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| Name | Class |
|---|---|
| Peking University | OTHER |
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The purpose of this study is to test the efficacy of laser versus cryotherapy on the treatment of warts
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cryotherapy | Active Comparator | Cryotherapy, at most 4 times |
|
| laser | Experimental | laser, at most 4 times |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cryotherapy | Other | up to a maximum of four treatments every 21-28 days |
| |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shichao Lu, MD | Dermatology Deparment of the 306 Hospital of PLA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The 306 Hospital of PLA | Beijing | 100101 | China |
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| ID | Term |
|---|---|
| D014860 | Warts |
| ID | Term |
|---|---|
| D030361 | Papillomavirus Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D017679 | Cryotherapy |
| D007834 | Lasers |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
| D055618 | Radiation Equipment and Supplies |
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| laser |
| Other |
up to a maximum of four treatments every 21-28 days |
|
| 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 |
| D017193 |
| Skin Diseases, Viral |
| D014412 | Tumor Virus Infections |
| D012874 | Skin Diseases, Infectious |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |