Efficacy of Laser Versus Cryotherapy in the Treatment of Warts

Study Overview
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Brief Summary
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The purpose of this study is to test the efficacy of laser versus cryotherapy on the treatment of warts

Detailed Description
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Cutaneous warts were a common skin diseases caused by human papilloma virus (HPV) infection. Although warts may spontaneously resolve, many patients seek for treatment for various reasons. There are many kinds of treatments for cutaneous warts, including salicylic acid, cryotherapy, laser, etc. A recent high quality RCT confirmed that the cure rate of topical salicylic acid and frozen has no difference at six months, but the efficacy of laser versus cryotherapy on the treatment of warts remains unclear. Therefore, we designed a randomized controlled trial to test the efficacy of laser versus cryotherapy on the treatment of warts.

Official Title
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Cryotherapy Versus Laser for the Treatment of Nongenital Cutaneous Warts: A Randomized Controlled Clinical Trial

Conditions
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Warts

Intervention / Treatment
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* Other: Cryotherapy
* Other: laser


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients have cutaneous warts, including common warts(d≥1cm or n≥5 ), plantar warts, periungual warts, mosaic warts, which are suitable for cryotherapy and laser treatment . patients aged eighting years and over, who have junior school degree or above Exclusion Criteria: Patients who have more than 20 warts Patients who are currently participating in another trial for the treatment of their warts Patients who took immunosuppressant drugs such as oral corticosteroids within the past three months. Patients who are pregnant or ready for pregnancies or breast-feeding. Patients who have impaired healing eg due to diabetes, vascular disease, vitamin A deficiency, hyperthyroidism and hypothyroidism. Patients who have autoimmune diseases, eg SLE, dermatomyositis, scleroderma and other diseases . Patients who have cold intolerance, eg cold urticaria, cryoglobulinaemia, cold agglutinin syndrome, Raynaud's syndrome. Patients who have local injections intolerance. Patients who have local hypoesthesia . Patients who can not tolerate cryotherapy or laser treatment for their own reasons.

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 |
| --- | --- |
| Active Comparator: Cryotherapy<br>Cryotherapy, at most 4 times | Other: Cryotherapy<br>* up to a maximum of four treatments every 21-28 days<br>|
| Experimental: laser<br>laser, at most 4 times | Other: laser<br>* up to a maximum of four treatments every 21-28 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cure rate | Warts was considered cured if they was no longer visible and could not be palpated anymore by hand. Assessment of whether or not cured was performed on site by a senior dermatologist | Cure rate will be calculated at 16 weeks and 6 months from the first treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| effective rate | Effective assessment is performed by a senior dermatologist. | Effective rate will be calculated at 16 weeks from the first treatment | 
| recurrence rate | A wart was considered recurrence if there are abnormalities or palpated foreign body in the original place. | Recurrence rate will be calculated at 12 months from the first treatment | 
| average cure days | Cure days was defined as the period from the first treatment until the date of clearance. | Average cure days will be calculated at 6 months from the first treatment | 
| side effects | including pain, swelling, blisters, blood blisters, bruising, bleeding,scarring, hypopigmentation, hyperpigmentation. | Side effects will be assessed within 3-4 weeks after each treatment | 
| pain intensity | on a scale of 0-10, where 0 is no pain and 10 is extremely painful | Pain intensity will be assessed within 3-4 weeks after each treatment | 
| patient satisfaction | on a five-point scale, from 'very satisfied' to 'very satisfied' | Patient satisfactionwill be assessed within 3-4 weeks after each treatment | 
| treatment costs | record the cost after each treatment | Treatment costs will be recorded within 10 minutes after each treatment | 
| relationship between HPV type and curative effect | take a small amount of cutaneous warts lesions and extract HPV DNA before treatment | Relationship between HPV type and curative effect will be analyzed at 16 weeks and 6 months from the first treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cryotherapy, laser, cutaneous warts