Efficacy of Laser Versus Cryotherapy in the Treatment of Warts

Not Applicable

Completed

• Conditions: Warts
• Interventions: Other: Cryotherapy; Other: laser

• Registration Number: NCT01808443
• Lead Sponsor: The 306 Hospital of People's Liberation Army

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.

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2013-03-07
• Study First Submitted QC: 2013-03-08
• Study First Posted: 2013-03-11
• Primary Completion: 2015-03
• Study Completion: 2016-03
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-04
• Last Update Posted: 2019-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cryotherapy	Cryotherapy	Cryotherapy, at most 4 times
laser	laser	laser, at most 4 times

Primary Outcome Measures

Name	Time	Method
cure rate	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

Secondary Outcome Measures

Name	Time	Method
effective rate	Effective rate will be calculated at 16 weeks from the first treatment	Effective assessment is performed by a senior dermatologist.
recurrence rate	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.
average cure days	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.
patient satisfaction	Patient satisfactionwill be assessed within 3-4 weeks after each treatment	on a five-point scale, from 'very satisfied' to 'very satisfied'
treatment costs	Treatment costs will be recorded within 10 minutes after each treatment	record the cost after each treatment
relationship between HPV type and curative effect	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
side effects	Side effects will be assessed within 3-4 weeks after each treatment	including pain, swelling, blisters, blood blisters, bruising, bleeding,scarring, hypopigmentation, hyperpigmentation.
pain intensity	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

Trial Locations

Locations (1)

The 306 Hospital of PLA; 🇨🇳 Beijing, China