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Trial record 2 of 32 for:    "Nevoid basal cell carcinoma syndrome"

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 : June 2, 2017
Sponsor:
Collaborator:
DUSA Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Edward Maytin, MD, PhD, The Cleveland Clinic

Tracking Information
First Submitted Date  ICMJE June 2, 2014
First Posted Date  ICMJE June 6, 2014
Results First Submitted Date  ICMJE May 1, 2017
Results First Posted Date  ICMJE June 2, 2017
Last Update Posted Date June 2, 2017
Actual Study Start Date  ICMJE February 1, 2016
Actual Primary Completion Date September 1, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 4, 2014)
Tumor Clearance Rate [ 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02157623 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 4, 2014)
  • Pain Score on a Visual-Analog Scale [ Time Frame: 6 months ]
    Tolerability, defined as pain during treatment using Red light versus Blue light PDT, will be assessed.
  • Patient Satisfaction Survey [ Time Frame: 6 months ]
    Overall patient satisfaction with the technique will be assessed using a simple survey.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Blue vs Red Light During Levulan Based Photodynamic Therapy in Patients With Basal Cell Nevus Syndrome
Official Title  ICMJE 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
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Basal Cell Nevus Syndrome
Intervention  ICMJE
  • Drug: Levulan
    Levulan application followed by Red or Blue light PDT on randomized treatment fields
    Other Names:
    • Levulan™
    • Levulan® Kerastick® for Topical Solution
    • 5-aminolevulinic acid
    • aminolevulinic acid HCL
    • ALA
  • Other: Red Light Photodynamic Therapy
    Aktilite™ (red lamp) after Levulan application on randomized treatment field
    Other Names:
    • Aktilite™
    • Red Lamp
    • Red Light
    • PDT
  • Other: Blue Light Photodynamic Therapy
    Blu-U® (blue lamp) after Levulan application on randomized treatment field
    Other Names:
    • Blu-U
    • Blue Lamp
    • Blue Light
    • PDT
Study Arms  ICMJE
  • Active Comparator: Red Light Photodynamic Therapy
    Subject will be randomized to right or left side and assigned side will be treated with red light PDT after Levulan application
    Interventions:
    • Drug: Levulan
    • Other: Red Light Photodynamic Therapy
  • Active Comparator: Blue Light Photodynamic Therapy
    Subject will be randomized to right or left side and assigned side will be treated with blue light PDT after Levulan application
    Interventions:
    • Drug: Levulan
    • Other: Blue Light Photodynamic Therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 1, 2017)
7
Original Estimated Enrollment  ICMJE
 (submitted: June 4, 2014)
3
Actual Study Completion Date  ICMJE December 1, 2016
Actual Primary Completion Date September 1, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02157623
Other Study ID Numbers  ICMJE CASE 2614
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Edward Maytin, MD, PhD, The Cleveland Clinic
Study Sponsor  ICMJE Edward Maytin, MD, PhD
Collaborators  ICMJE DUSA Pharmaceuticals, Inc.
Investigators  ICMJE
Principal Investigator: Edward V. Maytin, MD, PhD The Cleveland Clinic
PRS Account The Cleveland Clinic
Verification Date May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP