warts.
- Total number of warts is ≤5.
- Aged 12 years or older.
Key exclusion criteria (10 listed)
- Patients are currently participating in another trial for the treatment of plantar warts.
- Patients had received two or more consecutive sessions of cryotherapy, with an interval of no more than 4 weeks (The history of salicylic acid treatment was not considered as criteria for exclusion because high concentration salicylic acid is not commercially available in Chinese mainland).
- Patients have taken immunosuppressant drugs (such as oral corticosteroids) during the past three months.
- Patients have impaired healing eg due to diabetes, vitamin A deficiency, hyperthyroidism and hypothyroidism.
- Patients have autoimmune diseases (such as systemic lupus erythematosus, dermatomyositis, scleroderma or other diseases).
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 acidSalicylic acid is applied once daily by the patients (or parents) for a maximum of 12 weeks. | Other | salicylic acid |
| cryotherapyCryotherapy is delivered by a technician up to a maximum of four treatments 3 weeks apart. | Other | cryotherapy |
Primary outcome
cure rate at 12 weeks
Time frame: 12 weeks since the initial treatment
A patient was considered to be cured if all warts were no longer visible and could not be palpated anymore.
3 secondary outcomes
time to clearance of warts
Time frame: 12 weeks since the initial treatment
patient satisfaction with the treatment
Time frame: 12 weeks since the initial treatment
treatment-related adverse events
Time frame: 12 weeks since the initial treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2022.
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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.
Shichao Lu, MD principal investigator
The 306 Hospital of People's Liberation Army
Questions about this trial
What is this clinical trial studying?
A study testing salicylic acid and cryotherapy in people with Warts, run by The 306 Hospital of People's Liberation Army.
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 10 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: status not confirmed, as of the sponsor's last update on 16 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shichao Lu, MD (8610-010-66356984, lvshichao@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cure rate at 12 weeks (time frame: 12 weeks since the initial treatment). 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 16 Nov 2022; AzTrials last refreshed its copy on 8 Nov 2026.