Cost-effectiveness of EndWarts® FREEZE - an Alternative Home Cryotherapy Device for Wart Treatment

Study Overview
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Brief Summary
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This study aimed to study cost-effectiveness of EndWarts® FREEZE for wart treatment, compared to conventional liquid nitrogen cryotherapy

Detailed Description
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Cutaneous warts, caused by Human papilloma virus (HPV), are common skin disease. The prevalence reported in primary school children are 2-20%, and even higher in adults. Non-intact skin are prone to the infection, with all parts of the body can be affected. Even warts are not malignant, they can cause lack of confidence or affected patients' quality of life. Nowadays there are many treatment methods for warts, such as topical application with salicylic acid and electrical cauterization. Cryotherapy with liquid nitrogen has been the therapy of choice due to its clinical effectiveness, which reported for 6-65%. Treatment mechanism in cryotherapy relies on in-depth freezing of infected keratocyte. EndWarts® FREEZE is alternative home treatment cryotherapy device containing nitrous oxide. Recent clinical study found that it delivers significant result with good tolerability, and is user friendly. As for our knowledge, no study has been reported about cost-effectiveness of this device, so this study was designed to demonstrate the efficacy of this product in cutaneous warts.

Official Title
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Cost-effectiveness of EndWarts® FREEZE for Wart Treatment: A Randomized, Controlled, Investigator-Blinded, Comparative Study

Conditions
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Cryotherapy Effect, Warts

Intervention / Treatment
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* Device: EndWarts® FREEZE
* Device: Liquid nitrogen


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of plantar or common wart at Department of Dermatology, Siriraj hospital Exclusion Criteria: Patient with more than 5 warts or wart more than 1 cm in diameter Wart at face, genitalia, scalp, joint Pregnancy or breastfeeding patient Wart with wound/irritation or local infection Diabetes mellitus patients or patients with coagulopathies or cryoglobulinemia Immunocompromised host or on immunosuppressive drug Received any treatment in previous 3 months before inclusion

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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Accepts Healthy Volunteers

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: EndWarts® FREEZE in Soft keratin<br>EndWarts® FREEZE were treated to 11 patients with wart at soft keratin | Device: EndWarts® FREEZE<br>* EndWarts® FREEZE is an alternative home cryotherapy device. Patients don't have to go to the hospital to receive treatment for their wart.<br>|
| Active Comparator: EndWarts® FREEZE in Hard keratin<br>EndWarts® FREEZE were treated to 11 patients with wart at hard keratin | Device: EndWarts® FREEZE<br>* EndWarts® FREEZE is an alternative home cryotherapy device. Patients don't have to go to the hospital to receive treatment for their wart.<br>|
| Active Comparator: Liquid nitrogen in Soft keratin<br>Liquid nitrogen were treated to 11 patients with wart at soft keratin | Device: Liquid nitrogen<br>* Liquid nitrogen is a conventional cryotherapy treatment for cutaneous wart performed by physician at the hospital.<br>* Other names: conventional cryotherapy;|
| Active Comparator: Liquid nitrogen in Hard keratin<br>Liquid nitrogen were treated to 11 patients with wart at hard keratin | Device: Liquid nitrogen<br>* Liquid nitrogen is a conventional cryotherapy treatment for cutaneous wart performed by physician at the hospital.<br>* Other names: conventional cryotherapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cost-effectiveness of EndWarts® FREEZE | Evaluate cost-effectiveness of EndWarts® FREEZE for wart treatment compared with conventional liquid nitrogen therapy. Transportation fee to the hospital, medical and doctor fee are recorded to sum up the costs of treatment at every visit. Every patient is also required to have his/her wart examined by the same physician at each visit with the use of dermoscope to evaluate the result of wart treatment (worse, the same, partial response, complete response). Moreover, wart size is measured for its diameter and height, then photographed at each visit to recorded the change after treatment. Cure rates will be shown according to type of intervention received, with the use of chi-square test. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compared Dermatology quality of life index before and after treatment | Compared patient's Dermatology quality of life index (DLQI) between treatment of EndWarts® FREEZE and liquid nitrogen. DLQI is recorded before the treatment start and after 12-week treatment (or before 12 week if the patient's wart is cured completely). Change in DLQI will be shown with descriptive statistics. | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cryotherapy effect, warts, treatment, EndWarts FREEZE