A Cohort Study of Hyperthermia and Imiquimod for the Treatment of Flat Warts

November 23, 2021 updated by: Gao Xinghua, First Hospital of China Medical University

Evaluation of Local Hyperthermia for the Treatment of Flat Warts After 4 Months: a Single-center, Single-blind, Randomized Controlled Trial

flat warts are a superficial viral skin disease, extremely common in childhood.Treatment of warts is often difficult and involves different destructive procedures.Although several pharmacological and physical topical treatments are available (keratolytic agents, electrosurgery, cryotherapy, carbon dioxide laser), results are often unsatisfactory in terms of efficacy (frequent recurrence) and cosmetic outcome (scars, inflammatory reactions, transient or permanent hyper- or hypopigmentation).

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 evaluation local hyperthermia in the treatment of flat warts Appropriate control arms were designed for different conditions.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
      • Shenyang, China, 110001
        • Recruiting
        • The First Hospital of China Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 12-65 years old;
  • diagnosis confirmed;
  • signed informed consent

Exclusion Criteria:

  • Pregnant woman;
  • Local or systematic treatment within 3 months;
  • Comorbidity of other severe gynecological inflammation,
  • Infection, or tumor;
  • Comorbidity of other serious illnesses;
  • No guarantee of timely treatment and follow-up

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Local Hyperthermia at 44℃ for falt warts
Local hyperthermia at 44℃ for 30 mins on one lesion region, at days of 1,2,3, 15, 16, 21 and 28.
Device: Local Hyperthermia at 44℃
As an experimental arm, for patients with flat warts
Active Comparator: Imiquimod for Flat Warts
Miquimod treatment: 3 times a week for 1 month
Drug: Imiquimod treatment
As an control arm, for patients with flat warts

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
clearance rates of HPV
Time Frame: 3 months after the last time of treatment
to evaluate the clearance rates of all lesions in different treatment groups 3 month after treatment.
3 months after the last time of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
effective rates of HPV
Time Frame: 3 months after the last time of treatment
to evaluate the effective rates of all lesions in different treatment groups 3 month after treatment.
3 months after the last time of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Hospital of China Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 20, 2018

Primary Completion (Anticipated)

June 20, 2022

Study Completion (Anticipated)

June 20, 2022

Study Registration Dates

First Submitted

August 17, 2021

First Submitted That Met QC Criteria

November 23, 2021

First Posted (Actual)

December 7, 2021

Study Record Updates

Last Update Posted (Actual)

December 7, 2021

Last Update Submitted That Met QC Criteria

November 23, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HH20190606

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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