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

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ClinicalTrials.gov Identifier: NCT02157623
Recruitment Status : Completed
First Posted : June 6, 2014
Results First Posted : June 2, 2017
Last Update Posted : June 2, 2017
Sponsor:
Collaborator:
DUSA Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Edward Maytin, MD, PhD, The Cleveland Clinic

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Basal Cell Nevus Syndrome
Interventions Drug: Levulan
Other: Red Light Photodynamic Therapy
Other: Blue Light Photodynamic Therapy
Enrollment 7
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Red Light Photodynamic Therapy Blue Light Photodynamic Therapy
Hide Arm/Group Description

Subject will be randomized to right or left side and assigned side will be treated with red light PDT after Levulan application

Levulan: Levulan application followed by Red or Blue light PDT on randomized treatment fields

Red Light Photodynamic Therapy: Aktilite™ (red lamp) after Levulan application on randomized treatment field

Subject will be randomized to right or left side and assigned side will be treated with blue light PDT after Levulan application

Levulan: Levulan application followed by Red or Blue light PDT on randomized treatment fields

Blue Light Photodynamic Therapy: Blu-U® (blue lamp) after Levulan application on randomized treatment field

Period Title: Overall Study
Started 4 3
Completed 0 0
Not Completed 4 3
Reason Not Completed
Physician Decision             4             3
Arm/Group Title Red Light Photodynamic Therapy Blue Light Photodynamic Therapy Total
Hide Arm/Group Description

Subject will be randomized to right or left side and assigned side will be treated with red light PDT after Levulan application

Levulan: Levulan application followed by Red or Blue light PDT on randomized treatment fields

Red Light Photodynamic Therapy: Aktilite™ (red lamp) after Levulan application on randomized treatment field

Subject will be randomized to right or left side and assigned side will be treated with blue light PDT after Levulan application

Levulan: Levulan application followed by Red or Blue light PDT on randomized treatment fields

Blue Light Photodynamic Therapy: Blu-U® (blue lamp) after Levulan application on randomized treatment field

Total of all reporting groups
Overall Number of Baseline Participants 0 0 0
Hide Baseline Analysis Population Description
study was terminated, no data
Age, Categorical  
Number Analyzed 0 participants 0 participants 0 participants
<=18 years 0 0 0
Between 18 and 65 years 0 0 0
>=65 years 0 0 0
Sex: Female, Male  
Number Analyzed 0 participants 0 participants 0 participants
Female 0
Male 0
Region of Enrollment  
Unit of measure:  Participants
United States Number Analyzed 0 participants 0 participants 0 participants
1.Primary Outcome
Title Tumor Clearance Rate
Hide Description The rate of clearance of existing BCC tumors will be assessed in patients with BCNS, using clinical and photographic measurements. The endpoint will be assessed for tumors in a Red light treatment field and a Blue light treatment field in each patient, and compared.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
study terminated, no outcomes
Arm/Group Title Red Light Photodynamic Therapy Blue Light Photodynamic Therapy
Hide Arm/Group Description:

Subject will be randomized to right or left side and assigned side will be treated with red light PDT after Levulan application

Levulan: Levulan application followed by Red or Blue light PDT on randomized treatment fields

Red Light Photodynamic Therapy: Aktilite™ (red lamp) after Levulan application on randomized treatment field

Subject will be randomized to right or left side and assigned side will be treated with blue light PDT after Levulan application

Levulan: Levulan application followed by Red or Blue light PDT on randomized treatment fields

Blue Light Photodynamic Therapy: Blu-U® (blue lamp) after Levulan application on randomized treatment field

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Pain Score on a Visual-Analog Scale
Hide Description Tolerability, defined as pain during treatment using Red light versus Blue light PDT, will be assessed.
Time Frame 6 months
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Patient Satisfaction Survey
Hide Description Overall patient satisfaction with the technique will be assessed using a simple survey.
Time Frame 6 months
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Red Light Photodynamic Therapy Blue Light Photodynamic Therapy
Hide Arm/Group Description

Subject will be randomized to right or left side and assigned side will be treated with red light PDT after Levulan application

Levulan: Levulan application followed by Red or Blue light PDT on randomized treatment fields

Red Light Photodynamic Therapy: Aktilite™ (red lamp) after Levulan application on randomized treatment field

Subject will be randomized to right or left side and assigned side will be treated with blue light PDT after Levulan application

Levulan: Levulan application followed by Red or Blue light PDT on randomized treatment fields

Blue Light Photodynamic Therapy: Blu-U® (blue lamp) after Levulan application on randomized treatment field

All-Cause Mortality
Red Light Photodynamic Therapy Blue Light Photodynamic Therapy
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Red Light Photodynamic Therapy Blue Light Photodynamic Therapy
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Red Light Photodynamic Therapy Blue Light Photodynamic Therapy
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Edward Maytin, MD, PhD
Organization: Cleveland Clinic
Phone: 216-445-6676
EMail: maytine@ccf.org
Layout table for additonal information
Responsible Party: Edward Maytin, MD, PhD, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT02157623     History of Changes
Obsolete Identifiers: NCT02258243
Other Study ID Numbers: CASE 2614
First Submitted: June 2, 2014
First Posted: June 6, 2014
Results First Submitted: May 1, 2017
Results First Posted: June 2, 2017
Last Update Posted: June 2, 2017