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

Mahidol University

Status: Completed

Conditions: Cryotherapy Effect; Warts

Treatments: Device: EndWarts® FREEZE; Device: Liquid nitrogen

Study type: Interventional

Funder types: Other

Identifiers

NCT04781244

EndWart

Details and patient eligibility

About

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

Full description

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.

Enrollment: 22 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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22 participants in 4 patient groups

EndWarts® FREEZE in Soft keratin

Active Comparator group

Description:

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

Treatment:

Device: EndWarts® FREEZE

EndWarts® FREEZE in Hard keratin

Active Comparator group

Description:

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

Treatment:

Device: EndWarts® FREEZE

Liquid nitrogen in Soft keratin

Active Comparator group

Description:

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

Treatment:

Device: Liquid nitrogen

Liquid nitrogen in Hard keratin

Active Comparator group

Description:

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

Treatment:

Device: Liquid nitrogen