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

Not Applicable

Not yet recruiting

• Conditions: Warts
• Interventions: Other: salicylic acid; Other: cryotherapy

• Registration Number: NCT05617950
• Lead Sponsor: The 306 Hospital of People's Liberation Army

Brief Summary

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 Timeline

• Status Verified: 2022-11
• Study Start: 2022-11
• Primary Completion: 2022-11
• Study Completion: 2022-11
• Study First Submitted: 2022-11-01
• Study First Submitted QC: 2022-11-08
• Last Update Submitted: 2022-11-08
• Study First Posted: 2022-11-16
• Last Update Posted: 2022-11-16

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 174

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
salicylic acid	salicylic acid	30% salicylic acid
cryotherapy	cryotherapy	liquid nitrogen

Primary Outcome Measures

Name	Time	Method
cure rate at 12 weeks	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.

Secondary Outcome Measures

Name	Time	Method
time to clearance of warts	12 weeks since the initial treatment	The time from treatment initiation until clearance of all warts
patient satisfaction with the treatment	12 weeks since the initial treatment	Patient satisfaction was rated on a 5-point scale (from very happy to very unhappy)
treatment-related adverse events	12 weeks since the initial treatment	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