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Efficacy of Laser Versus Cryotherapy in the Treatment of Warts

Primary Purpose

Warts

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Cryotherapy
laser
Sponsored by
The 306 Hospital of People's Liberation Army
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Warts focused on measuring cryotherapy, laser, cutaneous warts

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The 306 Hospital of PLA

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Cryotherapy

laser

Arm Description

Cryotherapy, at most 4 times

laser, at most 4 times

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

effective rate
Effective assessment is performed by a senior dermatologist.
recurrence rate
A wart was considered recurrence if there are abnormalities or palpated foreign body in the original place.
average cure days
Cure days was defined as the period from the first treatment until the date of clearance.
side effects
including pain, swelling, blisters, blood blisters, bruising, bleeding,scarring, hypopigmentation, hyperpigmentation.
pain intensity
on a scale of 0-10, where 0 is no pain and 10 is extremely painful
patient satisfaction
on a five-point scale, from 'very satisfied' to 'very satisfied'
treatment costs
record the cost after each treatment
relationship between HPV type and curative effect
take a small amount of cutaneous warts lesions and extract HPV DNA before treatment

Full Information

First Posted
March 7, 2013
Last Updated
November 4, 2019
Sponsor
The 306 Hospital of People's Liberation Army
Collaborators
Peking University
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1. Study Identification

Unique Protocol Identification Number
NCT01808443
Brief Title
Efficacy of Laser Versus Cryotherapy in the Treatment of Warts
Official Title
Cryotherapy Versus Laser for the Treatment of Nongenital Cutaneous Warts: A Randomized Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
March 2013 (Actual)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The 306 Hospital of People's Liberation Army
Collaborators
Peking University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Warts
Keywords
cryotherapy, laser, cutaneous warts

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cryotherapy
Arm Type
Active Comparator
Arm Description
Cryotherapy, at most 4 times
Arm Title
laser
Arm Type
Experimental
Arm Description
laser, at most 4 times
Intervention Type
Other
Intervention Name(s)
Cryotherapy
Intervention Description
up to a maximum of four treatments every 21-28 days
Intervention Type
Other
Intervention Name(s)
laser
Intervention Description
up to a maximum of four treatments every 21-28 days
Primary Outcome Measure Information:
Title
cure rate
Description
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
Time Frame
Cure rate will be calculated at 16 weeks and 6 months from the first treatment
Secondary Outcome Measure Information:
Title
effective rate
Description
Effective assessment is performed by a senior dermatologist.
Time Frame
Effective rate will be calculated at 16 weeks from the first treatment
Title
recurrence rate
Description
A wart was considered recurrence if there are abnormalities or palpated foreign body in the original place.
Time Frame
Recurrence rate will be calculated at 12 months from the first treatment
Title
average cure days
Description
Cure days was defined as the period from the first treatment until the date of clearance.
Time Frame
Average cure days will be calculated at 6 months from the first treatment
Title
side effects
Description
including pain, swelling, blisters, blood blisters, bruising, bleeding,scarring, hypopigmentation, hyperpigmentation.
Time Frame
Side effects will be assessed within 3-4 weeks after each treatment
Title
pain intensity
Description
on a scale of 0-10, where 0 is no pain and 10 is extremely painful
Time Frame
Pain intensity will be assessed within 3-4 weeks after each treatment
Title
patient satisfaction
Description
on a five-point scale, from 'very satisfied' to 'very satisfied'
Time Frame
Patient satisfactionwill be assessed within 3-4 weeks after each treatment
Title
treatment costs
Description
record the cost after each treatment
Time Frame
Treatment costs will be recorded within 10 minutes after each treatment
Title
relationship between HPV type and curative effect
Description
take a small amount of cutaneous warts lesions and extract HPV DNA before treatment
Time Frame
Relationship between HPV type and curative effect will be analyzed at 16 weeks and 6 months from the first treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shichao Lu, MD
Organizational Affiliation
Dermatology Deparment of the 306 Hospital of PLA
Official's Role
Principal Investigator
Facility Information:
Facility Name
The 306 Hospital of PLA
City
Beijing
ZIP/Postal Code
100101
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Efficacy of Laser Versus Cryotherapy in the Treatment of Warts

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