Efficacy of Laser Versus Cryotherapy in the Treatment of Warts

Warts Clinical Trial

Official title:

Cryotherapy Versus Laser for the Treatment of Nongenital Cutaneous Warts: A Randomized Controlled Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01808443
• Other study ID #: 306PLA-001
• Status: Completed
• Phase: N/A
• Start date: March 2013
• Est. completion date: March 2016

Study information

• Verified date: November 2019
• Source: The 306 Hospital of People's Liberation Army
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to test the efficacy of laser versus cryotherapy on the treatment of warts

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: March 2016
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Warts

Intervention

Other:
• Cryotherapy
up to a maximum of four treatments every 21-28 days
• laser
up to a maximum of four treatments every 21-28 days

Locations

Country	Name	City	State
China	The 306 Hospital of PLA	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
The 306 Hospital of People's Liberation Army	Peking University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	effective rate	Effective assessment is performed by a senior dermatologist.	Effective rate will be calculated at 16 weeks from the first treatment
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	patient satisfaction	on a five-point scale, from 'very satisfied' to 'very satisfied'	Patient satisfactionwill be assessed within 3-4 weeks after each treatment
Secondary	treatment costs	record the cost after each treatment	Treatment costs will be recorded within 10 minutes after each treatment
Secondary	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