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

China Medical University

Status: Unknown

Conditions: Human Papilloma Virus

Treatments: Drug: Imiquimod treatment; Device: Local Hyperthermia at 44℃

Study type: Interventional

Funder types: Other

Identifiers

NCT05146895

HH20190606

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 12 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Local Hyperthermia at 44℃ for falt warts

Experimental group

Description:

Local hyperthermia at 44℃ for 30 mins on one lesion region, at days of 1,2,3, 15, 16, 21 and 28.

Treatment:

Device: Local Hyperthermia at 44℃

Imiquimod for Flat Warts

Active Comparator group

Description:

Miquimod treatment: 3 times a week for 1 month

Treatment:

Drug: Imiquimod treatment