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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01808443
Other study ID # 306PLA-001
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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