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

Warts Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05617950
• Other study ID #: 306PLA-005
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 2022
• Est. completion date: November 2022

Study information

• Verified date: November 2022
• Source: The 306 Hospital of People's Liberation Army
• Contact: Shichao Lu, MD
• Phone: 8610-010-66356984
• Email: lvshichao[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 174
• Est. completion date: November 2022
• Est. primary completion date: November 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Warts

Intervention

Other:
• salicylic acid
Salicylic acid is applied once daily by the patients (or parents) for a maximum of 12 weeks.
• cryotherapy
Cryotherapy is delivered by a technician up to a maximum of four treatments 3 weeks apart.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The 306 Hospital of People's Liberation Army

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	time to clearance of warts	The time from treatment initiation until clearance of all warts	12 weeks since the initial treatment
Secondary	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
Secondary	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