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

Sponsor
First Hospital of China Medical University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05146895
Collaborator
(none)
60
1
2
44
1.4

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Imiquimod treatment
  • Device: Local Hyperthermia at 44℃
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Evaluation of Local Hyperthermia for the Treatment of Flat Warts After 4 Months: a Single-center, Single-blind, Randomized Controlled Trial
Actual Study Start Date :
Oct 20, 2018
Anticipated Primary Completion Date :
Jun 20, 2022
Anticipated Study Completion Date :
Jun 20, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. clearance rates of HPV [3 months after the last time of treatment]

    to evaluate the clearance rates of all lesions in different treatment groups 3 month after treatment.

Secondary Outcome Measures

  1. effective rates of HPV [3 months after the last time of treatment]

    to evaluate the effective rates of all lesions in different treatment groups 3 month after treatment.

Eligibility Criteria

Criteria

Ages Eligible for Study:
12 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 the First Hospital of China Medical University Shenyang China 110001

Sponsors and Collaborators

  • First Hospital of China Medical University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Gao Xinghua, professor, First Hospital of China Medical University
ClinicalTrials.gov Identifier:
NCT05146895
Other Study ID Numbers:
  • HH20190606
First Posted:
Dec 7, 2021
Last Update Posted:
Dec 7, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Gao Xinghua, professor, First Hospital of China Medical University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 7, 2021