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Status unknownNCT05146895Updated Dec 7, 2021

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

An interventional study of Imiquimod treatment and Local Hyperthermia at 44℃ in Human Papilloma Virus, sponsored by First Hospital of China Medical University. Status unknown at 1 site in China. Open to participants aged 12 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-12-07.

Sponsored by First Hospital of China Medical University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Nov 2021), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 2 years 9 months after the study started (first participant enrolled Oct 2018, registered Aug 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
12 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Human Papilloma Virus

Keywords

  • hyperthermia
  • human papillomavirus virus
  • flat warts
03

In context

Papilloma

234 studies on the registry are indexed under Papilloma; 28 are open to participants now.

This study's planned enrollment of 60 is below the median of 100 across 159 interventional studies indexed under Papilloma.

Browse Papilloma studies →

Lead sponsor

First Hospital of China Medical University is the lead sponsor of 59 studies on the registry; 32 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
12 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • 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℃

  • Active comparator
    Imiquimod for Flat Warts

    Miquimod treatment: 3 times a week for 1 month

    Drug: Imiquimod treatment

Interventions

  • DrugImiquimod treatment

    As an control arm, for patients with flat warts

  • DeviceLocal Hyperthermia at 44℃

    As an experimental arm, for patients with flat warts

06

What researchers measure

Primary outcomes

  1. clearance rates of HPV

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

    Time frame: 3 months after the last time of treatment

Secondary outcomes

  1. effective rates of HPV

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

    Time frame: 3 months after the last time of treatment

07

Study locations

1 of 1 sites recruiting
  • the First Hospital of China Medical University
    Shenyang, 110001, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 7, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05146895
Lead sponsor
First Hospital of China Medical University
Responsible party
Gao Xinghua (professor, First Hospital of China Medical University) — Principal investigator
First posted
Dec 7, 2021
Start date
Oct 20, 2018
Primary completion
Jun 20, 2022 (estimated)
Completion
Jun 20, 2022 (estimated)
Last update
Dec 7, 2021

Study contacts

Xinghua Gao
Contact
gaobarry@hotmail.com
+86 139 4015 2467
Shengnan Zhao
Contact
zsn15104042205@126.com
+15104042205

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.

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