Actively Recruiting

Phase Not Applicable
Age: 16Years - 65Years
All Genders
ID06812065

Randomized Controlled Trial of Mild Local Hyperthermia and 3% Hydrogen Peroxide in Treating Multiple Cutaneous Warts by Targeting a Single Lesion

Led by First Hospital of China Medical University · Updated on 2025-02-06

300

Participants Needed

2

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the use of mild local hyperthermia combined with 3% hydrogen peroxide to treat viral warts, including common warts, plantar warts, and condyloma acuminatum. The study aims to assess the safety and effectiveness of warming the skin to 44°C alongside applying hydrogen peroxide to clear wart lesions. This treatment approach is being compared to using either hyperthermia or hydrogen peroxide alone in a randomized clinical trial. Participants receive one of three treatments: local hyperthermia alone applied to the largest wart, topical 3% hydrogen peroxide solution alone with simulated infrared light, or a combination where 3% hydrogen peroxide dressing is applied one hour before a 30-minute session of local hyperthermia at 44°C. Hyperthermia treatments occur daily for three days, then twice weekly for three weeks, totaling seven sessions. Hydrogen peroxide is applied with cotton balls soaked in the solution as a dressing, and saline dressings are used during hyperthermia treatments. During the study, participants are monitored for wart clearance up to six months after treatment begins. Researchers measure complete clearance rates, time to clearance, and recurrence of warts. Secondary assessments include changes in wart size and number, pain during treatment sessions, adverse events, and patient satisfaction. Treatment sessions, follow-up visits, and safety monitoring are conducted over several weeks, with data collected at multiple intervals throughout the six-month period.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 16Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 16 and 65 years
  • Clinical diagnosis of viral warts including common warts, plantar warts, or condyloma acuminatum
  • Ability to understand and sign informed consent
Not Eligible

You will not qualify if you...

  • Presence of clinically atypical warts
  • Immunocompromised status or history of HIV infection
  • HPV vaccination within the past 6 months
  • Use of immunomodulators or immunosuppressants within 4 months
  • Use of systemic corticosteroids within 1 month
  • Local therapies (laser, cryotherapy, retinoids) on or near warts within specified intervals
  • History of cutaneous malignancies or current precancerous lesions
  • Active dermatologic or systemic diseases such as psoriasis or eczema
  • Skin conditions like sunburn that may increase study risks
  • Any other medical or logistical reasons deemed exclusionary by investigators

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 3 weeks

Participants receive assigned treatments including local hyperthermia at 44°C, 3% hydrogen peroxide topical solution, or a combination of both targeting warts. Treatment involves daily sessions initially and additional sessions over three weeks.

7 treatment sessions over 3 weeks with daily sessions for first 3 days and then twice weekly sessions

Follow-up

Duration - Up to 6 months

Participants are monitored for changes in wart size and number, treatment-related pain, adverse events, and recurrence of warts for up to 6 months after treatment.

Visits at 1, 2, 3, 4, 12, and 24 weeks post-treatment

Trial Site Locations

Total: 2 locations

1

Guo Hao

Shenyang, Liaoning, China, 110001

Actively Recruiting

2

infrared hyperthermia device (Patent No: ZL 200820231952.4, Model: YY-WRY-V01, Liaoning Yanyang Medical Instrument Co., Ltd., China)

Shenyang, Liaoning, China, 110001

Actively Recruiting

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Research Team

H

Hao Guo

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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