Efficacy of Laser Versus Cryotherapy in the Treatment of Warts
Study Details
Study Description
Brief Summary
The purpose of this study is to test the efficacy of laser versus cryotherapy on the treatment of warts
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- 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
- 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.
- 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
- 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
Eligibility Criteria
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.
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Patients who have local hypoesthesia .
-
Patients who can not tolerate cryotherapy or laser treatment for their own reasons.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The 306 Hospital of PLA | Beijing | China | 100101 |
Sponsors and Collaborators
- The 306 Hospital of People's Liberation Army
- Peking University
Investigators
- Principal Investigator: Shichao Lu, MD, Dermatology Deparment of the 306 Hospital of PLA
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 306PLA-001