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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02662244
Recruitment Status : Completed
First Posted : January 25, 2016
Results First Posted : September 6, 2019
Last Update Posted : September 6, 2019
Sponsor:
Collaborator:
Massachusetts General Hospital
Information provided by (Responsible Party):
Arisa Ortiz, University of California, San Diego

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.

Condition or disease Intervention/treatment Phase
Basal Cell Carcinoma Device: Nd:YAG laser Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Long-pulsed 1064 nm Nd:YAG Laser Treatment of Basal Cell Carcinoma
Study Start Date : September 2015
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016

Arm Intervention/treatment
Experimental: 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.
Device: Nd:YAG laser
Long-Pulsed 1064 NM ND:Yag Laser Treatment Of Basal Cell Carcinoma




Primary Outcome Measures :
  1. 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 days ]

    The primary outcome data collected during the study will include:

    • Number of tumors that showed histologic complete regression.


Secondary Outcome Measures :
  1. • Clinical and Photographic Evidence of Extent of Purpura After Each Treatment [ Time Frame: 30 days ]

    11. The treatment area will be assessed post laser and at the final evaluation visit for purpura using the following scale:

    • 0 = absence
    • 1 = mild
    • 2 = moderate
    • 3 = severe

  2. • Clinical and Photographic Evidence of Extent of Edema Occurring After Each Treatment [ Time Frame: 30 days ]

    3. The treatment area will be assessed for edema using the following scale:

    • 0 = absence
    • 1 = mild
    • 2 = moderate
    • 3 = severe

  3. Clinical and Photographic Evidence of Extent of Erythema Occurring After Each Treatment [ Time Frame: 30 days ]

    The treatment area will be assessed for erythema using the following scale:

    • 0 = absence
    • 1 = mild
    • 2 = moderate
    • 3 = severe

  4. Clinical and Photographic Evidence of Extent of Blistering Occurring After Each Treatment [ Time Frame: 30 days ]

    The treatment area will be assessed for blistering using the following scale:

    • 0 = absence
    • 1 = mild
    • 2 = moderate
    • 3 = severe



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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.
  2. Age greater than 18 years.
  3. Able to read and comprehend the informed consent form.
  4. Informed consent form signed by the subject.
  5. Willingness to follow the treatment schedule and post treatment care requirement.

Exclusion Criteria:

  1. Lesion to be treated is on the face, areola, hands, feet, ankles, pretibial surface or genitalia.
  2. BCC with aggressive features including morpheaform/fibrosing/sclerosing, infiltrating, perineural, metatypical/keratotic, micronodular, or basosquamous subtypes.
  3. 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)
  4. Confluent carcinomatosis in which collision lesions are likely and tumor borders are difficult to ascertain.
  5. Scarring or infection of the area to be treated
  6. Subject is pregnant.
  7. 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).
  8. Subjects with Gorlin's syndrome (Basal Cell Nevus Syndrome) or other syndrome that increases the risk of confluent carcinomatosis
  9. Subjects may not be on any blood thinners, including but not limited to warfarin or clopidogrel (NOT including aspirin).
  10. Prisoners and decisionally impaired subjects.
  11. Current or history of psychiatric disease, or substance abuse that would interfere with ability to comply with the study protocol or give informed consent.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02662244


Locations
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United States, California
University of California San Diego
San Diego, California, United States, 92122
Sponsors and Collaborators
University of California, San Diego
Massachusetts General Hospital
Investigators
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Principal Investigator: Arisa Ortiz, MD UCSD
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Responsible Party: Arisa Ortiz, Director, Laser and Cosmetic Dermatology, University of California, San Diego
ClinicalTrials.gov Identifier: NCT02662244    
Other Study ID Numbers: 160062
First Posted: January 25, 2016    Key Record Dates
Results First Posted: September 6, 2019
Last Update Posted: September 6, 2019
Last Verified: September 2019
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Basal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Basal Cell