NCT Number: NCT06812065
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.
Interested in participating?
Request Info16 year–65 year
All sexes
Interventional
Not applicable
Guo Hao, Shenyang, Liaoning, China
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
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.
(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.
Time frame: 6 months after the first time of treatment.
The complete clearance rate was defined as the proportion of patients with lesions that completely disappeared within 6 months of completing all treatments.
Time frame: 6 months after the first time of treatment.
Median duration from first treatment to complete resolution (days)
Time frame: recurrence was the proportion of patients with reappearance of lesions at previously cleared sites within 6 months after treatment.
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,
Time frame: At 1 week, 2 weeks, 3 weeks, 4 weeks, 12 weeks, 24 weeks follow-up
Changes in the size and number of warts at different time points (1 week, 2 weeks, 3 weeks, 4 weeks, 12 weeks, 24 weeks)
Time frame: followed up at 6 months
The cure of different types of warts (common warts, plantar warts, condyloma acuminatum) was followed up at 6 months.
Time frame: During treatment and follow-up
occurrence of adverse events (short - and long-term adverse reactions) (e.g. blisters, erythema, nail changes, ulcers/scars, hyperpigmentation, hypopigmentation, erosion)
Time frame: During each treatment session (Day 1, 2, 3, 10, 11, 18, 19)
Pain assessed by Visual Analog Scale (VAS) ranging from 0 (no pain) to 10 (worst imaginable pain)
Time frame: At 6-month follow-up
Self-reported satisfaction on a 5-point Likert scale (0=very dissatisfied, 5=very satisfied)
Contact information is provided by the study sponsor or research team.
First Hospital of China Medical University
Other
Rrandomized Controlled Clinical Trial Named Mild Local Hyperthermia and Hydrogen Peroxide Treat Multiple Warts by Targeting a Single Lesion.
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT00867269
Autoimmune Diseases, Bacterial Infections and Mycoses
Bethesda, Maryland, United States
View Trial DetailsNCT00967785
Agammaglobulinemia, Agranulocytosis
Bethesda, Maryland, United States
View Trial DetailsNCT07457918
Common Warts, Common Warts (Verruca Vulgaris)
Saint Augustine, Florida, United States
View Trial DetailsNCT07534865
DNA Virus Infections, Infections
Shenyang, China
View Trial Details