Infrared Bioeffect System for the Treatment of Cutaneous Warts (wart)

August 19, 2021 updated by: Gao Xinghua, First Hospital of China Medical University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

88

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Liaoning
      • Shenyang, Liaoning, China, 110001
        • No. 1 Hospital of China Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Controllable infrared bioeffect system for cutaneous warts

Controllable infrared bioeffect system at 44±2℃ for 30 mins on target lesion, at days of 1, 2, 3, 15, 16, 23, 30.

Common warts, plantar warts, and condyloma acuminata
Device: controllable infrared bioeffect system
As an experimental arm, for patients with cutaneous warts
Active Comparator: Liquid nitrogen cryotherapy for cutaneous warts
Liquid nitrogen crytotherapy at days 1, 15, 30.
Device: liquid nitrogen
As an active comparator, for patients with cutaneous warts, liquid nitrogen crytherapy is applied

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 months after the last time of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 months after the last time of treatment
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 months after the last time of treatment
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
3 months after the last time of treatment
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
3 months after thelast time of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Hospital of China Medical University

Investigators

  • Study Director: Xinghua Gao, No. 1 Hospital of China Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 8, 2018

Primary Completion (Actual)

March 25, 2019

Study Completion (Actual)

June 1, 2020

Study Registration Dates

First Submitted

July 30, 2018

First Submitted That Met QC Criteria

November 5, 2018

First Posted (Actual)

November 7, 2018

Study Record Updates

Last Update Posted (Actual)

August 20, 2021

Last Update Submitted That Met QC Criteria

August 19, 2021

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HH20180726

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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