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

Cryotherapy Effect Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04781244
• Other study ID #: EndWart
• Status: Completed
• Phase: N/A
• Start date: November 12, 2020
• Est. completion date: January 14, 2022

Study information

• Verified date: March 2024
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: January 14, 2022
• Est. primary completion date: January 14, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cryotherapy Effect
• Warts

Intervention

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

Locations

Country	Name	City	State
Thailand	Department of Dermatology, Siriraj Hospital Mahidol University	Bangkok Noi	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

References & Publications (5)

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. 2 — View 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. — View Citation

Lipke MM. An armamentarium of wart treatments. Clin Med Res. 2006 Dec;4(4):273-93. doi: 10.3121/cmr.4.4.273. — View 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 — View 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( — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient satisfaction of EndWarts® FREEZE	Compared patient satisfaction after treatment of EndWarts® FREEZE. Patient who received EndWarts® FREEZE treatment is required to answer the questionnaire after 12-week treatment (or before 12 week if the patient's wart is cured completely). The questionnaire included questions about the opinion of the product, such as effectiveness for wart treatment, portability, user-friendly, safety, and overall satisfaction. Score from each aspect of satisfaction will be calculated with descriptive statistics.	12 weeks
Other	Compared side effect after treatment	Compared side effect after treatment with EndWarts® FREEZE and liquid nitrogen. Every patient is required to record his/her side effects after each treatment, such as tingling sensation, burn or scar, hypo/hyperpigmentation, pain, pickling feeling, and report them to the physician at the next follow-up visit (Week 4, week 8, week 12). Number of patients with each side effect are recorded and described with descriptive statistics.	12 weeks
Primary	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	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