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

The 306 Hospital of People's Liberation Army174 enrolled

Overview

To evaluate whether salicylic acid was superior to cryotherapy for plantar warts

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

174

Conditions

Warts

Interventions

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.

Eligibility

Sex: ALLMin age: 12 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: 12 weeks since the initial treatment

Secondary Outcomes

time to clearance of warts

The time from treatment initiation until clearance of all warts

Time frame: 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)

Time frame: 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

Time frame: 12 weeks since the initial treatment

Central Contacts

Shichao Lu, MD

CONTACT

8610-010-66356984 lvshichao@sina.com

Data from ClinicalTrials.gov

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