Efficacy of Laser Versus Cryotherapy in the Treatment of Warts

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: Completed
• Conditions: Warts
• Intervention / Treatment: Other: Cryotherapy; Other: laser

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: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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	Cure rate will be calculated at 16 weeks and 6 months from the first treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
effective rate	Effective assessment is performed by a senior dermatologist.	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.	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.	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.	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	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'	Patient satisfactionwill be assessed within 3-4 weeks after each treatment
treatment costs	record the cost after each treatment	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	Relationship between HPV type and curative effect will be analyzed at 16 weeks and 6 months from the first treatment

Collaborators and Investigators

• Sponsor: The 306 Hospital of People's Liberation Army
• Collaborators: Peking University
• Investigators: Principal Investigator: Shichao Lu, MD, Dermatology Deparment of the 306 Hospital of PLA

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2013
• Primary Completion (ACTUAL): March 1, 2015
• Study Completion (ACTUAL): March 1, 2016

Study Registration Dates

• First Submitted: March 7, 2013
• First Submitted That Met QC Criteria: March 8, 2013
• First Posted (ESTIMATE): March 11, 2013

Study Record Updates

• Last Update Posted (ACTUAL): November 6, 2019
• Last Update Submitted That Met QC Criteria: November 4, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: cryotherapy; laser; cutaneous warts
• Additional Relevant MeSH Terms: Skin Diseases; Virus Diseases; Infections; DNA Virus Infections; Skin Diseases, Infectious; Papillomavirus Infections; Skin Diseases, Viral; Tumor Virus Infections; Warts
• Other Study ID Numbers: 306PLA-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED