Cryotherapy Effect, Warts
Conditions
Keywords
cryotherapy effect, warts, treatment, EndWarts FREEZE
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.
Interventions
DEVICEEndWarts® FREEZE
EndWarts® FREEZE is an alternative home cryotherapy device. Patients don't have to go to the hospital to receive treatment for their wart.
DEVICELiquid nitrogen
Liquid nitrogen is a conventional cryotherapy treatment for cutaneous wart performed by physician at the hospital.
Sponsors
Mahidol University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cost-effectiveness of EndWarts® FREEZE | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Compared Dermatology quality of life index before and after treatment | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Patient satisfaction of EndWarts® FREEZE | 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. |
| Compared side effect after treatment | 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. |
Countries
Thailand
Outcome results
None listed