Cost-effectiveness of EndWarts® FREEZE - an Alternative Home Cryotherapy Device for Wart Treatment
1 other identifier
interventional
22
1 country
1
Brief Summary
This study aimed to study cost-effectiveness of EndWarts® FREEZE for wart treatment, compared to conventional liquid nitrogen cryotherapy
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 12, 2020
CompletedFirst Submitted
Initial submission to the registry
February 25, 2021
CompletedFirst Posted
Study publicly available on registry
March 4, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 14, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
January 14, 2022
CompletedMarch 19, 2024
March 1, 2024
1.2 years
February 25, 2021
March 18, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Compared Dermatology quality of life index before and after treatment
12 weeks
Other Outcomes (2)
Patient satisfaction of EndWarts® FREEZE
12 weeks
Compared side effect after treatment
12 weeks
Study Arms (4)
EndWarts® FREEZE in Soft keratin
ACTIVE COMPARATOREndWarts® FREEZE were treated to 11 patients with wart at soft keratin
EndWarts® FREEZE in Hard keratin
ACTIVE COMPARATOREndWarts® FREEZE were treated to 11 patients with wart at hard keratin
Liquid nitrogen in Soft keratin
ACTIVE COMPARATORLiquid nitrogen were treated to 11 patients with wart at soft keratin
Liquid nitrogen in Hard keratin
ACTIVE COMPARATORLiquid nitrogen were treated to 11 patients with wart at hard keratin
Interventions
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 is a conventional cryotherapy treatment for cutaneous wart performed by physician at the hospital.
Eligibility Criteria
You may qualify if:
- Diagnosis of plantar or common wart at Department of Dermatology, Siriraj hospital
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Dermatology, Siriraj Hospital Mahidol University
Bangkok Noi, Bangkok, 10700, Thailand
Related Publications (5)
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.
PMID: 29214505RESULTGhadgepatil 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.
PMID: 27047542RESULTLipke MM. An armamentarium of wart treatments. Clin Med Res. 2006 Dec;4(4):273-93. doi: 10.3121/cmr.4.4.273.
PMID: 17210977RESULTSterling 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.
PMID: 25273231RESULTBruggink 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.
PMID: 20837684RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Charussri Leeyaphan, Assoc. Prof.
Department of Dermatology Faculty of Medicine, Siriraj Hospital Mahidol University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 25, 2021
First Posted
March 4, 2021
Study Start
November 12, 2020
Primary Completion
January 14, 2022
Study Completion
January 14, 2022
Last Updated
March 19, 2024
Record last verified: 2024-03
Data Sharing
- IPD Sharing
- Will not share