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

March 18, 2024 updated by: Mahidol University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
    • Bangkok
      • Bangkok Noi, Bangkok, Thailand, 10700
        • Department of Dermatology, Siriraj Hospital Mahidol University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: EndWarts® FREEZE in Soft keratin
EndWarts® FREEZE were treated to 11 patients with wart at soft keratin
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.
Active Comparator: EndWarts® FREEZE in Hard keratin
EndWarts® FREEZE were treated to 11 patients with wart at hard keratin
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.
Active Comparator: Liquid nitrogen in Soft keratin
Liquid nitrogen were treated to 11 patients with wart at soft keratin
Device: Liquid nitrogen
Liquid nitrogen is a conventional cryotherapy treatment for cutaneous wart performed by physician at the hospital.
Other Names:
  • conventional cryotherapy
Active Comparator: Liquid nitrogen in Hard keratin
Liquid nitrogen were treated to 11 patients with wart at hard keratin
Device: Liquid nitrogen
Liquid nitrogen is a conventional cryotherapy treatment for cutaneous wart performed by physician at the hospital.
Other Names:
  • conventional cryotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cost-effectiveness of EndWarts® FREEZE
Time Frame: 12 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compared Dermatology quality of life index before and after treatment
Time Frame: 12 weeks
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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient satisfaction of EndWarts® FREEZE
Time Frame: 12 weeks
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
Compared side effect after treatment
Time Frame: 12 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mahidol University

Investigators

  • Principal Investigator: Charussri Leeyaphan, Assoc. Prof., Department of Dermatology Faculty of Medicine, Siriraj Hospital Mahidol University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 12, 2020

Primary Completion (Actual)

January 14, 2022

Study Completion (Actual)

January 14, 2022

Study Registration Dates

First Submitted

February 25, 2021

First Submitted That Met QC Criteria

March 1, 2021

First Posted (Actual)

March 4, 2021

Study Record Updates

Last Update Posted (Actual)

March 19, 2024

Last Update Submitted That Met QC Criteria

March 18, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EndWart

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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