Clinical trial NCT03734003: Infrared Bioeffect System for the Treatment of Cutaneous Warts
Official title: Evaluation of Controllable Infrared Bioeffect Effect for the Treatment of Cutaneous Warts After 3 Months: a Multicenter, Randomized, Open Label Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cutaneous Warts
Human Papilloma Virus
Keywords: hyperthermia
human papilloma virus
cutaneous warts
Lead sponsor: First Hospital of China Medical University
Sponsor class: OTHER
First posted: 2018-11-07
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Recovery rate of cutaneous warts
timeFrame: 3 months after the last time of treatment
Secondary outcomes:
measure: Clearance rate of target lession
timeFrame: 3 months after the last time of treatment
measure: Clearance rate of non-target lession
timeFrame: 3 months after the last time of treatment
measure: the visual analogue score (VAS) of pain
timeFrame: 3 months after the last time of treatment
measure: Clearance rate of virus
timeFrame: 3 months after thelast time of treatment
Other outcomes:
Locations:
city: Shenyang
country: China
facility: No. 1 Hospital of China Medical University
state: Liaoning
Study officials:
affiliation: No. 1 Hospital of China Medical University
name: Xinghua Gao
role: STUDY_DIRECTOR
References: