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

NCT05146895 | Unknown

• 1 other identifier: HH20190606
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Human Papilloma Virus

Keywords

hyperthermia; human papillomavirus virus; flat warts

Outcome Measures

Primary Outcomes (1)

• clearance rates of HPV

  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 Outcomes (1)

• effective rates of HPV

  3 months after the last time of treatment

Study Arms (2)

Local Hyperthermia at 44℃ for falt warts

EXPERIMENTAL

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℃

Imiquimod for Flat Warts

ACTIVE COMPARATOR

Miquimod treatment: 3 times a week for 1 month

Drug: Imiquimod treatment

Interventions

Imiquimod treatment DRUG

As an control arm, for patients with flat warts

Imiquimod for Flat Warts

Local Hyperthermia at 44℃ DEVICE

As an experimental arm, for patients with flat warts

Local Hyperthermia at 44℃ for falt warts

Eligibility Criteria

• Age: 12 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• years old;
• diagnosis confirmed;
• signed informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• First Hospital of China Medical University: lead

Study Sites (1)

the First Hospital of China Medical University

Shenyang, 110001, China

RECRUITING

MeSH Terms

Conditions

Hyperthermia

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Heat Stress Disorders; Wounds and Injuries

Central Study Contacts

Xinghua Gao

CONTACT

+86 139 4015 2467; gaobarry@hotmail.com

Shengnan Zhao

CONTACT

+15104042205; zsn15104042205@126.com

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: August 17, 2021
• First Posted: December 7, 2021
• Study Start: October 20, 2018
• Primary Completion: June 20, 2022
• Study Completion: June 20, 2022
• Last Updated: December 7, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)