Salicylic Acid Versus Cryotherapy for the Treatment of HPV1-induced Plantar Warts
Study Details
Study Description
Brief Summary
To evaluate whether salicylic acid was superior to cryotherapy for plantar warts
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: salicylic acid 30% salicylic acid |
Other: salicylic acid
Salicylic acid is applied once daily by the patients (or parents) for a maximum of 12 weeks.
|
| Active Comparator: cryotherapy liquid nitrogen |
Other: cryotherapy
Cryotherapy is delivered by a technician up to a maximum of four treatments 3 weeks apart.
|
Outcome Measures
Primary Outcome Measures
- 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
- 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
Eligibility Criteria
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.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- The 306 Hospital of People's Liberation Army
Investigators
- Principal Investigator: Shichao Lu, MD, The 306 Hospital of People's Liberation Army
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 306PLA-005