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

Not Applicable

• Conditions: Human Papilloma Virus
• Interventions: Drug: Imiquimod treatment; Device: Local Hyperthermia at 44℃

• Registration Number: NCT05146895
• Lead Sponsor: First Hospital of China Medical University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-10-20
• Study First Submitted: 2021-08-17
• Status Verified: 2021-11
• Study First Submitted QC: 2021-11-23
• Last Update Submitted: 2021-11-23
• Study First Posted: 2021-12-07
• Last Update Posted: 2021-12-07
• Primary Completion: 2022-06-20
• Study Completion: 2022-06-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Imiquimod for Flat Warts	Imiquimod treatment	Miquimod treatment: 3 times a week for 1 month
Local Hyperthermia at 44℃ for falt warts	Local Hyperthermia at 44℃	Local hyperthermia at 44℃ for 30 mins on one lesion region, at days of 1,2,3, 15, 16, 21 and 28.

Primary Outcome Measures

Name	Time	Method
clearance rates of HPV	3 months after the last time of treatment	to evaluate the clearance rates of all lesions in different treatment groups 3 month after treatment.

Secondary Outcome Measures

Name	Time	Method
effective rates of HPV	3 months after the last time of treatment	to evaluate the effective rates of all lesions in different treatment groups 3 month after treatment.

Trial Locations

Locations (1)

the First Hospital of China Medical University; 🇨🇳 Shenyang, China