Infrared Bioeffect System for the Treatment of Cutaneous Warts

NCT ID: NCT03734003

Last Updated: 2021-08-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-08
• Study Completion Date: 2020-06-01

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.

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.

Conditions

Cutaneous Warts; Human Papilloma Virus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

controllable infrared bioeffect system

Intervention Type: DEVICE

As an experimental arm, for patients with cutaneous warts

Liquid nitrogen cryotherapy for cutaneous warts

Liquid nitrogen crytotherapy at days 1, 15, 30.

Group Type: ACTIVE_COMPARATOR

liquid nitrogen

Intervention Type: DEVICE

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

Interventions

liquid nitrogen

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

Intervention Type: DEVICE

controllable infrared bioeffect system

As an experimental arm, for patients with cutaneous warts

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

First Hospital of China Medical University

OTHER

Sponsor Role: lead

Responsible Party

Gao Xinghua

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xinghua Gao

Role: STUDY_DIRECTOR

No. 1 Hospital of China Medical University

Locations

No. 1 Hospital of China Medical University

Shenyang, Liaoning, China

Countries

China

References

Qi RQ, Zhou J, Xiao B, Xu H, Qiao S, Zhu P, Xia L, Yang Y, Zhang L, Yan H, He C, Sun Y, Niu X, Zhang Y, Fu L, Wang X, Chen HD, Li S, Gao XH. Reprint of: Clearance of multiple cutaneous warts by targeting a single lesion: A randomized comparative evaluation of mild local hyperthermia versus cryotherapy. J Am Acad Dermatol. 2023 Mar;88(3):647-649. doi: 10.1016/j.jaad.2023.02.001. Epub 2023 Feb 18. No abstract available.

Reference Type: DERIVED

PMID: 36804149 (View on PubMed)

Other Identifiers

HH20180726

Identifier Type: -

Identifier Source: org_study_id