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

NCT02270645 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2018-10-02

Study results available
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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 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.

Conditions

  • Nodular Basal Cell Carcinoma
  • Superficial Basal Cell Carcinoma

Interventions

DEVICE

595/1064 multiplex laser

595/1064 multiplex laser will be used 3 times spaced by a four week interval (+/- 3 days), it will be administered in an outpatient clinic setting.

Sponsors & Collaborators

  • University of Miami

    lead OTHER

Principal Investigators

  • Keyvan Nouri, MD · University of Miami Silvester Comprenhensive Care Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2017-06-30
Completion
2017-11-30

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02270645 on ClinicalTrials.gov