Efficacy of Laser Versus Cryotherapy in the Treatment of Warts

November 4, 2019 updated by: Shichao Lu, The 306 Hospital of People's Liberation Army

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China, 100101
        • The 306 Hospital of PLA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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 .
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
ACTIVE_COMPARATOR: Cryotherapy
Cryotherapy, at most 4 times
Other: Cryotherapy
up to a maximum of four treatments every 21-28 days
EXPERIMENTAL: laser
laser, at most 4 times
Other: laser
up to a maximum of four treatments every 21-28 days

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Cure rate will be calculated at 16 weeks and 6 months from the first treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
effective rate
Time Frame: Effective rate will be calculated at 16 weeks from the first treatment
Effective assessment is performed by a senior dermatologist.
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
A wart was considered recurrence if there are abnormalities or palpated foreign body in the original place.
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
Cure days was defined as the period from the first treatment until the date of clearance.
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
including pain, swelling, blisters, blood blisters, bruising, bleeding,scarring, hypopigmentation, hyperpigmentation.
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
on a scale of 0-10, where 0 is no pain and 10 is extremely painful
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
on a five-point scale, from 'very satisfied' to 'very satisfied'
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
record the cost after each treatment
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
take a small amount of cutaneous warts lesions and extract HPV DNA before treatment
Relationship between HPV type and curative effect will be analyzed at 16 weeks and 6 months from the first treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The 306 Hospital of People's Liberation Army

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Peking University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Shichao Lu, MD, Dermatology Deparment of the 306 Hospital of PLA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2013

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2015

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 7, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 8, 2013

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 11, 2013

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 6, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 4, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 306PLA-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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