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NCT Number: NCT03734003

Infrared Bioeffect System for the Treatment of Cutaneous Warts

Local hyperthermia at 44℃ can promote some alterations of immulogical indicators. The procedure is convenient in clinic, has high tolerance with less trauma and less pain. Based on domestic and abroad clinical practice, the investigators observed initially that local hyperthermia brought great benefits to cutaneous warts. In comparison with liquid nitrogen, the safety and efficacy of controllable infrared bioeffect system to treat skin disease has been evaluated. This proved it could be used in treatment of skin warts, and clinical trial met the requirements of Standards for quality control of clinical trials on medical devices, and can be used in product registration and declaration.

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Key information

Conditions

Cutaneous Warts Body Temperature Changes Heat Stress Disorders Human Papilloma Virus Hyperthermia Pathological Conditions, Signs and Symptoms Signs and Symptoms Wounds and Injuries

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

No. 1 Hospital of China Medical University

Shenyang, Liaoning, 110001, China

About this study

Mild local Hyperthermia with a certain temperature range has been successfully used in the treatment of some diseases. It has been utilised in the treatment of some neoplasm, fungal and HPV infections. Investigators' study found that local hyperthermia at 44°C could cleared HPV in more than half of the patients with plantar warts. Investigators also note the fact that in patients with multiple lesions, the clearance of the target lesion is commonly followed by clearance of other distant lesions, a phenomenon suggesting that local hyperthermia could aid in establishing a specific immune response to eliminate HPV.So the purpose of the study is to evaluate the safety and efficacy of controllable infrared bioeffect system to treat cutaneous warts. This trial was designed into two groups, one was experimental group (thermal therapy group), the other one was control group (liquid nitrogen cryotherapy group). The ratio of participants was 1:1 in experiment group and control group. The main evaluation indicator was the recovery rate after 4 months of initial treatment.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

18-70 years old signed informed consent clinical diagnosed HPV induced cutaneous warts no local or systemic therapy within 3 months effective contraception for 6 months after signed informed consent

Exclusion criteria

HbsAg(+), HCV-Ab(+), HIV-Ab(+) skin lesions associated with other infections pregnant or breast-feeding woman unsuitable to be treated by liquid nitrogen cryotherapy scar diathesis

Treatment and study plan

Liquid nitrogen

Device

As an active comparator, for patients with cutaneous warts, liquid nitrogen crytherapy is applied

controllable infrared bioeffect system

Device

As an experimental arm, for patients with cutaneous warts

Primary outcomes

  1. Recovery rate of cutaneous warts

    Time frame: 3 months after the last time of treatment

    to evaluate the clearance rate in different treatment groups 3 months after treatment

Secondary outcomes

  1. Clearance rate of target lession

    Time frame: 3 months after the last time of treatment

    to evaluate the recovery rate of target lession in different treatment groups 3 months after treatment

  2. Clearance rate of non-target lession

    Time frame: 3 months after the last time of treatment

    to evaluate the recovery rate of non-target lession in different treatment groups 3 months after treatment

  3. the visual analogue score (VAS) of pain

    Time frame: 3 months after the last time of treatment

    to evaluate the score of VAS (0 score represents no pain; 10 score represents sharp pain) in different treatment groups 3 months after treatment

  4. Clearance rate of virus

    Time frame: 3 months after thelast time of treatment

    to evaluate the clearance rate of virus in different treatment groups 3 months after treatment

Sponsors and collaborators

Lead sponsor

First Hospital of China Medical University

Other

Registry information

Official study title

Evaluation of Controllable Infrared Bioeffect Effect for the Treatment of Cutaneous Warts After 3 Months: a Multicenter, Randomized, Open Label Controlled Trial

Acronym: wart

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Nov 7, 2018
Registry last updated
Aug 20, 2021

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.

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