An interventional study of 3% hydrogen peroxide solution and 0.9 % saline in Warts, sponsored by First Hospital of China Medical University. Recruiting at 1 site in China. Open to participants aged 6 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-04-16.
Sponsored by First Hospital of China Medical University · Not applicable, Interventional, and Treatment
Hyperthermia treatment (hyperthermia) refers to treating diseases with temperature (39-45 ° C) beyond normal body temperature,. It has been reported that local warming at 44 ° C is able to effectively mobilize the body's immunity and clear HPV infected lesions, such as condyloma acuminatum and verruca vulgaris, etc. Significant progress has been made in the application of hyperthermia for viral skin diseases. Clinically, the addition of hydrogen peroxide solution can enhance the efficacy of hyperthermia in treating HPV infection. As a common transdermal drug delivery method, microneedles can increase drug penetration and thereby further improve treatment outcomes. Based on these findings, this study aims to explore an adjunctive approach to hyperthermia for treating viral warts to further enhance therapeutic efficacy.
This study employs a randomized, parallel-group, assessor-blinded design. Participants will be randomly assigned to three groups: hyperthermia alone, hyperthermia combined with microneedle patch (loaded with 0.9% saline), and hyperthermia combined with hydrogen peroxide microneedle patch (experimental group). An adaptive design will be adopted. The sample size is estimated at 70 participants per group, accounting for a potential 20% dropout rate. Interim analyses will be conducted during follow-up, and enrollment will be stopped when a positive result is reached for the primary efficacy endpoint (cure rate), at which point the sample size will be adjusted accordingly.
171 studies on the registry are indexed under Warts; 35 are open to participants now.
This study's planned enrollment of 210 is above the median of 70 across 155 interventional studies indexed under Warts.
Browse Warts studies →First Hospital of China Medical University is the lead sponsor of 62 studies on the registry; 34 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Sterile cotton soaked in normal saline was applied to cover each wart, followed by occlusion with plastic film for one hour, once daily, for six consecutive weeks. One wart was selected to receive 44 °C hyperthermia for 30 minutes per session: three consecutive sessions in the first week, two sessions in the second week, and two sessions in the third week. Hyperthermia was administered immediately after occlusion, during which the wart was rinsed with normal saline and gently dried with a sterile cotton swab before the start of hyperthermia.
Drug: 0.9 % saline · Device: Hyperthermia at 44℃
One wart was selected to receive 44 °C hyperthermia for 30 minutes per session: three consecutive sessions in the first week, two sessions in the second week, and two sessions in the third week. A microneedle patch loaded with 0.9% saline was applied to the target lesion daily for one hour per day, for a total of six weeks.
Drug: 0.9 % saline · Device: Hyperthermia at 44℃ · Device: Microneedle patch
One wart was selected to receive 44 °C hyperthermia for 30 minutes per session: three consecutive sessions in the first week, two sessions in the second week, and two sessions in the third week. A hydrogen peroxide microneedle patch was applied to the target lesion daily for one hour per day, for a total of six weeks.
Drug: 3% hydrogen peroxide solution · Device: Hyperthermia at 44℃ · Device: Microneedle patch
Dressing: Like the Local Hyperthermia Group, use a microneedle patch loaded with 3% hydrogen peroxide . Irradiation: For seven sessions in three weeks, use simulated infrared light (without heat) with the same frequency as the Local Hyperthermia Group. Local Hyperthermia treats the target warts(largest and most severe warts), while medication addresses all warts.
Dressing: Like the Local Hyperthermia Group, use a microneedle patch loaded with 0.9% saline. Irradiation: For seven sessions in three weeks, use simulated infrared light (without heat) with the same frequency as the Local Hyperthermia Group. Local Hyperthermia treats the target warts(largest and most severe warts), while medication addresses all warts.
The infrared hyperthermia device was used as follows: based on the thermal tolerance of different body surface areas, the surface temperature was set to 44 °C ± 1 °C. The lesion was disinfected with alcohol. After the skin had dried, the patient's most painful or largest wart was selected as the target lesion and treated with 44 °C hyperthermia. The treatment was administered for three consecutive days (sessions), each lasting 30 minutes. After an interval of 7-10 days, the same target lesion received two consecutive days (sessions) of treatment, followed by one session every 7-10 days thereafter. For patients with multiple lesions, only one target lesion was treated using the above protocol, while the remaining lesions received no intervention.
Purpose: To facilitate drug loading. Instructions:Add an appropriate amount of 3% hydrogen peroxide solution or 0.9% sodium chloride solution into the corresponding chamber. Apply the microneedle patch to the wart and secure it with tape. Press the raised part of the aluminum film sequentially with fingers until the chamber fully collapses and makes contact with the skin. After one hour of contact, dispose of the patch in a medical waste container.
Complete clearance rate of warts
The complete clearance rate was defined as the proportion of patients with lesions that completely disappeared within 6 months of completing all treatments.
Time frame: 6 months after the first time of treatment.
Time to complete clearance
Median duration from first treatment to complete resolution (days)
Time frame: 6 months after the first time of treatment.
Recurrence rate of warts
Complete clearance was defined as the proportion of patients with complete disappearance of lesions within 6 months of completion of all treatments, and recurrence was the proportion of patients with recurrence of lesions at the cured lesion site within 6 and 12 months after treatment.
Time frame: Recurrence was the proportion of patients with reappearance of lesions at previously cleared sites within 6 months after treatment.
Changes in the size and number of warts at different points in time
Time frame: At months 1, 3, and 6
Occurrence of adverse events
Occurrence of adverse events (short - and long-term adverse reactions) (e.g. blisters, erythema, nail changes, ulcers/scars, hyperpigmentation, hypopigmentation, erosion)
Time frame: During treatment and follow-up
Treatment-related pain intensity
Pain assessed by Visual Analog Scale (VAS) ranging from 0 (no pain) to 10 (worst imaginable pain)
Time frame: During each treatment session (Day 1, 2, 3, 10, 11, 18, 19)
Time to first wart clearance
Time frame: At months 1, 3, and 6
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for May 2026; primary completion for Dec 2028, 31 months later.
Of 28 interventional studies with no phase under Warts, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 31. This study's planned 31 months is above that.
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Studies of the drug tested here: Hydrogen Peroxide
First Hospital of China Medical University