Status:
COMPLETED
Randomized Pilot Study of Treatment for BCC Using the Multiplex 595/1064 nm Laser
Lead Sponsor:
University of Miami
Conditions:
Nodular Basal Cell Carcinoma
Superficial Basal Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Laser therapy for basal cell carcinoma may be a superior option for patients who do not wish to or cannot tolerate other treatment modalities such as topical chemotherapeutics or surgery. In this pil...
Detailed Description
Basal cell carcinoma is a malignancy with significant prevalence that rarely metastasizes but can be locally destructive. Laser therapy for this type of lesion may be a superior option for patients wh...
Eligibility Criteria
Inclusion
- Adults age 18 years or older
- Diagnostic biopsy must be no later than three months prior to enrollment
- Lesion is biopsy-proven nodular or superficial BCC
- BCC is 1.5 cm or less in diameter
- BCC is on trunk or extremities
- Fitzpatrick skin types I, II, III, or IV
- If female, must no longer be of child-bearing potential
- Ability to understand and the willingness to sign a written informed consent document
Exclusion
- BCC is greater than 1.5 cm in size
- If location of BCC is on the face.
- Patients whose biopsy shows a subtype other than superficial or nodular, or has characteristics of a more aggressive nature, such as: Basosquamous basal cell carcinoma, Morpheaform/ infiltrative basal cell carcinoma, Sclerosing basal cell carcinoma, Recurrent basal cell carcinomas
- Patients who may not be able to tolerate light therapy, such as: Patients with seizure disorders triggered by light, Patients who have or are currently receiving gold therapy, Patients with any light sensitive disorder, Patients taking medication that increases sensitivity to light, Patients with Systemic Lupus Erythematous
- Fitzpatrick skin types V or VI
- Patients who are taking certain oral medications such as: Anticoagulants except for aspirin 81 mg, Isotretinoin (currently or within last 6 months), Medications that alter wound healing
- Patients who have a history of Herpes Simplex Virus outbreak in the area to be treated
- Patients whose lesion has been previously, or is currently being, treated by another modality (topical immunomodulators/ chemotherapeutics, cryotherapy, curettage and electrodesiccation, surgical excision, or Mohs micrographic surgery)
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2017
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT02270645
Start Date
October 1 2014
End Date
November 1 2017
Last Update
October 2 2018
Active Locations (1)
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1
University of Miami Hospital and Clinics/Sylvester Comprehensive Cancer Center
Miami, Florida, United States, 33136