Clinical trial NCT01808443: 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
Overall status: COMPLETED
Phase: NA
Conditions: Warts
Keywords: cryotherapy
laser
cutaneous warts
Lead sponsor: The 306 Hospital of People's Liberation Army
Sponsor class: OTHER
Collaborators: name: Peking University
First posted: 2013-03-11
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: cure rate
timeFrame: Cure rate will be calculated at 16 weeks and 6 months from the first treatment
Secondary outcomes:
measure: effective rate
timeFrame: Effective rate will be calculated at 16 weeks from the first treatment
measure: recurrence rate
timeFrame: Recurrence rate will be calculated at 12 months from the first treatment
measure: average cure days
timeFrame: Average cure days will be calculated at 6 months from the first treatment
measure: side effects
timeFrame: Side effects will be assessed within 3-4 weeks after each treatment
measure: pain intensity
timeFrame: Pain intensity will be assessed within 3-4 weeks after each treatment
measure: patient satisfaction
timeFrame: Patient satisfactionwill be assessed within 3-4 weeks after each treatment
measure: treatment costs
timeFrame: Treatment costs will be recorded within 10 minutes after each treatment
measure: relationship between HPV type and curative effect
timeFrame: Relationship between HPV type and curative effect will be analyzed at 16 weeks and 6 months from the first treatment
Other outcomes:
Locations:
city: Beijing
country: China
facility: The 306 Hospital of PLA
Study officials:
affiliation: Dermatology Deparment of the 306 Hospital of PLA
name: Shichao Lu, MD
role: PRINCIPAL_INVESTIGATOR
References: