WartsNCT05616078
Laser Versus Cryotherapy for the Treatment of Recalcitrant Warts
A study testing laser treatment and cryotherapy in people with Warts, run by The 306 Hospital of People's Liberation Army.
Trial summary
To evaluate whether laser was superior to cryotherapy for recalcitrant warts Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Warts
- What is being tested?
- laser treatment and cryotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- No sites listed yet
- Study dates
- Nov 2022to Nov 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with HPV2/27/57-induced recalcitrant warts, including periungualor mosaic warts, common or plantar warts with a duration of longer than 1 year, and common or plantar warts previously received no more than two sessions of cryotherapy
- Total number of warts is ≤10 .
- Aged 18 years or older.
Who cannot join
- Patients are currently participating in another trial for the treatment of cutaneous warts.
- Patients have taken immunosuppressant drugs (such as oral corticosteroids) during the past three months.
- Patients have impaired healing eg due to diabetes, vitamin A deficiency, hyperthyroidism and hypothyroidism.
- Patients have autoimmune diseases (such as systemic lupus erythematosus, dermatomyositis, scleroderma or other diseases).
- Patients are pregnant or ready for pregnancies or breast-feeding.
- Patients have cold intolerance (such as cold urticaria, cryoglobulinaemia, cold agglutinin syndrome or Raynaud's syndrome).
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- Patients have local pain intolerance.
- Patients have local hypoesthesia.
- Patients are unable to tolerate laser or cryotherapy.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Laser Versus Cryotherapy for the Treatment of Recalcitrant Warts: a Randomised Controlled Trial
To evaluate whether laser was superior to cryotherapy for recalcitrant warts
Read the detailed description
Patients with recalcitrant warts were randomized equally to receive laser or cryotherapy every 3 to 4 weeks, for a maximum of 4 sessions.The primary outcomes were the cure rate at 16 weeks; secondary outcomes included time to clearance of warts, patient satisfaction with the treatment and treatment-related adverse effects.
- Conditions
- Warts
- Being tested
- laser treatment, cryotherapy
- Medical subject headings
- Warts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laser treatmentOther
a maximum of 4 sessions, with an interval of 3 to 4 weeks
cryotherapyOther
a maximum of 4 sessions, with an interval of 3 to 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| laser treatment | Experimental | LP-Nd:YAG laser treatment Receives: Other: laser treatment |
| cryotherapy | Active comparator | cryotherapy with liquid nitrogen Receives: Other: cryotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
cure rate at 16 weeks
A patient was considered to be cured if all warts were no longer visible and could not be palpated anymore.
Measured: 16 weeks since the initial treatment
Secondary outcomes (3)
time to clearance of warts
The time from treatment initiation until clearance of all warts
Measured: 16 weeks since the initial treatment
patient satisfaction with the treatment
Patient satisfaction was rated on a 5-point scale (from very happy to very unhappy)
Measured: 16 weeks since the initial treatment
treatment-related adverse events
Some adverse effects, including pain, swelling, blisters, hemorrhagic bullae, bruising, and skin breakdown, were recorded by the patients, whereas others, including secondary bacterial infection, hyperpigmentation, hypopigmentation, and scarring were evaluated by a dermatologist
Measured: 16 weeks since the initial treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2022
- Study startNov 2022 (estimated)
- Primary completionNov 2025 (estimated)
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WartsStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The 306 Hospital of People's Liberation Army
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shichao Lu, MD, Principal investigator, The 306 Hospital of People's Liberation Army
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05616078
- Sponsor's protocol ID
- 306PLA-004
- Status last verified
- Nov 2022
- First submitted
- 1 Nov 2022
- Last updated
- 15 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laser Versus Cryotherapy for the Treatment of Recalcitrant Warts: a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT05616078
- Acronym / sponsor ID
- 306PLA-004
- Conditions
- Warts
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- The 306 Hospital of People's Liberation ArmyUniversity, hospital or other
- Study start
- Nov 2022 (estimated)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 15 Nov 2022 (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.
To evaluate whether laser was superior to cryotherapy for recalcitrant warts
Detailed description
Patients with recalcitrant warts were randomized equally to receive laser or cryotherapy every 3 to 4 weeks, for a maximum of 4 sessions.The primary outcomes were the cure rate at 16 weeks; secondary outcomes included time to clearance of warts, patient satisfaction with the treatment and treatment-related adverse effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| laser treatment | Experimental | Other: laser treatmentLP-Nd:YAG laser treatment |
| cryotherapy | Active comparator | Other: cryotherapycryotherapy with liquid nitrogen |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with HPV2/27/57-induced recalcitrant warts, including periungualor mosaic warts, common or plantar warts with a duration of longer than 1 year, and common or plantar warts previously received no more than two sessions of cryotherapy
- Total number of warts is ≤10 .
- Aged 18 years or older.
Key exclusion criteria (9 listed)
- Patients are currently participating in another trial for the treatment of cutaneous warts.
- Patients have taken immunosuppressant drugs (such as oral corticosteroids) during the past three months.
- Patients have impaired healing eg due to diabetes, vitamin A deficiency, hyperthyroidism and hypothyroidism.
- Patients have autoimmune diseases (such as systemic lupus erythematosus, dermatomyositis, scleroderma or other diseases).
- Patients are pregnant or ready for pregnancies or breast-feeding.
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 |
|---|---|---|
| laser treatmenta maximum of 4 sessions, with an interval of 3 to 4 weeks | Other | laser treatment |
| cryotherapya maximum of 4 sessions, with an interval of 3 to 4 weeks | Other | cryotherapy |
Primary outcome
cure rate at 16 weeks
Time frame: 16 weeks since the initial treatment
A patient was considered to be cured if all warts were no longer visible and could not be palpated anymore.
3 secondary outcomes
time to clearance of warts
Time frame: 16 weeks since the initial treatment
patient satisfaction with the treatment
Time frame: 16 weeks since the initial treatment
treatment-related adverse events
Time frame: 16 weeks since the initial treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2022.
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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.
Shichao Lu, MD principal investigator
The 306 Hospital of People's Liberation Army
Questions about this trial
What is this clinical trial studying?
A study testing laser treatment and cryotherapy in people with Warts, run by The 306 Hospital of People's Liberation Army.
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 9 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 15 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
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 Shichao Lu, MD (8610-010-66356984, lvshichao@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cure rate at 16 weeks (time frame: 16 weeks since the initial 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 15 Nov 2022.