Randomized Controlled Clinical Trial of Hyperthermia and Hydrogen Peroxide 3% in the Treatment of Cutaneous Warts

Phase

N/A

Condition

Warts

Fever

Treatment

Local Hyperthermia at 44℃

Hydrogen Peroxide 3 % Topical Solution

Clinical Study ID

NCT06812065

GH20210930

Ages 16-65
All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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

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.

Study Design

Local Hyperthermia at 44℃

December 07, 2022

December 31, 2026

Study Description

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

Connect with a study center

Guo Hao
Shenyang, Liaoning 110001
China
Active - Recruiting
infrared hyperthermia device (Patent No: ZL 200820231952.4, Model: YY-WRY-V01, Liaoning Yanyang Medical Instrument Co., Ltd., China)
Shenyang, Liaoning 110001
China
Active - Recruiting

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