Human Papilloma VirusNCT05146895
A Cohort Study of Hyperthermia and Imiquimod for the Treatment of Flat Warts
A study testing Imiquimod treatment and Local Hyperthermia at 44℃ in people with Human Papilloma Virus, run by First Hospital of China Medical University at 1 site in China.
Trial 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)… Read more about this study
- Who is it for?
- Ages 12 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Human Papilloma Virus
- What is being tested?
- Imiquimod treatment and Local Hyperthermia at 44℃
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 20 Oct 2018to 20 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 12-65 years old;
- diagnosis confirmed;
- signed informed consent
Who cannot join
- 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 locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
the First Hospital of China Medical University
Shenyang, 110001
xinghua gao, 13940152467, gaobarry@hotmail.com
About this study
Official title: Evaluation of Local Hyperthermia for the Treatment of Flat Warts After 4 Months: a Single-center, Single-blind, Randomized Controlled Trial
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.
- Conditions
- Human Papilloma Virus
- Being tested
- Imiquimod treatment, Local Hyperthermia at 44℃
- Keywords
- hyperthermia, human papillomavirus virus, flat warts
- Medical subject headings
- Hyperthermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Imiquimod treatmentDrug
As an control arm, for patients with flat warts
Local Hyperthermia at 44℃Device
As an experimental arm, for patients with flat warts
| Study group | Role | What they receive |
|---|---|---|
| Local Hyperthermia at 44℃ for falt warts | Experimental | Local hyperthermia at 44℃ for 30 mins on one lesion region, at days of 1,2,3, 15, 16, 21 and 28. Receives: Device: Local Hyperthermia at 44℃ |
| Imiquimod for Flat Warts | Active comparator | Miquimod treatment: 3 times a week for 1 month Receives: Drug: Imiquimod treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
clearance rates of HPV
to evaluate the clearance rates of all lesions in different treatment groups 3 month after treatment.
Measured: 3 months after the last time of treatment
Secondary outcomes (1)
effective rates of HPV
to evaluate the effective rates of all lesions in different treatment groups 3 month after treatment.
Measured: 3 months after the last time of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2021
- Study start20 Oct 2018
- Primary completion20 Jun 2022 (estimated)
- Study completion20 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Papilloma VirusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Hospital of China Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gao Xinghua, First Hospital of China Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05146895
- Sponsor's protocol ID
- HH20190606
- Status last verified
- Nov 2021
- First submitted
- 17 Aug 2021
- Last updated
- 7 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Local Hyperthermia for the Treatment of Flat Warts After 4 Months: a Single-center, Single-blind, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05146895
- Acronym / sponsor ID
- HH20190606
- Conditions
- Human Papilloma Virus
- Keywords
- hyperthermia, human papillomavirus virus, flat warts
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- First Hospital of China Medical UniversityUniversity, hospital or other
- Study start
- 20 Oct 2018 (actual)
- Primary completion
- 20 Jun 2022 (estimated)
- Study completion
- 20 Jun 2022 (estimated)
- First posted
- 7 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Local Hyperthermia at 44℃ for falt warts | Experimental | Device: Local Hyperthermia at 44℃Local hyperthermia at 44℃ for 30 mins on one lesion region, at days of 1,2,3, 15, 16, 21 and 28. |
| Imiquimod for Flat Warts | Active comparator | Drug: Imiquimod treatmentMiquimod treatment: 3 times a week for 1 month |
Who may qualify
- Ages
- 12 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 12-65 years old;
- diagnosis confirmed;
- signed informed consent
Key exclusion criteria (6 listed)
- Pregnant woman;
- Local or systematic treatment within 3 months;
- Comorbidity of other severe gynecological inflammation,
- Infection, or tumor;
- Comorbidity of other serious illnesses;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Imiquimod treatmentAs an control arm, for patients with flat warts | Drug | Imiquimod for Flat Warts |
| Local Hyperthermia at 44℃As an experimental arm, for patients with flat warts | Device | Local Hyperthermia at 44℃ for falt warts |
Primary outcome
clearance rates of HPV
Time frame: 3 months after the last time of treatment
to evaluate the clearance rates of all lesions in different treatment groups 3 month after treatment.
1 secondary outcome
effective rates of HPV
Time frame: 3 months after the last time of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Imiquimod treatment and Local Hyperthermia at 44℃ in people with Human Papilloma Virus, run by First Hospital of China Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xinghua Gao (+86 139 4015 2467, gaobarry@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
clearance rates of HPV (time frame: 3 months after the last time of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2021.