NCT03734003

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
88

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 30, 2018

Completed
9 days until next milestone

Study Start

First participant enrolled

August 8, 2018

Completed
3 months until next milestone

First Posted

Study publicly available on registry

November 7, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 25, 2019

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
Last Updated

August 20, 2021

Status Verified

June 1, 2019

Enrollment Period

8 months

First QC Date

July 30, 2018

Last Update Submit

August 19, 2021

Conditions

Cutaneous WartsHuman Papilloma Virus

Keywords

hyperthermiahuman papilloma viruscutaneous warts

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Clearance rate of target lession

    3 months after the last time of treatment

  • Clearance rate of non-target lession

    3 months after the last time of treatment

  • the visual analogue score (VAS) of pain

    3 months after the last time of treatment

  • Clearance rate of virus

    3 months after thelast time of treatment

Study Arms (2)

Controllable infrared bioeffect system for cutaneous warts

EXPERIMENTAL

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

Liquid nitrogen cryotherapy for cutaneous warts

ACTIVE COMPARATOR

Liquid nitrogen crytotherapy at days 1, 15, 30.

Device: liquid nitrogen

Interventions

liquid nitrogenDEVICE

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

Liquid nitrogen cryotherapy for cutaneous warts
controllable infrared bioeffect systemDEVICE

As an experimental arm, for patients with cutaneous warts

Controllable infrared bioeffect system for cutaneous warts

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

No. 1 Hospital of China Medical University

Shenyang, Liaoning, 110001, China

Location

Related Publications (1)

  • 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.

    PMID: 36804149DERIVED

MeSH Terms

Conditions

Hyperthermia

Condition Hierarchy (Ancestors)

Body Temperature ChangesSigns and SymptomsPathological Conditions, Signs and SymptomsHeat Stress DisordersWounds and Injuries

Study Officials

  • Xinghua Gao

    No. 1 Hospital of China Medical University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 30, 2018

First Posted

November 7, 2018

Study Start

August 8, 2018

Primary Completion

March 25, 2019

Study Completion

June 1, 2020

Last Updated

August 20, 2021

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)