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Hyperthermia treatment (hyperthermia) refers to treating diseases with temperature (39-45 ° C) beyond normal body temperature,. It has been reported that local warming at 44 ° C is able to effectively mobilize the body's immunity and clear HPV infected lesions, such as condyloma acuminatum and verruca vulgaris, etc.
Hydrogen peroxide (H2O2) is a commonly used disinfectant for skin debridement. It has been reported that high concentration of H2O2 (45% H2O2) is effective in the treatment of warts vulgaris, however, high concentration of H2O2 will cause more local pain, itching and burning sensation. 3% hydrogen peroxide is commonly used as skin debridement disinfectant.
The purpose of the study is to evaluate the efficacy and safety of 44℃ hyperthermia combined with 3% hydrogen peroxide in treating verruca virus.
Mild local Hyperthermia with a certain temperature range has been successfully used to treat some diseases. The warm treatment is usually "all or nothing". "All" means that all viral warts are removed after "warm" treatment, including rashes in non-treated areas. "Nothing" means that some viral warts do not respond to heat. Therefore, further enhancing the therapeutic effect of warmth and improving the reaction of some patients is the priority. Cellular experimental studies have found that low concentrations of dioxygen can promote the secretion of a keratinocyte series of inflammatory factors induced by warming. A randomized parallel control design was used to compare the efficacy of hyperthermia combined with hydrogen peroxide therapy and single use of hyperthermia and hydrogen peroxide alone in the treatment of viral warts. Primary analysis: Modified ITT (all randomized patients receiving ≥1 treatment).Missing data: Multiple imputation using chained equations (MICE)
.Between-group comparisons: ANOVA with Tukey posthoc test for continuous variables; Chi-square with Bonferroni correction for categorical variables.Survival analysis: Cox proportional hazards model adjusted for baseline lesion size
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Local Hyperthermia at 44℃ | Experimental | As an experimental arm. |
|
| Local 3%H2O2 treatment | Experimental | As an experimental arm |
|
| 3%H2O2 for 1 hour, then local hyperthermia at 44℃ for 30 minutes | Experimental | Undergo the hyperthermia treatment of the Local Hyperthermia Group and the dressing treatment of the 3% Hydrogen Peroxide Group. Apply the 3% hydrogen peroxide dressing 1 hour before each hyperthermia session. Local Hyperthermia treats the target warts(largest and most severe warts), while medication addresses all warts. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydrogen Peroxide 3 % Topical Solution | Drug | Dressing: Like the Local Hyperthermia Group, use a cotton ball soaked in 3% hydrogen peroxide. Irradiation: For seven sessions in three weeks, use simulated infrared light (without heat) with the same frequency as the Local Hyperthermia Group. Local Hyperthermia treats the target warts(largest and most severe warts), while medication addresses all warts. |
| Measure | Description | Time Frame |
|---|---|---|
| Complete clearance rate of warts | The complete clearance rate was defined as the proportion of patients with lesions that completely disappeared within 6 months of completing all treatments. | 6 months after the first time of treatment. |
| Time to complete clearance | Median duration from first treatment to complete resolution (days) | 6 months after the first time of treatment. |
| Recurrence rate of warts | Complete clearance was defined as the proportion of patients with complete disappearance of lesions within 6 months of completion of all treatments, and recurrence was the proportion of patients with recurrence of lesions at the cured lesion site within 6 and 12 months after treatment, | recurrence was the proportion of patients with reappearance of lesions at previously cleared sites within 6 months after treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in the size and number of warts at different points in time | Changes in the size and number of warts at different time points (1 week, 2 weeks, 3 weeks, 4 weeks, 12 weeks, 24 weeks) | At 1 week, 2 weeks, 3 weeks, 4 weeks, 12 weeks, 24 weeks follow-up |
| Curative effect of different types of warts |
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Inclusion criteria: The participants were between 16 and 65 years of age, had a clinical diagnosis of viral warts (including common warts, plantar warts, or condyloma acuminatum), and could understand and sign informed consent.
Exclusion criteria: presented with clinically atypical warts; had immunocompromised status or a history of HIV infection; received HPV vaccination within the past 6 months; used immunomodulators, immunosuppressants, or systemic corticosteroids within defined timeframes (4 months and 1 month, respectively); underwent local therapies (e.g., laser, cryotherapy, retinoids) on or near warts within protocol-specified intervals; had a history of cutaneous malignancies or current precancerous lesions; exhibited active dermatologic/systemic diseases (e.g., psoriasis, eczema) or skin conditions (e.g., sunburn) potentially increasing study risks; or were deemed ineligible by investigators for other medical or logistical reasons.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hao Guo | Contact | +86 13840365892 | guohao27@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Xinghua Gao | First Hospital of China Medical University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guo Hao | Recruiting | Shenyang | Liaoning | 110001 | China |
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| ID | Term |
|---|---|
| D014860 | Warts |
| D000084462 | Hyperthermia |
| ID | Term |
|---|---|
| D030361 | Papillomavirus Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D006861 | Hydrogen Peroxide |
| D012996 | Solutions |
| ID | Term |
|---|---|
| D010545 | Peroxides |
| D010087 | Oxides |
| D000838 | Anions |
| D007477 | Ions |
| D004573 |
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Masking Description:
Participants blinded to treatment allocation through:
Outcome assessors blinded to group assignment
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|
| Local Hyperthermia at 44℃ | Device | (Patent No: ZL 200820231952.4, Model: YY-WRY-V01, Liaoning Yanyang Medical Instrument Co., Ltd., China) An infrared hyperthermia device was used to apply local hyperthermia at 44°C to the largest wart. The device includes a heating source, an infrared temperature monitor, an adjusting arm, a control circuit for temperature stabilization, and a display. It uses a tungsten-halogen lamp (wavelength: 760-2300 nm, peak at 1200 nm) to maintain the temperature of a 0.5*0.5 cm skin area within ±0.1°C using a non-contact infrared feedback system.Hyperthermia: Conduct 44-degree Celsius, 30-minute sessions. Do it daily for the first 3 days, then 2 sessions every 7 days for 3 weeks, for a total of 7 sessions. Dressing: Apply a cotton ball soaked in 0.9% saline to the warts, wrap it with plastic film for 1 hour, and do this once a day for 6 weeks. Local Hyperthermia treats the target warts(largest and most severe warts), while medication addresses all warts. |
|
The cure of different types of warts (common warts, plantar warts, condyloma acuminatum) was followed up at 6 months. |
| followed up at 6 months |
| Occurrence of adverse events | occurrence of adverse events (short - and long-term adverse reactions) (e.g. blisters, erythema, nail changes, ulcers/scars, hyperpigmentation, hypopigmentation, erosion) | During treatment and follow-up |
| Treatment-related pain intensity | Pain assessed by Visual Analog Scale (VAS) ranging from 0 (no pain) to 10 (worst imaginable pain) | During each treatment session (Day 1, 2, 3, 10, 11, 18, 19) |
| Patient satisfaction score | Self-reported satisfaction on a 5-point Likert scale (0=very dissatisfied, 5=very satisfied) | At 6-month follow-up |
| infrared hyperthermia device (Patent No: ZL 200820231952.4, Model: YY-WRY-V01, Liaoning Yanyang Medical Instrument Co., Ltd., China) | Recruiting | Shenyang | Liaoning | 110001 | China |
|
| D017193 |
| Skin Diseases, Viral |
| D014412 | Tumor Virus Infections |
| D012874 | Skin Diseases, Infectious |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001832 | Body Temperature Changes |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D018882 | Heat Stress Disorders |
| D014947 | Wounds and Injuries |
| Electrolytes |
| D007287 | Inorganic Chemicals |
| D017382 | Reactive Oxygen Species |
| D005609 | Free Radicals |
| D017601 | Oxygen Compounds |
| D009930 | Organic Chemicals |
| D004364 | Pharmaceutical Preparations |