N/A
N=33
Long-pulsed 1064 nm Nd:YAG Laser Treatment of Basal Cell Carcinoma
Basal Cell Carcinoma
Bottom Line
View on ClinicalTrials.gov: NCT02662244 ↗Enrolled (actual)
33
Serious AEs
0.0%
Results posted
Sep 2019
Primary outcome: Primary: This is a Study to Measure the Efficacy of the Nd:YAG Laser to Cause Complete Regression of Basal Cell Carcinoma. — 28 tumors
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Nd:YAG laser (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of California, San Diego
- Primary completion
- Sep 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY This is a Study to Measure the Efficacy of the Nd:YAG Laser to Cause Complete Regression of Basal Cell Carcinoma. |
28 | — |
| SECONDARY • Clinical and Photographic Evidence of Extent of Purpura After Each Treatment |
0.523809524; 0 | — |
| SECONDARY • Clinical and Photographic Evidence of Extent of Edema Occurring After Each Treatment |
1.428571429; 0 | — |
| SECONDARY Clinical and Photographic Evidence of Extent of Erythema Occurring After Each Treatment |
1.571428571; 1.095238095 | — |
| SECONDARY Clinical and Photographic Evidence of Extent of Blistering Occurring After Each Treatment |
1.19047619; 0.047619048 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT02662244). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.