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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02157623
Recruitment Status : Completed
First Posted : June 6, 2014
Results First Posted : June 2, 2017
Last Update Posted : July 30, 2020
Sponsor:
Collaborator:
DUSA Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Edward Maytin, MD, PhD, The Cleveland Clinic

Brief 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.

Condition or disease Intervention/treatment Phase
Basal Cell Nevus Syndrome Drug: Levulan Other: Red Light PDT Other: Blue Light PDT Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: N/A
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)
Primary Purpose: Treatment
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


Arm Intervention/treatment
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.
Drug: Levulan
Levulan application followed by Red or Blue light PDT
Other Names:
  • Levulan™
  • Levulan® Kerastick® for Topical Solution
  • 5-aminolevulinic acid
  • aminolevulinic acid HCL
  • ALA

Other: Red Light PDT
Aktilite™ (red lamp) after Levulan application on lesions
Other Names:
  • Aktilite™
  • Red Lamp
  • Red Light
  • PDT

Other: Blue Light PDT
Blu-U® (blue lamp) after Levulan application on lesions
Other Names:
  • Blu-U
  • Blue Lamp
  • Blue Light
  • PDT




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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.

  2. 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.




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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men, women, and children of any age or ethnic group who meet eligibility
  • Patients under 18 years of age must be accompanied and co-consented, by a parent or legal guardian.
  • Patients must have a diagnosis of Basal Cell Nevus Syndrome (BCNS)
  • For diagnosis of BCNS, the patient must have either 2 major criteria, one major and two minor criteria, or one major criterion plus molecular confirmation of a PTCH1 gene mutation
  • Major criteria are:

    • (1) BCC prior to age 20 years, or excessive number of BCCs out of proportion to prior sun exposure and skin type
    • (2) keratocyst of the jaw prior to age 20
    • (3) palmar or plantar pitting
    • (4) lamellar calcification of the falx cerebri
    • (5) medulloblastoma
    • (6) first degree relative with BCNS
  • Minor criteria are:

    • (1) rib anomalies, or other specific skeletal malformations including kyphoscoliosis and short 4th metacarpals
    • (2) macrocephaly
    • (3) cleft/lip or palate;
    • (4) fibroma of the heart or ovary
    • (5) ocular abnormalities
    • (6) other rare abnormalities
  • At least two BCC tumors, preferably more, located in different body regions or located greater than 10 cm apart in locations that can be reproducibly separated into red and blue illumination fields
  • Female subjects are not pregnant or nursing or planning to become pregnant during the study
  • Subjects must have the ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

  • Pregnant, planning on getting pregnant or nursing
  • Currently participating in another clinical trial
  • Using any topical treatment for their BCC tumors, unless discontinued at least 1 month prior
  • Currently being treated for other cancers with medical or radiation therapy
  • Patients with a known hypersensitivity to 5-aminolevulinic acid or any component of the study material
  • Patients with a history of a photosensitivity disease, including porphyria cutanea tarda

Information from the National Library of Medicine

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


Locations
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United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
Edward Maytin, MD, PhD
DUSA Pharmaceuticals, Inc.
Investigators
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Principal Investigator: Edward V. Maytin, MD, PhD The Cleveland Clinic
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Responsible Party: Edward Maytin, MD, PhD, Staff, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT02157623    
Obsolete Identifiers: NCT02258243
Other Study ID Numbers: CASE 2614
First Posted: June 6, 2014    Key Record Dates
Results First Posted: June 2, 2017
Last Update Posted: July 30, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Edward Maytin, MD, PhD, The Cleveland Clinic:
Basal Cell Nevus Syndrome
Gorlin's Syndrome
Additional relevant MeSH terms:
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Nevus
Nevus, Pigmented
Basal Cell Nevus Syndrome
Syndrome
Disease
Pathologic Processes
Nevi and Melanomas
Neoplasms by Histologic Type
Neoplasms
Odontogenic Cysts
Jaw Cysts
Bone Cysts
Cysts
Carcinoma, Basal Cell
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms, Basal Cell
Neoplastic Syndromes, Hereditary
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Jaw Diseases
Stomatognathic Diseases
Abnormalities, Multiple
Congenital Abnormalities
Genetic Diseases, Inborn
Aminolevulinic Acid
Photosensitizing Agents
Dermatologic Agents