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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05617950
Other study ID # 306PLA-005
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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