Infrared Bioeffect System for the Treatment of Cutaneous Warts

Human Papilloma Virus Clinical Trial

— wart  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03734003
• Other study ID #: HH20180726
• Status: Completed
• Phase: N/A
• Start date: August 8, 2018
• Est. completion date: June 1, 2020

Study information

• Verified date: June 2019
• Source: First Hospital of China Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: June 1, 2020
• Est. primary completion date: March 25, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Cutaneous Warts
• Human Papilloma Virus
• Papilloma
• Warts

Intervention

Device:
• liquid nitrogen
As an active comparator, for patients with cutaneous warts, liquid nitrogen crytherapy is applied
• controllable infrared bioeffect system
As an experimental arm, for patients with cutaneous warts

Locations

Country	Name	City	State
China	No. 1 Hospital of China Medical University	Shenyang	Liaoning

Sponsors (1)

Lead Sponsor	Collaborator
First Hospital of China Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recovery rate of cutaneous warts	to evaluate the clearance rate in different treatment groups 3 months after treatment	3 months after the last time of treatment
Secondary	Clearance rate of target lession	to evaluate the recovery rate of target lession in different treatment groups 3 months after treatment	3 months after the last time of treatment
Secondary	Clearance rate of non-target lession	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
Secondary	the visual analogue score (VAS) of pain	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
Secondary	Clearance rate of virus	to evaluate the clearance rate of virus in different treatment groups 3 months after treatment	3 months after thelast time of treatment