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

Human Papilloma Virus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05146895
• Other study ID #: HH20190606
• Status: Recruiting
• Phase: N/A
• Start date: October 20, 2018
• Est. completion date: June 20, 2022

Study information

• Verified date: November 2021
• Source: First Hospital of China Medical University
• Contact: Xinghua Gao
• Phone: +86 139 4015 2467
• Email: gaobarry[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 20, 2022
• Est. primary completion date: June 20, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Fever
• Human Papilloma Virus
• Hyperthermia
• Papilloma

Intervention

Drug:
• Imiquimod treatment
As an control arm, for patients with flat warts

Device:
• Local Hyperthermia at 44?
As an experimental arm, for patients with flat warts

Locations

Country	Name	City	State
China	the First Hospital of China Medical University	Shenyang

Sponsors (1)

Lead Sponsor	Collaborator
First Hospital of China Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	effective rates of HPV	to evaluate the effective rates of all lesions in different treatment groups 3 month after treatment.	3 months after the last time of treatment