Clinical trial NCT06812065: Randomized Controlled Clinical Trial of Hyperthermia and Hydrogen Peroxide 3% in the Treatment of Cutaneous Warts
Official title: Rrandomized Controlled Clinical Trial Named Mild Local Hyperthermia and Hydrogen Peroxide Treat Multiple Warts by Targeting a Single Lesion.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Warts
Keywords: hyperthermia
Warts
Hydrogen Peroxide
Lead sponsor: First Hospital of China Medical University
Sponsor class: OTHER
First posted: 2025-02-06
Enrollment: 300
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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

Eligibility 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.

Primary outcomes:
measure: Complete clearance rate of warts
timeFrame: 6 months after the first time of treatment.
measure: Time to complete clearance
timeFrame: 6 months after the first time of treatment.
measure: Recurrence rate of warts
timeFrame: recurrence was the proportion of patients with reappearance of lesions at previously cleared sites within 6 months after treatment.
Secondary outcomes:
measure: Changes in the size and number of warts at different points in time
timeFrame: At 1 week, 2 weeks, 3 weeks, 4 weeks, 12 weeks, 24 weeks follow-up
measure: Curative effect of different types of warts
timeFrame: followed up at 6 months
measure: Occurrence of adverse events
timeFrame: During treatment and follow-up
measure: Treatment-related pain intensity
timeFrame: During each treatment session (Day 1, 2, 3, 10, 11, 18, 19)
measure: Patient satisfaction score
timeFrame: At 6-month follow-up
Other outcomes:
Locations:
city: Shenyang
country: China
facility: Guo Hao
state: Liaoning
city: Shenyang
country: China
facility: infrared hyperthermia device (Patent No: ZL 200820231952.4, Model: YY-WRY-V01, Liaoning Yanyang Medical Instrument Co., Ltd., China)
state: Liaoning
Study officials:
affiliation: First Hospital of China Medical University
name: Xinghua Gao
role: STUDY_DIRECTOR
References: