Laser Versus Cryotherapy for the Treatment of Recalcitrant Warts

Study Overview
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Brief Summary
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To evaluate whether laser was superior to cryotherapy for recalcitrant warts

Detailed Description
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Patients with recalcitrant warts were randomized equally to receive laser or cryotherapy every 3 to 4 weeks, for a maximum of 4 sessions.The primary outcomes were the cure rate at 16 weeks; secondary outcomes included time to clearance of warts, patient satisfaction with the treatment and treatment-related adverse effects.

Official Title
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Laser Versus Cryotherapy for the Treatment of Recalcitrant Warts: a Randomised Controlled Trial

Conditions
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Warts

Intervention / Treatment
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* Other: laser treatment
* Other: cryotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with HPV2/27/57-induced recalcitrant warts, including periungualor mosaic warts, common or plantar warts with a duration of longer than 1 year, and common or plantar warts previously received no more than two sessions of cryotherapy Total number of warts is ≤10 . Aged 18 years or older. Exclusion Criteria: Patients are currently participating in another trial for the treatment of cutaneous warts. 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 laser or cryotherapy.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: laser treatment<br>LP-Nd:YAG laser treatment | Other: laser treatment<br>* a maximum of 4 sessions, with an interval of 3 to 4 weeks<br>|
| Active Comparator: cryotherapy<br>cryotherapy with liquid nitrogen | Other: cryotherapy<br>* a maximum of 4 sessions, with an interval of 3 to 4 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cure rate at 16 weeks | A patient was considered to be cured if all warts were no longer visible and could not be palpated anymore. | 16 weeks since the initial treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time to clearance of warts | The time from treatment initiation until clearance of all warts | 16 weeks since the initial treatment | 
| patient satisfaction with the treatment | Patient satisfaction was rated on a 5-point scale (from very happy to very unhappy) | 16 weeks since the initial treatment | 
| 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 | 16 weeks since the initial treatment |