Salicylic Acid Versus Cryotherapy for the Treatment of HPV1-induced Plantar Warts

Study Overview
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Brief Summary
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To evaluate whether salicylic acid was superior to cryotherapy for plantar warts

Detailed Description
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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.

Official Title
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Salicylic Acid Versus Cryotherapy for the Treatment of HPV1-induced Plantar Warts: a Randomized Controlled Trial

Conditions
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Warts

Intervention / Treatment
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* Other: salicylic acid
* Other: cryotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with HPV1-induced plantar warts. Total number of warts is ≤5. Aged 12 years or older. Exclusion Criteria: 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. 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.

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: salicylic acid<br>30% salicylic acid | Other: salicylic acid<br>* Salicylic acid is applied once daily by the patients (or parents) for a maximum of 12 weeks.<br>|
| Active Comparator: cryotherapy<br>liquid nitrogen | Other: cryotherapy<br>* Cryotherapy is delivered by a technician up to a maximum of four treatments 3 weeks apart.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 12 weeks since the initial treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time to clearance of warts | The time from treatment initiation until clearance of all warts | 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) | 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 | 12 weeks since the initial treatment |