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 : July 30, 2020
|Condition or disease||Intervention/treatment||Phase|
|Basal Cell Nevus Syndrome||Drug: Levulan Other: Red Light PDT Other: Blue Light PDT||Not Applicable|
This is a pilot intra-patient comparative study to evaluate the ability of cyclic Photodynamic Therapy (PDT) using Red (635 nm) or Blue (400 nm) light with 5-Aminolevulinic acid, to eliminate BCC skin cancers that occur in patients with Basal Cell Nevus Syndrome (Gorlin-Goltz Syndrome).
Patients will receive 3 cycles of Red light and Blue light PDT treatments, for a total of 6 treatments, over a 4 month period. Cycles will be spaced 2 months apart. Each cycle consists of a double course of PDT treatment with treatments spaced one week apart. Every subject will be treated with two light sources, blue and red, according to randomized assignments made to left side or right side of the body. There will be a final assessment visit at month 6.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||All patients received a different treatment to each half of their body. First Levulan with red light PDT (to tumors on one side of the body), and then Levulan with blue light PDT (to tumors on the other side of the body), at six treatment visits.|
|Masking:||None (Open Label)|
|Official Title:||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|
|Actual Study Start Date :||February 1, 2016|
|Actual Primary Completion Date :||September 1, 2016|
|Actual Study Completion Date :||December 1, 2016|
Experimental: Red Light PDT and Blue Light PDT
The tumor clearance with one side treated with Levulan and Red light PDT, and the contralateral side treated with Blue light PDT.
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
- Tumor Clearance Rate Following Red or Blue Light PDT [ Time Frame: 6 months ]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 (bilateral intrapatient comparison).
- Pain During Illumination [ Time Frame: Maximum value reported during the illumination period ]Pain reported by the patient, using a 0-10 Visual Analog Scale (VAS), where 0 is no pain and 10 is maximum pain possible.
- Patient Satisfaction Survey [ Time Frame: 6 months ]
Overall patient satisfaction with the technique will be assessed using a simple survey:
6 = extremely satisfied; 5 = very satisfied; 4 = somewhat satisfied; 3 = somewhat dissatisfied; 2 = very dissatisfied; 1 = extremely dissatisfied.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02157623
|United States, Ohio|
|Cleveland, Ohio, United States, 44195|
|Principal Investigator:||Edward V. Maytin, MD, PhD||The Cleveland Clinic|