A Cohort Study of Hyperthermia and Imiquimod for the Treatment of Flat Warts
Primary Purpose
Human Papilloma Virus
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Imiquimod treatment
Local Hyperthermia at 44℃
Sponsored by
About this trial
This is an interventional treatment trial for Human Papilloma Virus focused on measuring hyperthermia, human papillomavirus virus, flat warts
Eligibility Criteria
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
Sites / Locations
- the First Hospital of China Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Local Hyperthermia at 44℃ for falt warts
Imiquimod for Flat Warts
Arm Description
Local hyperthermia at 44℃ for 30 mins on one lesion region, at days of 1,2,3, 15, 16, 21 and 28.
Miquimod treatment: 3 times a week for 1 month
Outcomes
Primary Outcome Measures
clearance rates of HPV
to evaluate the clearance rates of all lesions in different treatment groups 3 month after treatment.
Secondary Outcome Measures
effective rates of HPV
to evaluate the effective rates of all lesions in different treatment groups 3 month after treatment.
Full Information
NCT ID
NCT05146895
First Posted
August 17, 2021
Last Updated
November 23, 2021
Sponsor
First Hospital of China Medical University
1. Study Identification
Unique Protocol Identification Number
NCT05146895
Brief Title
A Cohort Study of Hyperthermia and Imiquimod for the Treatment of Flat Warts
Official Title
Evaluation of Local Hyperthermia for the Treatment of Flat Warts After 4 Months: a Single-center, Single-blind, Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
October 20, 2018 (Actual)
Primary Completion Date
June 20, 2022 (Anticipated)
Study Completion Date
June 20, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
First Hospital of China Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Human Papilloma Virus
Keywords
hyperthermia, human papillomavirus virus, flat warts
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Local Hyperthermia at 44℃ for falt warts
Arm Type
Experimental
Arm Description
Local hyperthermia at 44℃ for 30 mins on one lesion region, at days of 1,2,3, 15, 16, 21 and 28.
Arm Title
Imiquimod for Flat Warts
Arm Type
Active Comparator
Arm Description
Miquimod treatment: 3 times a week for 1 month
Intervention Type
Drug
Intervention Name(s)
Imiquimod treatment
Intervention Description
As an control arm, for patients with flat warts
Intervention Type
Device
Intervention Name(s)
Local Hyperthermia at 44℃
Intervention Description
As an experimental arm, for patients with flat warts
Primary Outcome Measure Information:
Title
clearance rates of HPV
Description
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 Outcome Measure Information:
Title
effective rates of HPV
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xinghua Gao
Phone
+86 139 4015 2467
Email
gaobarry@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Shengnan Zhao
Phone
+15104042205
Email
zsn15104042205@126.com
Facility Information:
Facility Name
the First Hospital of China Medical University
City
Shenyang
ZIP/Postal Code
110001
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
xinghua gao
Phone
13940152467
Email
gaobarry@hotmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Cohort Study of Hyperthermia and Imiquimod for the Treatment of Flat Warts
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