Clinical Trial: Long-pulsed 1064 nm Nd:YAG Laser Treatment of Basal Cell Carcinoma
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Long-pulsed 1064 nm Nd:YAG Laser Treatment of Basal Cell Carcinoma
Brief Summary: 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.
Detailed Summary:
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 camer
Sponsor: University of California, San Diego
Current Primary Outcome: This is a study to measure the efficacy of the Nd:YAG laser to cause complete regression of basal cell carcinoma. [ Time Frame: The primary outcome of the study is histologic clearance of BCC tumor 30 to 90 days ]
The primary outcome data collected during the study will include:
- Histologic complete regression of tumor
Original Primary Outcome: Same as current
Current Secondary Outcome: This is a study to measure the efficacy of the Nd:YAG laser to cause complete regression of basal cell carcinoma. [ Time Frame: 30-90 days ]
Secondary outcome data scores and measurements will include
- Clinical and photographic evidence of extent of side effects occurring after each treatment
- Clinical and photographic evidence of tumor regression
Original Secondary Outcome: Same as current
Information By: University of California, San Diego
Dates:
Date Received: January 25, 2015
Date Started: September 2015
Date Completion:
Last Updated: October 27, 2016
Last Verified: October 2016
