CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 3 enrolled
Drug / intervention
Levulan +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02157623
NCT02157623N/ACompleted
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Pilot Trial Comparing Two Different Wavelengths of Light (Blue Versus Red) During Levulan™-Based Photodynamic Therapy of Basal Cell Carcinoma in Patients With Basal Cell Nevus Syndrome

Edward Maytin, MD, PhD·interventional·Posted Jun 6, 2014·Updated Jul 30, 2020

In Brief

A clinical study evaluating Levulan, Red Light PDT, and 1 other intervention for Basal Cell Nevus Syndrome. Completed, enrolled 3 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBasal Cell Nevus Syndrome
CountriesUnited States
CollaboratorsDUSA Pharmaceuticals, Inc.

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedJun 6, 2014
Enrollment StartFeb 1, 2016
Primary CompletionSep 1, 2016
Study CompletionDec 1, 2016
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 12.1 years ago

Interventions

Levulandrug

Levulan application followed by Red or Blue light PDT

Red Light PDTother

Aktilite™ (red lamp) after Levulan application on lesions

Blue Light PDTother

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