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Blue vs Red Light During Levulan Based Photodynamic Therapy in Patients With Basal Cell Nevus Syndrome

NCT02157623 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2020-07-30

Study results available
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Summary

The investigators will be testing whether aminolevulinate-based (Levulan™) Photodynamic Therapy (PDT) shows effectiveness in the treatment and prevention of cutaneous basal cell carcinoma (BCC) in Basal Cell Nevus Syndrome (BCNS) patients. Levulan™ PDT is an FDA-approved method widely used currently for squamous precancers of the skin. The investigators hypothesize that PDT will provide exceptional benefit in the BCNS population because PDT is nonmutagenic, nonscarring, and can be safely repeated many times. Additionally, the study will investigate whether there are any differences in tumor clearance between the Blu-U® (blue lamp) and Aktilite™(red lamp) therapies.

Conditions

  • Basal Cell Nevus Syndrome

Interventions

DRUG

Levulan

Levulan application followed by Red or Blue light PDT

OTHER

Red Light PDT

Aktilite™ (red lamp) after Levulan application on lesions

OTHER

Blue Light PDT

Blu-U® (blue lamp) after Levulan application on lesions

Sponsors & Collaborators

  • DUSA Pharmaceuticals, Inc.

    collaborator INDUSTRY

  • Edward Maytin, MD, PhD

    lead OTHER

Principal Investigators

  • Edward V. Maytin, MD, PhD · The Cleveland Clinic

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-01
Primary Completion
2016-09-01
Completion
2016-12-01

Countries

  • United States

Study Locations

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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 NCT02157623 on ClinicalTrials.gov