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

ConditionWarts
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age16-65
SponsorFirst Hospital of China Medical University

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Hydrogen Peroxide 3 % Topical Solution

    Drug

    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.

  • Local Hyperthermia at 44℃

    Device

    (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.

Treatment groups

300 Participants
are divided into 3 treatment groups
Group A: Local Hyperthermia at 44℃Experimental treatment 1 intervention
Group B: Local 3%H2O2 treatmentExperimental treatment 1 intervention
Group C: 3%H2O2 for 1 hour, then local hyperthermia at 44℃ for 30 minutesExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Complete clearance rate of warts

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.
2

Time to complete clearance

Median duration from first treatment to complete resolution (days)

Time frame
6 months after the first time of treatment.
3

Recurrence rate of warts

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
recurrence was the proportion of patients with reappearance of lesions at previously cleared sites within 6 months after treatment.

Secondary outcomes

1

Changes in the size and number of warts at different points in time

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
At 1 week, 2 weeks, 3 weeks, 4 weeks, 12 weeks, 24 weeks follow-up
2

Curative effect of different types of warts

The cure of different types of warts (common warts, plantar warts, condyloma acuminatum) was followed up at 6 months.

Time frame
followed up at 6 months
3

Occurrence of adverse events

occurrence of adverse events (short - and long-term adverse reactions) (e.g. blisters, erythema, nail changes, ulcers/scars, hyperpigmentation, hypopigmentation, erosion)

Time frame
During treatment and follow-up
4

Treatment-related pain intensity

Pain assessed by Visual Analog Scale (VAS) ranging from 0 (no pain) to 10 (worst imaginable pain)

Time frame
During each treatment session (Day 1, 2, 3, 10, 11, 18, 19)

Other outcomes

Sponsors and contacts

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