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

Study Overview
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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.

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

Conditions
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Human Papilloma Virus

Intervention / Treatment
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* Drug: Imiquimod treatment
* Device: Local Hyperthermia at 44℃


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Local Hyperthermia at 44℃ for falt warts<br>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℃<br>* As an experimental arm, for patients with flat warts<br>|
| Active Comparator: Imiquimod for Flat Warts<br>Miquimod treatment: 3 times a week for 1 month | Drug: Imiquimod treatment<br>* As an control arm, for patients with flat warts<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hyperthermia, human papillomavirus virus, flat warts