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

NCT ID: NCT05146895

Last Updated: 2021-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-20

Study Completion Date

2022-06-20

Brief Summary

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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.

Detailed Description

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Conditions

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Human Papilloma Virus

Keywords

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hyperthermia human papillomavirus virus flat warts

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Local Hyperthermia at 44℃

Intervention Type DEVICE

As an experimental arm, for patients with flat warts

Imiquimod for Flat Warts

Miquimod treatment: 3 times a week for 1 month

Group Type ACTIVE_COMPARATOR

Imiquimod treatment

Intervention Type DRUG

As an control arm, for patients with flat warts

Interventions

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Imiquimod treatment

As an control arm, for patients with flat warts

Intervention Type DRUG

Local Hyperthermia at 44℃

As an experimental arm, for patients with flat warts

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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First Hospital of China Medical University

OTHER

Sponsor Role lead

Responsible Party

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Gao Xinghua

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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the First Hospital of China Medical University

Shenyang, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xinghua Gao

Role: CONTACT

Phone: +86 139 4015 2467

Email: [email protected]

Shengnan Zhao

Role: CONTACT

Phone: +15104042205

Email: [email protected]

Facility Contacts

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xinghua gao

Role: primary

Other Identifiers

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HH20190606

Identifier Type: -

Identifier Source: org_study_id