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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-12

Study Completion Date

2022-01-14

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

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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.

Conditions

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Cryotherapy Effect Warts

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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EndWarts® FREEZE in Soft keratin

EndWarts® FREEZE were treated to 11 patients with wart at soft keratin

Group Type ACTIVE_COMPARATOR

EndWarts® FREEZE

Intervention Type DEVICE

EndWarts® FREEZE is an alternative home cryotherapy device. Patients don't have to go to the hospital to receive treatment for their wart.

EndWarts® FREEZE in Hard keratin

EndWarts® FREEZE were treated to 11 patients with wart at hard keratin

Group Type ACTIVE_COMPARATOR

EndWarts® FREEZE

Intervention Type DEVICE

EndWarts® FREEZE is an alternative home cryotherapy device. Patients don't have to go to the hospital to receive treatment for their wart.

Liquid nitrogen in Soft keratin

Liquid nitrogen were treated to 11 patients with wart at soft keratin

Group Type ACTIVE_COMPARATOR

Liquid nitrogen

Intervention Type DEVICE

Liquid nitrogen is a conventional cryotherapy treatment for cutaneous wart performed by physician at the hospital.

Liquid nitrogen in Hard keratin

Liquid nitrogen were treated to 11 patients with wart at hard keratin

Group Type ACTIVE_COMPARATOR

Liquid nitrogen

Intervention Type DEVICE

Liquid nitrogen is a conventional cryotherapy treatment for cutaneous wart performed by physician at the hospital.

Interventions

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EndWarts® FREEZE

EndWarts® FREEZE is an alternative home cryotherapy device. Patients don't have to go to the hospital to receive treatment for their wart.

Intervention Type DEVICE

Liquid nitrogen

Liquid nitrogen is a conventional cryotherapy treatment for cutaneous wart performed by physician at the hospital.

Intervention Type DEVICE

Other Intervention Names

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conventional cryotherapy

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes