Cryotherapy EffectNCT04781244
Cost-effectiveness of EndWarts® FREEZE - an Alternative Home Cryotherapy Device for Wart Treatment
A study testing EndWarts® FREEZE and Liquid nitrogen in people with Cryotherapy Effect and Warts, run by Mahidol University at 1 site in Thailand.
Trial summary
This study aimed to study cost-effectiveness of EndWarts® FREEZE for wart treatment, compared to conventional liquid nitrogen cryotherapy Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cryotherapy Effect, Warts
- What is being tested?
- EndWarts® FREEZE and Liquid nitrogen
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteThailand
- Study dates
- 12 Nov 2020to 14 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Diagnosis of plantar or common wart at Department of Dermatology, Siriraj hospital
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Thailand1 site
Department of Dermatology, Siriraj Hospital Mahidol University
Bangkok Noi, Bangkok, 10700
About this study
Official title: 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
Read the 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.
- Conditions
- Cryotherapy Effect, Warts
- Being tested
- EndWarts® FREEZE, Liquid nitrogen
- Keywords
- cryotherapy effect, warts, treatment, EndWarts FREEZE
- Medical subject headings
- Warts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EndWarts® FREEZEDevice
EndWarts® FREEZE is an alternative home cryotherapy device. Patients don't have to go to the hospital to receive treatment for their wart.
Liquid nitrogenDevice
Also called conventional cryotherapy
Liquid nitrogen is a conventional cryotherapy treatment for cutaneous wart performed by physician at the hospital.
| Study group | Role | What they receive |
|---|---|---|
| EndWarts® FREEZE in Soft keratin | Active comparator | EndWarts® FREEZE were treated to 11 patients with wart at soft keratin Receives: Device: EndWarts® FREEZE |
| EndWarts® FREEZE in Hard keratin | Active comparator | EndWarts® FREEZE were treated to 11 patients with wart at hard keratin Receives: Device: EndWarts® FREEZE |
| Liquid nitrogen in Soft keratin | Active comparator | Liquid nitrogen were treated to 11 patients with wart at soft keratin Receives: Device: Liquid nitrogen |
| Liquid nitrogen in Hard keratin | Active comparator | Liquid nitrogen were treated to 11 patients with wart at hard keratin Receives: Device: Liquid nitrogen |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (1)
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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2021
- Study start12 Nov 2020
- Primary completion14 Jan 2022
- Study completion14 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Cryotherapy EffectStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Charussri Leeyaphan, Assoc. Prof., Principal investigator, Department of Dermatology Faculty of Medicine, Siriraj Hospital Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04781244
- Sponsor's protocol ID
- EndWart
- Status last verified
- Mar 2024
- First submitted
- 25 Feb 2021
- Last updated
- 19 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29214505Ghadgepatil 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.
PubMed 27047542Lipke MM. An armamentarium of wart treatments. Clin Med Res. 2006 Dec;4(4):273-93. doi: 10.3121/cmr.4.4.273.
PubMed 17210977Sterling 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.
PubMed 25273231Bruggink 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.
PubMed 20837684
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cost-effectiveness of EndWarts® FREEZE for Wart Treatment: A Randomized, Controlled, Investigator-Blinded, Comparative Study
- ClinicalTrials.gov ID
- NCT04781244
- Acronym / sponsor ID
- EndWart
- Conditions
- Cryotherapy Effect, Warts
- Keywords
- cryotherapy effect, warts, treatment, EndWarts FREEZE
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 12 Nov 2020 (actual)
- Primary completion
- 14 Jan 2022 (actual)
- Study completion
- 14 Jan 2022 (actual)
- First posted
- 4 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| EndWarts® FREEZE in Soft keratin | Active comparator | Device: EndWarts® FREEZEEndWarts® FREEZE were treated to 11 patients with wart at soft keratin |
| EndWarts® FREEZE in Hard keratin | Active comparator | Device: EndWarts® FREEZEEndWarts® FREEZE were treated to 11 patients with wart at hard keratin |
| Liquid nitrogen in Soft keratin | Active comparator | Device: Liquid nitrogenLiquid nitrogen were treated to 11 patients with wart at soft keratin |
| Liquid nitrogen in Hard keratin | Active comparator | Device: Liquid nitrogenLiquid nitrogen were treated to 11 patients with wart at hard keratin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosis of plantar or common wart at Department of Dermatology, Siriraj hospital
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EndWarts® FREEZEEndWarts® FREEZE is an alternative home cryotherapy device. Patients don't have to go to the hospital to receive treatment for their wart. | Device | EndWarts® FREEZE in Hard keratin, EndWarts® FREEZE in Soft keratin |
| Liquid nitrogenAlso: conventional cryotherapyLiquid nitrogen is a conventional cryotherapy treatment for cutaneous wart performed by physician at the hospital. | Device | Liquid nitrogen in Hard keratin, Liquid nitrogen in Soft keratin |
Primary outcome
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.
1 secondary outcome
Compared Dermatology quality of life index before and after treatment
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2024.
- Results publication: PubMed 29214505Walczuk 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.
- Results publication: PubMed 27047542Ghadgepatil 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.
- Results publication: PubMed 17210977Lipke MM. An armamentarium of wart treatments. Clin Med Res. 2006 Dec;4(4):273-93. doi: 10.3121/cmr.4.4.273.
- Results publication: PubMed 25273231Sterling 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.
- Results publication: PubMed 20837684Bruggink 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charussri Leeyaphan, Assoc. Prof. principal investigator
Department of Dermatology Faculty of Medicine, Siriraj Hospital Mahidol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EndWarts® FREEZE and Liquid nitrogen in people with Cryotherapy Effect and Warts, run by Mahidol University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cost-effectiveness of EndWarts® FREEZE (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04781244, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2024.