Randomized Pilot Study of Treatment for BCC Using the Multiplex 595/1064 nm Laser

Completed · Not applicable

Conditions studied: Nodular Basal Cell Carcinoma, Superficial Basal Cell Carcinoma

In brief

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.

Key facts

Study ID

NCT02270645

Run by

University of Miami

People needed

12

Starts

2014-10-01

Expected to finish

2017-11-01

Last updated by the study team

2018-10-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• University of Miami Hospital and Clinics/Sylvester Comprehensive Cancer Center — Miami, Florida, United States

Full record on ClinicalTrials.gov

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