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

China Medical University

Status: Enrolling

Conditions: Warts

Treatments: Device: Local Hyperthermia at 44℃; Drug: Hydrogen Peroxide 3 % Topical Solution

Study type: Interventional

Funder types: Other

Identifiers

NCT06812065

GH20210930

Details and patient eligibility

About

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.

Full 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

Enrollment: 300 estimated patients

Sex: All

Ages: 16 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 3 patient groups

Local Hyperthermia at 44℃

Experimental group

Description:

As an experimental arm.

Treatment:

Device: Local Hyperthermia at 44℃

Local 3%H2O2 treatment

Experimental group

Description:

As an experimental arm

Treatment:

Drug: Hydrogen Peroxide 3 % Topical Solution

3%H2O2 for 1 hour, then local hyperthermia at 44℃ for 30 minutes

Experimental group

Description:

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.

Treatment:

Drug: Hydrogen Peroxide 3 % Topical Solution

Device: Local Hyperthermia at 44℃