Long-pulsed 1064 nm Nd:YAG Laser Treatment of Basal Cell Carcinoma

Completed · Not applicable

Conditions studied: Basal Cell Carcinoma

In brief

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.

Key facts

Study ID

NCT02662244

Run by

University of California, San Diego

People needed

33

Starts

2015-09-01

Expected to finish

2016-09-01

Last updated by the study team

2019-09-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of California San Diego — San Diego, California, United States

Full record on ClinicalTrials.gov

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