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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03734003
Recruitment Status : Completed
First Posted : November 7, 2018
Last Update Posted : August 20, 2021
Sponsor:
Information provided by (Responsible Party):
Gao Xinghua, First Hospital of China Medical University

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cutaneous Warts Human Papilloma Virus Device: liquid nitrogen Device: controllable infrared bioeffect system Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Controllable Infrared Bioeffect Effect for the Treatment of Cutaneous Warts After 3 Months: a Multicenter, Randomized, Open Label Controlled Trial
Actual Study Start Date : August 8, 2018
Actual Primary Completion Date : March 25, 2019
Actual Study Completion Date : June 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Warts

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03734003


Locations
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China, Liaoning
No. 1 Hospital of China Medical University
Shenyang, Liaoning, China, 110001
Sponsors and Collaborators
First Hospital of China Medical University
Investigators
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Study Director: Xinghua Gao No. 1 Hospital of China Medical University
More Information
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Responsible Party: Gao Xinghua, Professor, First Hospital of China Medical University
ClinicalTrials.gov Identifier: NCT03734003    
Other Study ID Numbers: HH20180726
First Posted: November 7, 2018    Key Record Dates
Last Update Posted: August 20, 2021
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gao Xinghua, First Hospital of China Medical University:
hyperthermia
human papilloma virus
cutaneous warts
Additional relevant MeSH terms:
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Warts
Papilloma
Neoplasms, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Papillomavirus Infections
 DNA Virus Infections
Virus Diseases
Infections
Skin Diseases, Viral
Tumor Virus Infections
Skin Diseases, Infectious
Skin Diseases