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Trial Title:
Salicylic Acid Versus Cryotherapy for the Treatment of HPV1-induced Plantar Warts
NCT ID:
NCT05617950
Condition:
Warts
Conditions: Official terms:
Warts
Salicylic Acid
Salicylates
Study type:
Interventional
Study phase:
N/A
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Single (Outcomes Assessor)
Intervention:
Intervention type:
Other
Intervention name:
salicylic acid
Description:
Salicylic acid is applied once daily by the patients (or parents) for a maximum of 12
weeks.
Arm group label:
salicylic acid
Intervention type:
Other
Intervention name:
cryotherapy
Description:
Cryotherapy is delivered by a technician up to a maximum of four treatments 3 weeks
apart.
Arm group label:
cryotherapy
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.
Criteria for 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.
Gender:
All
Minimum age:
12 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
November 2022
Completion date:
November 2022
Lead sponsor:
Agency:
The 306 Hospital of People's Liberation Army
Agency class:
Other
Source:
The 306 Hospital of People's Liberation Army
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05617950
