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

NCT ID: NCT05617950

Last Updated: 2022-11-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 174 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-30
• Study Completion Date: 2022-11-30

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.

Conditions

Warts

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

salicylic acid

30% salicylic acid

Group Type: EXPERIMENTAL

salicylic acid

Intervention Type: OTHER

Salicylic acid is applied once daily by the patients (or parents) for a maximum of 12 weeks.

cryotherapy

liquid nitrogen

Group Type: ACTIVE_COMPARATOR

cryotherapy

Intervention Type: OTHER

Cryotherapy is delivered by a technician up to a maximum of four treatments 3 weeks apart.

Interventions

salicylic acid

Salicylic acid is applied once daily by the patients (or parents) for a maximum of 12 weeks.

Intervention Type: OTHER

cryotherapy

Cryotherapy is delivered by a technician up to a maximum of four treatments 3 weeks apart.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The 306 Hospital of People's Liberation Army

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shichao Lu, MD

Role: PRINCIPAL_INVESTIGATOR

The 306 Hospital of People's Liberation Army

Central Contacts

Shichao Lu, MD

Role: CONTACT

lvshichao@sina.com

8610-010-66356984

Other Identifiers

306PLA-005

Identifier Type: -

Identifier Source: org_study_id