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

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05146895

Enrollment

Registered

2021-12-07

Start date

2018-10-20

Completion date

2022-06-20

Last updated

2021-12-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Human Papilloma Virus

Keywords

hyperthermia, human papillomavirus virus, flat warts

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.

Interventions

DRUGImiquimod treatment

As an control arm, for patients with flat warts

DEVICELocal Hyperthermia at 44℃

As an experimental arm, for patients with flat warts

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

12 Years to 65 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

China

Contacts

Primary ContactXinghua Gao

gaobarry@hotmail.com+86 139 4015 2467

Backup ContactShengnan Zhao

zsn15104042205@126.com+15104042205

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026