Clinical trial NCT04781244: Cost-effectiveness of EndWarts® FREEZE - an Alternative Home Cryotherapy Device for Wart Treatment
Official title: Cost-effectiveness of EndWarts® FREEZE for Wart Treatment: A Randomized, Controlled, Investigator-Blinded, Comparative Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cryotherapy Effect
Warts
Keywords: cryotherapy effect
warts
treatment
EndWarts FREEZE
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2021-03-04
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Cost-effectiveness of EndWarts® FREEZE
timeFrame: 12 weeks
Secondary outcomes:
measure: Compared Dermatology quality of life index before and after treatment
timeFrame: 12 weeks
Other outcomes:
measure: Patient satisfaction of EndWarts® FREEZE
timeFrame: 12 weeks
measure: Compared side effect after treatment
timeFrame: 12 weeks
Locations:
city: Bangkok Noi
country: Thailand
facility: Department of Dermatology, Siriraj Hospital Mahidol University
state: Bangkok
Study officials:
affiliation: Department of Dermatology Faculty of Medicine, Siriraj Hospital Mahidol University
name: Charussri Leeyaphan, Assoc. Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Walczuk I, Eertmans F, Rossel B, Cegielska A, Stockfleth E, Antunes A, Adriaens E. Efficacy and Safety of Three Cryotherapy Devices for Wart Treatment: A Randomized, Controlled, Investigator-Blinded, Comparative Study. Dermatol Ther (Heidelb). 2018 Jun;8(2):203-216. doi: 10.1007/s13555-017-0210-5. Epub 2017 Dec 6.
citation: Ghadgepatil SS, Gupta S, Sharma YK. Clinicoepidemiological Study of Different Types of Warts. Dermatol Res Pract. 2016;2016:7989817. doi: 10.1155/2016/7989817. Epub 2016 Mar 7.
citation: Lipke MM. An armamentarium of wart treatments. Clin Med Res. 2006 Dec;4(4):273-93. doi: 10.3121/cmr.4.4.273.
citation: Sterling JC, Gibbs S, Haque Hussain SS, Mohd Mustapa MF, Handfield-Jones SE. British Association of Dermatologists' guidelines for the management of cutaneous warts 2014. Br J Dermatol. 2014 Oct;171(4):696-712. doi: 10.1111/bjd.13310. Epub 2014 Oct 1. No abstract available.
citation: Bruggink SC, Gussekloo J, Berger MY, Zaaijer K, Assendelft WJ, de Waal MW, Bavinck JN, Koes BW, Eekhof JA. Cryotherapy with liquid nitrogen versus topical salicylic acid application for cutaneous warts in primary care: randomized controlled trial. CMAJ. 2010 Oct 19;182(15):1624-30. doi: 10.1503/cmaj.092194. Epub 2010 Sep 13.