Randomized Double Blind Study Comparing Liquid Nitrogen Cryotherapy With Nd:YAG in the Treatment of Verruca Vulgaris
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Wart clearance
研究概览
简要总结
Verruca vulgaris (VV), or the common wart, is a relatively prevalent and often frustrating cutaneous disease to treat. A single, highly effective therapy for the treatment of VV has not been found. Liquid nitrogen is considered the standard of care for VV and studies report a 44% to 47% cure rate. In search of more efficacious and convenient therapeutic options, a variety of lasers have been reported in the treatment of VV including the Nd:YAG laser (1064nm). Lasers offer the potential for decreased treatment associated pain, fewer office visits, higher cure rates and lower recurrence rates. However, many of the available published studies draw conclusions from case reports and small case series without any randomized controlled trials. A randomized, controlled study is needed to evaluate the efficacy of the microsecond Nd:YAG (1064nm) compared to conventional cryotherapy.
This study will use the Cutera CoolGlide Nd:YAG laser that operates in the infrared spectrum at a wavelength of 1064nm. This a single site, double blind, randomized controlled clinical trial to evaluate the efficacy of the Nd:YAG laser (Cutera) in the treatment of verruca vulgaris of the hands and feet versus conventional liquid nitrogen therapy.
The investigators hypothesize that there will be a significantly higher number of warts with complete resolution at 4 months follow-up in the Nd:YAG treated group versus the liquid nitrogen therapy group. The investigators also hypothesize that there will be a faster time to complete resolution of the verruca in the Nd:YAG treated group versus the liquid nitrogen treated group.
详细描述
Outcome measures: The primary outcome will be complete resolution of the lesion defined as: clinical absence of verruca vulgaris with redevelopment of skin lines on the dorsal surface and dermatoglyphics (ridges of the skin) on the inner surface of the palms and feet, as determined by a blinded clinician investigator blinded to the treatment will evaluate each lesion and determine whether the lesion. A secondary outcome will include: time to complete resolution of the lesion.
2. Objectives and Specific Aims 1.1. Primary objective: To evaluate the efficacy of the Cutera CoolGlide 1064nm Nd:YAG laser in the treatment of verruca vulgaris of the hands and feet versus conventional therapy with liquid nitrogen cryotherapy.
2. Research Design and Methods This a single site double blind (faculty observer and patient blinded; operator/clinician non-blinded), randomized controlled clinical trial to evaluate the efficacy of the Nd:YAG laser (Cutera) in the treatment of verruca vulgaris of the hands and feet versus conventional therapy with liquid nitrogen in 52 patients.
2.2 Study Procedures Informed consent A signed informed consent form will be obtained from each patient prior to entering the study
Physical examination A brief physical examination of the skin including the affected area will be performed. Photographs will be taken of affected areas, prior to and after each treatment from baseline through the fifth treatment follow-up. The investigator will document the number, size and location of each lesion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Using sealed envelope assignment, the participant will be placed in study Arm 1 or 2. The investigator will not be masked because the investigator will administer the standard of care cryotherapy or the experimental laser treatment. The outcome assessor will be masked to study group assignment for gathering data from trial participants.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult males or females, ages 18 - 75
- •Fitzpatrick skin types 1-6
- •Patient is able to read and understand English and will give written informed consent to participate.
- •Patient elects to undergo laser therapy or conventional therapy with liquid nitrogen for the treatment of verruca vulgaris.
- •Clinical evidence of at least one verruca vulgaris, but no more than ten that have not received treatment for at least one month prior to their study start date.
- •Warts to be treated will be located only on the hands or the feet.
排除标准
- •Less than 18 years of age or greater than 75 years of age.
- •Non-English speaking people, who cannot read, understand and sign the consent.
- •Pregnant females.
- •Any form of prior treatment to the area within the last 1 month.
- •Immunosuppressed patients including patients with internal malignancy, on immunosuppressive drugs (including oral steroids), HIV positive or history of connective tissue disease (ie. SLE, DM, Scleroderma).
- •Patients undergoing light therapy including NBUVB, PUVA, high UVB will be excluded from the study until their treatment is complete.
- •Allergy to any components of the topical lidocaine (LMX, 4% lidocaine).
结局指标
主要结局
Wart clearance
时间窗: ~ 6 months
Patients are treated with either arm of the study every 2 weeks for a total of 10 weeks (5 treatments) or until their warts clear. Patients whose warts clear are then followed up at 1 month and 2 months in person and then at 4 months by phone.
次要结局
- Time to clearance(~6 months)