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.

Overview

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

Interventions

• Drug Hydrogen Peroxide 3 % Topical Solution
  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.
• Device Local Hyperthermia at 44℃
  (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 u

Primary outcome measures

• Complete clearance rate of warts [Time frame: 6 months after the first time of treatment.]
• Time to complete clearance [Time frame: 6 months after the first time of treatment.]
• Recurrence rate of warts [Time frame: recurrence was the proportion of patients with reappearance of lesions at previously cleared sites within 6 months after treatment.]

Secondary outcome measures (5)

• Changes in the size and number of warts at different points in time [Time frame: At 1 week, 2 weeks, 3 weeks, 4 weeks, 12 weeks, 24 weeks follow-up]
• Curative effect of different types of warts [Time frame: followed up at 6 months]
• Occurrence of adverse events [Time frame: During treatment and follow-up]
• Treatment-related pain intensity [Time frame: During each treatment session (Day 1, 2, 3, 10, 11, 18, 19)]
• Patient satisfaction score [Time frame: At 6-month follow-up]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

China · 2 centers

• Guo Hao — Shenyang
• infrared hyperthermia device (Patent No: ZL 200820231952.4, Model: YY-WRY-V01, Liaoning Ya — Shenyang

Identifiers

NCT: NCT06812065 · GH20210930

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗