Long-pulsed 1064 nm Nd:YAG Laser Treatment of Basal Cell Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 2
- 主要终点
- This is a Study to Measure the Efficacy of the Nd:YAG Laser to Cause Complete Regression of Basal Cell Carcinoma.
研究概览
简要总结
Basal cell carcinoma (BCC) is the most common skin cancer worldwide. Although this tumor is rarely life threatening, it is locally destructive and can cause significant cosmetic and functional problems. Standard therapeutic modalities for BCC often result in disfigurement from surgical treatments and recurrences with topical therapies. Thus, there is a need for alternative non-surgical options that are effective, efficient, and have a low risk of side effects. This has led to the emergence of laser investigations for the treatment of BCC due to the ease of treatment, lack of significant downtime, decreased risk of complications, and absence of a surgical scar. The primary objective of this study is to evaluate the safety and efficacy of laser treatment of subjects with BCC on the trunk and extremities. Subjects will receive one treatment with the laser to the BCC. Standard excision will be performed between 30 and 90 days after laser treatment to evaluate resolution of the BCC. A visit for suture removal will be performed as appropriate for the site of the surgery. Standardized photographs and measurements will be taken at the baseline visit, immediately after laser treatment and on the day of excision.
详细描述
Study visits and parameters to be measured
All visits in this study will be performed at the University of California, San Diego Dermatology Clinic, 3rd floor, 8899 University Center Ln., San Diego, California 92109.
Baseline Visit and Laser exposures (Visit 1)
This visit is expected to take approximately 1 hour. The following describes the procedures performed at this visit.
- Prior to any screening assessments, informed consent will be obtained by the investigator. When the subject fully understands the nature of the study and its risks, the subject will be asked to sign and date the informed consent form. The investigator will then sign and date the form.
- A detailed medical history of information pertaining to treatment will be obtained.
- The subject will be examined to determine if he or she meets the study criteria.
- If the subject meets the criteria for the study, the subject will be assigned the next consecutive subject number.
- Females of childbearing age will undergo a urine pregnancy test
- Clean skin within the test sites with alcohol and shave hair with disposable shavers (if hairs are present within the test areas)
- The lesions to be treated will be identified and marked. A record of the location of the lesion will be made. Marking will be done to include the tumor and a 4mm margin of normal skin using a surgical marking pen.
- The treatment area will be photographed. Emphasis will be place on keeping the ambient lighting, facial expression and camera angles exactly the same for each scheduled photograph during the study. In addition, effort will be made to include anatomic landmarks.
- The tumor will be irradiated with appropriate overlapping laser pulses with a 5-7 mm spot from the laser with the 1064nm laser with energy settings determined to be appropriate by the study investigator as described above. A 4 mm margin zone will be included.
- The treatment area will be photographed again.
- The treatment area will be assessed for side effects using the following scale:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Biopsy-proven basal cell carcinoma of any non-aggressive subtype less than 2 cm located on the trunk (chest, abdomen, back) or extremities (arms, legs), with clearly visible margins, suitable for treatment by standard surgical excision.
- •Age greater than 18 years.
- •Able to read and comprehend the informed consent form.
- •Informed consent form signed by the subject.
- •Willingness to follow the treatment schedule and post treatment care requirement.
排除标准
- •Lesion to be treated is on the face, areola, hands, feet, ankles, pretibial surface or genitalia.
- •BCC with aggressive features including morpheaform/fibrosing/sclerosing, infiltrating, perineural, metatypical/keratotic, micronodular, or basosquamous subtypes.
- •Any BCC lesion that falls under Mohs Micrographic Surgery Appropriate Use Criteria for lesions on the trunk or extremities including recurrent lesions, aggressive subtypes, tumors > 2 cm, lesions on the hands, feet, ankles, genitalia, and pretibial surface)
- •Confluent carcinomatosis in which collision lesions are likely and tumor borders are difficult to ascertain.
- •Scarring or infection of the area to be treated
- •Subject is pregnant.
- •Subject is immunocompromised. Immunocompromised is defined by any condition, process or medication that causes the immune system to be attenuated. (ie. HIV, immunosuppressive medications, active systemic malignancies, organ transplant recipients, etc).
- •Subjects with Gorlin's syndrome (Basal Cell Nevus Syndrome) or other syndrome that increases the risk of confluent carcinomatosis
- •Subjects may not be on any blood thinners, including but not limited to warfarin or clopidogrel (NOT including aspirin).
- •Prisoners and decisionally impaired subjects.
- •Current or history of psychiatric disease, or substance abuse that would interfere with ability to comply with the study protocol or give informed consent.
研究组 & 干预措施
Yag Laser Treatment Of Basal Cell Carcinoma
Study participants will be treated with long-pulsed 1064 nm Nd:YAG laser at the investigator's discretion based on the clinical endpoint (slight contraction and greying of the skin surface), the tumor characteristics, and the patient's skin phototype.
干预措施: Nd:YAG laser (Device)
结局指标
主要结局
This is a Study to Measure the Efficacy of the Nd:YAG Laser to Cause Complete Regression of Basal Cell Carcinoma.
时间窗: The primary outcome of the study is histologic clearance of BCC tumor 30 days
The primary outcome data collected during the study will include: * Number of tumors that showed histologic complete regression.
次要结局
- • Clinical and Photographic Evidence of Extent of Purpura After Each Treatment(30 days)
- Clinical and Photographic Evidence of Extent of Erythema Occurring After Each Treatment(30 days)
- Clinical and Photographic Evidence of Extent of Blistering Occurring After Each Treatment(30 days)
- • Clinical and Photographic Evidence of Extent of Edema Occurring After Each Treatment(30 days)
研究者
Arisa Ortiz
Director, Laser and Cosmetic Dermatology
University of California, San Diego