WartsNCT01808443
Efficacy of Laser Versus Cryotherapy in the Treatment of Warts
A study testing Cryotherapy and laser in people with Warts, run by The 306 Hospital of People's Liberation Army at 1 site in China.
Trial summary
The purpose of this study is to test the efficacy of laser versus cryotherapy on the treatment of 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?
- Cryotherapy and laser
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- Mar 2013to Mar 2016
- 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 have cutaneous warts, including common warts(d≥1cm or n≥5 ), plantar warts, periungual warts, mosaic warts, which are suitable for cryotherapy and laser treatment .
- patients aged eighting years and over, who have junior school degree or above
Who cannot join
- Patients who have more than 20 warts
- Patients who are currently participating in another trial for the treatment of their warts
- Patients who took immunosuppressant drugs such as oral corticosteroids within the past three months.
- Patients who are pregnant or ready for pregnancies or breast-feeding.
- Patients who have impaired healing eg due to diabetes, vascular disease, vitamin A deficiency, hyperthyroidism and hypothyroidism.
- Patients who have autoimmune diseases, eg SLE, dermatomyositis, scleroderma and other diseases .
Show all 10Show fewer
- Patients who have cold intolerance, eg cold urticaria, cryoglobulinaemia, cold agglutinin syndrome, Raynaud's syndrome.
- Patients who have local injections intolerance.
- Patients who have local hypoesthesia .
- Patients who can not tolerate cryotherapy or laser treatment for their own reasons.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cryotherapy Versus Laser for the Treatment of Nongenital Cutaneous Warts: A Randomized Controlled Clinical Trial
The purpose of this study is to test the efficacy of laser versus cryotherapy on the treatment of warts
Read the detailed description
Cutaneous warts were a common skin diseases caused by human papilloma virus (HPV) infection. Although warts may spontaneously resolve, many patients seek for treatment for various reasons. There are many kinds of treatments for cutaneous warts, including salicylic acid, cryotherapy, laser, etc. A recent high quality RCT confirmed that the cure rate of topical salicylic acid and frozen has no difference at six months, but the efficacy of laser versus cryotherapy on the treatment of warts remains unclear. Therefore, we designed a randomized controlled trial to test the efficacy of laser versus cryotherapy on the treatment of warts.
- Conditions
- Warts
- Being tested
- Cryotherapy, laser
- Keywords
- cryotherapy, laser, cutaneous warts
- Medical subject headings
- Warts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CryotherapyOther
up to a maximum of four treatments every 21-28 days
laserOther
up to a maximum of four treatments every 21-28 days
| Study group | Role | What they receive |
|---|---|---|
| Cryotherapy | Active comparator | Cryotherapy, at most 4 times Receives: Other: Cryotherapy |
| laser | Experimental | laser, at most 4 times Receives: Other: laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
cure rate
Warts was considered cured if they was no longer visible and could not be palpated anymore by hand. Assessment of whether or not cured was performed on site by a senior dermatologist
Measured: Cure rate will be calculated at 16 weeks and 6 months from the first treatment
Secondary outcomes (8)
effective rate
Effective assessment is performed by a senior dermatologist.
Measured: Effective rate will be calculated at 16 weeks from the first treatment
recurrence rate
A wart was considered recurrence if there are abnormalities or palpated foreign body in the original place.
Measured: Recurrence rate will be calculated at 12 months from the first treatment
average cure days
Cure days was defined as the period from the first treatment until the date of clearance.
Measured: Average cure days will be calculated at 6 months from the first treatment
side effects
including pain, swelling, blisters, blood blisters, bruising, bleeding,scarring, hypopigmentation, hyperpigmentation.
Measured: Side effects will be assessed within 3-4 weeks after each treatment
pain intensity
on a scale of 0-10, where 0 is no pain and 10 is extremely painful
Measured: Pain intensity will be assessed within 3-4 weeks after each treatment
patient satisfaction
on a five-point scale, from 'very satisfied' to 'very satisfied'
Measured: Patient satisfactionwill be assessed within 3-4 weeks after each treatment
treatment costs
record the cost after each treatment
Measured: Treatment costs will be recorded within 10 minutes after each treatment
relationship between HPV type and curative effect
take a small amount of cutaneous warts lesions and extract HPV DNA before treatment
Measured: Relationship between HPV type and curative effect will be analyzed at 16 weeks and 6 months from the first treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2013 (estimated)
- Study startMar 2013
- Primary completionMar 2015
- Study completionMar 2016
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
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- The 306 Hospital of People's Liberation Army
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University
- Responsible party
- Principal investigator, Shichao Lu, The 306 Hospital of People's Liberation Army
- Investigators
- Shichao Lu, MD, Principal investigator, Dermatology Deparment of the 306 Hospital of PLA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01808443
- Sponsor's protocol ID
- 306PLA-001
- Status last verified
- Nov 2019
- First submitted
- 7 Mar 2013
- Last updated
- 6 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cryotherapy Versus Laser for the Treatment of Nongenital Cutaneous Warts: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT01808443
- Acronym / sponsor ID
- 306PLA-001
- Conditions
- Warts
- Keywords
- cryotherapy, laser, cutaneous warts
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- The 306 Hospital of People's Liberation ArmyUniversity, hospital or other
- Collaborators
- Peking University
- Study start
- Mar 2013 (actual)
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 11 Mar 2013 (estimated)
- 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.
The purpose of this study is to test the efficacy of laser versus cryotherapy on the treatment of warts
Detailed description
Cutaneous warts were a common skin diseases caused by human papilloma virus (HPV) infection. Although warts may spontaneously resolve, many patients seek for treatment for various reasons. There are many kinds of treatments for cutaneous warts, including salicylic acid, cryotherapy, laser, etc. A recent high quality RCT confirmed that the cure rate of topical salicylic acid and frozen has no difference at six months, but the efficacy of laser versus cryotherapy on the treatment of warts remains unclear. Therefore, we designed a randomized controlled trial to test the efficacy of laser versus cryotherapy on the treatment of warts.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cryotherapy | Active comparator | Other: CryotherapyCryotherapy, at most 4 times |
| laser | Experimental | Other: laserlaser, at most 4 times |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients have cutaneous warts, including common warts(d≥1cm or n≥5 ), plantar warts, periungual warts, mosaic warts, which are suitable for cryotherapy and laser treatment .
- patients aged eighting years and over, who have junior school degree or above
Key exclusion criteria (10 listed)
- Patients who have more than 20 warts
- Patients who are currently participating in another trial for the treatment of their warts
- Patients who took immunosuppressant drugs such as oral corticosteroids within the past three months.
- Patients who are pregnant or ready for pregnancies or breast-feeding.
- Patients who have impaired healing eg due to diabetes, vascular disease, vitamin A deficiency, hyperthyroidism and hypothyroidism.
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 |
|---|---|---|
| Cryotherapyup to a maximum of four treatments every 21-28 days | Other | Cryotherapy |
| laserup to a maximum of four treatments every 21-28 days | Other | laser |
Primary outcome
cure rate
Time frame: Cure rate will be calculated at 16 weeks and 6 months from the first treatment
Warts was considered cured if they was no longer visible and could not be palpated anymore by hand. Assessment of whether or not cured was performed on site by a senior dermatologist
8 secondary outcomes
effective rate
Time frame: Effective rate will be calculated at 16 weeks from the first treatment
recurrence rate
Time frame: Recurrence rate will be calculated at 12 months from the first treatment
average cure days
Time frame: Average cure days will be calculated at 6 months from the first treatment
side effects
Time frame: Side effects will be assessed within 3-4 weeks after each treatment
pain intensity
Time frame: Pain intensity will be assessed within 3-4 weeks after each treatment
patient satisfaction
Time frame: Patient satisfactionwill be assessed within 3-4 weeks after each treatment
treatment costs
Time frame: Treatment costs will be recorded within 10 minutes after each treatment
relationship between HPV type and curative effect
Time frame: Relationship between HPV type and curative effect will be analyzed at 16 weeks and 6 months from the first treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2019.
- Individual participant dataSharing planned: Undecided
Related trials for Warts
RecruitingObservational study
Etiology, Pathogenesis, and Natural History of Idiopathic CD4+ Lymphocytopenia
Idiopathic CD4+ Lymphocytopenia, Cryptococcal Meningitis
Not yet recruiting
Efficacy and Safety of Oral Ivermectin for Genital Warts
Genital Warts
Enrolling by invitationPhase 1/2
Base-Edited Hematopoietic Stem/Progenitor Cell Gene Therapy for Treatment of CXCR4-WHIM
WHIM, Warts
Active, not recruitingPhase 3
Cantharidin Application in Patients With Common Warts (Verruca Vulgaris) (COVE-2)
Common Warts, Common Warts (Verruca Vulgaris)
RecruitingPhase 3
Long-Term Follow-up Study of Cantharidin (YCANTH [VP-102/TO-208]) in Patients With Common Warts (Verruca Vulgaris)
Common Warts (Verruca Vulgaris), Common Warts
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
Dermatology Deparment of the 306 Hospital of PLA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cryotherapy and laser in people with Warts, run by The 306 Hospital of People's Liberation Army 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 2 inclusion and 10 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: finished, as of the sponsor's last update on 6 Nov 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cure rate (time frame: Cure rate will be calculated at 16 weeks and 6 months from the first 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 6 Nov 2019.