Back to resultsSalicylic Acid Versus Cryotherapy for the Treatment of HPV1-induced Plantar Warts
Primary Purpose
Warts
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
salicylic acid
cryotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Warts
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
salicylic acid
cryotherapy
Arm Description
30% salicylic acid
liquid nitrogen
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
time to clearance of warts
The time from treatment initiation until clearance of all warts
patient satisfaction with the treatment
Patient satisfaction was rated on a 5-point scale (from very happy to very unhappy)
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
Full Information
NCT ID
NCT05617950
First Posted
November 1, 2022
Last Updated
November 8, 2022
Sponsor
The 306 Hospital of People's Liberation Army
1. Study Identification
Unique Protocol Identification Number
NCT05617950
Brief Title
Salicylic Acid Versus Cryotherapy for the Treatment of HPV1-induced Plantar Warts
Official Title
Salicylic Acid Versus Cryotherapy for the Treatment of HPV1-induced Plantar Warts: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 2022 (Anticipated)
Primary Completion Date
November 2022 (Anticipated)
Study Completion Date
November 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The 306 Hospital of People's Liberation Army
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Warts
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
174 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
salicylic acid
Arm Type
Experimental
Arm Description
30% salicylic acid
Arm Title
cryotherapy
Arm Type
Active Comparator
Arm Description
liquid nitrogen
Intervention Type
Other
Intervention Name(s)
salicylic acid
Intervention Description
Salicylic acid is applied once daily by the patients (or parents) for a maximum of 12 weeks.
Intervention Type
Other
Intervention Name(s)
cryotherapy
Intervention Description
Cryotherapy is delivered by a technician up to a maximum of four treatments 3 weeks apart.
Primary Outcome Measure Information:
Title
cure rate at 12 weeks
Description
A patient was considered to be cured if all warts were no longer visible and could not be palpated anymore.
Time Frame
12 weeks since the initial treatment
Secondary Outcome Measure Information:
Title
time to clearance of warts
Description
The time from treatment initiation until clearance of all warts
Time Frame
12 weeks since the initial treatment
Title
patient satisfaction with the treatment
Description
Patient satisfaction was rated on a 5-point scale (from very happy to very unhappy)
Time Frame
12 weeks since the initial treatment
Title
treatment-related adverse events
Description
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
Time Frame
12 weeks since the initial treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shichao Lu, MD
Phone
8610-010-66356984
Email
lvshichao@sina.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shichao Lu, MD
Organizational Affiliation
The 306 Hospital of People's Liberation Army
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Salicylic Acid Versus Cryotherapy for the Treatment of HPV1-induced Plantar Warts
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