Refactory Warts
Conditions
Keywords
Thermotherapy; Hydrogen peroxide; Refractory viral warts
Brief summary
1. Background of the Problem Viral warts result from infection of the skin or mucous membranes by human papillomavirus (HPV). Some patients develop refractory cases due to abnormal immune function, persistent viral presence, or recurrent warts. The clinical challenge in treating refractory viral warts lies in the limited effectiveness of single therapeutic approaches, high recurrence rates, and the fact that a significant proportion of patients are infected with high-risk or special HPV subtypes. These factors necessitate combined multi-modal treatments and genetic etiological screening. 2. Current Treatment Status Thermotherapy (44°C ± 2°C, 30 minutes per session): Studies have demonstrated that it can stimulate the activation of local immune cells (such as Langerhans cells), thereby enhancing antiviral immune responses. Hydrogen peroxide: It possesses antibacterial properties and promotes tissue repair. In keratinocytes, it can induce thermally induced pyroptosis, thereby enhancing the efficacy of antiviral treatment. 3. HPV genotyping Refractory viral warts are often associated with infection by specific high-risk or low-risk HPV subtypes (e.g., HPV 16, 18, 2, 4, etc.). HPV genotype is closely linked to treatment outcomes and recurrence rates. 4. Relevant pathogenic gene screening This involves exploring intrinsic patient susceptibility, such as genetic polymorphisms related to immune function (e.g., HLA typing or Toll-like receptor-related genes). It also includes screening for rare gene mutations, such as mutations in the GATA2, IL2RG, and DOCK8 genes, which lead to impaired viral clearance and a propensity to develop multiple viral warts.
Interventions
DEVICEAn infrared hyperthermia device
(Patent No: ZL 200820231952.4, Model: YY-WRY-V01, Liaoning Yanyang Medical Instrument Co., Ltd., China) An infrared hyperthermia device was used to apply local hyperthermia at 44°C to the target warts(largest and most severe warts).The device includes a heating source, an infrared temperature monitor, an adjusting arm, a control circuit for temperature stabilization, and a display. It uses a tungsten-halogen lamp (wavelength: 760-2300 nm, peak at 1200 nm) to maintain the temperature of a 0.5\*0.5 cm skin area within ±0.1°C using a non-contact infrared feedback system.Hyperthermia: Conduct 44-degree Celsius, 30-minute sessions. Do it daily for the first 3 days, then 2 sessions every 7 days for 24 weeks.
Dressing: Dress with a cotton ball soaked in 3% hydrogen peroxide one hour prior to each hyperthermia session. Local Hyperthermia treats the target warts(largest and most severe warts), while medication addresses all warts.
The control group used normal saline as the placebo for wet compress, and the hyperthermia treatment was the same as that of the trial group.
Sponsors
First Hospital of China Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
\- 1: Patients with a disease course of ≥2 years who have failed to respond to ≥2 treatment methods (such as topical ointments, cryotherapy, laser therapy, etc.) 2: The subject or their legal guardian is able to understand and sign the informed consent form/agree to participate in the study.
Exclusion criteria
* 1: The subject or their legal guardian is unable to understand and refuses to sign the informed consent form / refuses to participate in the study 2: Individuals allergic to local hyperthermia or hydrogen peroxide; 3: Subjects with tumors or other serious diseases are unable to complete this clinical study; 4: Due to personal or other objective reasons, it is not possible to ensure timely treatment and follow-up.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete clearance rate of warts within 6 months | 6 months after the first time of treatment. | The complete clearance rate was defined as the proportion of patients with lesions that completely disappeared within 6 months of completing all treatments. |
| Recurrence rate of warts | recurrence was the proportion of patients with reappearance of lesions at previously cleared sites within 6,12 months after treatment. | Recurrence was the proportion of patients with recurrence of lesions at the cured lesion site within 6 and 12 months after treatment. |
| Complete clearance rate of warts within 3 months | 3 months after the first time of treatment. | The complete clearance rate was defined as the proportion of patients with lesions that completely disappeared within 3 months of completing all treatments. |
| HPV genotyping | Pre-treatment and 3,6 months after the first time of treatment | Collect the tissue sample from the wart for HPV gene testing. |
| Pathogenic Gene Screening Analysis | Pre-treatment | Collecting patient blood samples for pathogenic gene screening |
| Immune-related cytokines | Pre-treatment and 3,6 months after the first time of treatment | Collecting the patient's blood samples to test immune-related cytokines |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in the size and number of warts at different points in time | At 1 week, 2 weeks, 3 weeks, 4 weeks, 12 weeks, 24 weeks follow-up | Changes in the size and number of warts at different time points (1 week, 2 weeks, 3 weeks, 4 weeks, 12 weeks, 24 weeks) |
| Curative effect of different types of warts | followed up at 6 months. | The cure of different types of warts (common warts, plantar warts, condyloma acuminatum) was followed up at 6 months. |
| Occurrence of adverse events | During treatment and follow-up | occurrence of adverse events (short - and long-term adverse reactions) (e.g. blisters, erythema, nail changes, ulcers/scars, hyperpigmentation, hypopigmentation, erosion) |
| Treatment-related pain intensity | During each treatment session (Day 1, 2, 3, 10, 11, 18, 19, 26, ....180) | Pain assessed by Visual Analog Scale (VAS) ranging from 0 (no pain) to 10 (worst imaginable pain) |
| Patient satisfaction score | At 6-month follow-up | Self-reported satisfaction on a 5-point Likert scale (0=very dissatisfied, 5=very satisfied) |
Countries
China
Contacts
CONTACTXinghua Gao
Outcome results
None listed