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

NCT02662244 | Completed Results

• 1 other identifier: 160062
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Basal Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• This is a Study to Measure the Efficacy of the Nd:YAG Laser to Cause Complete Regression of Basal Cell Carcinoma.

  The primary outcome data collected during the study will include: * Number of tumors that showed histologic complete regression.

  The primary outcome of the study is histologic clearance of BCC tumor 30 days

Secondary Outcomes (4)

• • Clinical and Photographic Evidence of Extent of Purpura After Each Treatment

  30 days

• • Clinical and Photographic Evidence of Extent of Edema Occurring 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

Study Arms (1)

Yag Laser Treatment Of Basal Cell Carcinoma

EXPERIMENTAL

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.

Device: Nd:YAG laser

Interventions

Nd:YAG laser DEVICE

Long-Pulsed 1064 NM ND:Yag Laser Treatment Of Basal Cell Carcinoma

Yag Laser Treatment Of Basal Cell Carcinoma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• University of California, San Diego: lead
• Massachusetts General Hospital: collaborator

Study Sites (1)

University of California San Diego

San Diego, California, 92122, United States

Location

MeSH Terms

Conditions

Carcinoma, Basal Cell

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Basal Cell

Results Point of Contact

• Title: Dr. Arisa Ortiz
• Organization: UCSD

dermstudies@ucsd.edu

858-657-1697

Study Officials

• Arisa Ortiz, MD

  UCSD

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Laser and Cosmetic Dermatology

Study Record Dates

• First Submitted: January 25, 2015
• First Posted: January 25, 2016
• Study Start: September 1, 2015
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: September 6, 2019
• Results First Posted: September 6, 2019

Record last verified: 2019-09

Locations

US (1)