Superficial Basal Cell Carcinoma Clinical Trial
— BCCOfficial title:
Randomized Pilot Study of Treatment for Basal Cell Carcinoma Using the Multiplex 595/1064 nm Laser
NCT number | NCT02270645 |
Other study ID # | 20120815 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | October 2014 |
Est. completion date | November 2017 |
Verified date | October 2018 |
Source | University of Miami |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 pilot study, we will preliminarily assess the efficacy and safety of the 595/1064 nm
Multiplex laser when treating superficial and nodular basal cell carcinomas less than 1.5 cm
in size. This is an unblinded study in which patients will be randomized to either a
treatment arm or a control arm. Patients in the treatment arm will receive three treatments
with the 595/1064 nm multiplex laser spaced four weeks apart. The control group will visit
the clinic with the same schedule as the treatment group for monitoring of the lesion. All
patients will return one month after last treatment session or clinical visit, for evaluation
of clinical and histological clearance.
Status | Completed |
Enrollment | 12 |
Est. completion date | November 2017 |
Est. primary completion date | June 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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) |
Country | Name | City | State |
---|---|---|---|
United States | University of Miami Hospital and Clinics/Sylvester Comprehensive Cancer Center | Miami | Florida |
Lead Sponsor | Collaborator |
---|---|
University of Miami |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of Lesions Cleared Histologically | Number of lesions cleared clinically and histologically. The lesion clearance was determined by measuring the size of lesion which also included a histological evaluation 4 weeks after the treatment. | 91 days | |
Secondary | Number of Adverse Events Reported | Adverse events reported by participants | 91 days |
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