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Trial record 2 of 8 for:    maytin

Protocols for Painless Photodynamic Therapy (PDT) of Actinic Keratoses

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ClinicalTrials.gov Identifier: NCT02124733
Recruitment Status : Recruiting
First Posted : April 28, 2014
Last Update Posted : April 12, 2019
Sponsor:
Information provided by (Responsible Party):
Edward Maytin, MD, PhD, The Cleveland Clinic

Tracking Information
First Submitted Date  ICMJE April 25, 2014
First Posted Date  ICMJE April 28, 2014
Last Update Posted Date April 12, 2019
Study Start Date  ICMJE April 2014
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 25, 2014)
AK clearance [ Time Frame: at 3 months post-treatment ]
The primary endpoint is treatment efficacy (AK lesion clearance at 3 months). The specific aim of this study is to establish proof-of-principle for the concept that a long delivery period of blue light from the Blu-U device, using the standard fluence rate but starting only 15 min after the application of Levulan and lasting 1 hour (fluence of 360 J/cm2), can provide a clearance rate of AK lesions comparable to a standard regimen of Blu-U light (fluence of 10 J/cm2) beginning 1 hr after LevulanTM application.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02124733 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 25, 2014)
Pain during illumination [ Time Frame: During treatment through post-treatment Day4 ]
The secondary endpoint is pain during illumination. The hypothesis is that efficacy at 3 months will be statistically equivalent with the two approaches, but pain will be significantly less with the continuous treatment regimen.
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 Protocols for Painless Photodynamic Therapy (PDT) of Actinic Keratoses
Official Title  ICMJE Simultaneous Incubation/Illumination Versus Short Aminolevulinate Preincubation for Painless Photodynamic Therapy of Actinic Keratoses
Brief Summary This study is being done to compare a new, continuous illumination regimen of ALA-PDT (Aminolevulinate-Photodynamic Therapy) to a conventional regimen for treatment of actinic keratoses. The hypothesis is that the continuous illumination approach will be less painful, but equally efficacious, as the old regimen.
Detailed Description This study is being done to compare two modified versions of the standard ALA-PDT (Aminolevulinate-Photodynamic Therapy) treatment of actinic keratoses. The treatment has been modified in one of two ways, either: (#1) a shortened incubation time (1 hr), or (#2) light exposure that begins immediately after application of the Levulan. We hypothesize that this will yield a therapeutic efficacy equivalent to the standard ALA-PDT regimen, but will cause less pain during the light exposure. The study employs a bilateral design in which the left versus right sides of the treatment area are compared on the same patient.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description:
Evaluator assesses photographs without prior knowledge of intervention
Primary Purpose: Treatment
Condition  ICMJE Actinic Keratosis
Intervention  ICMJE Procedure: Aminolevulinic acid based photodynamic therapy
The PDT treatments will be done in two stages. ALA (Levulan® Kerastick™) will be applied to the entire treatment area, and then the longer light exposure (lasting up to 1 hr) will be performed on one-half of the treatment area (Side A). After that, a shorter (16 min 40 sec) light exposure will be done on the other half (Side B).
Other Names:
  • Levulan® Kerastick™
  • Blu-U
Study Arms  ICMJE
  • Active Comparator: Group 1: 30 minutes
    The first 4 patients enrolled will be considered Group 1, and will receive 30 min of Aminolevulinic acid based photodynamic therapy to Side A. They will be evaluated in terms of erythema immediately post-PDT (Day 1) and on Day 4 . If there is no clinical reaction on Side A after 2 patients, then the dose will be advanced to the next Group. If the post-PDT reaction (erythema at Day 4) on Side A equals or exceeds the reaction on Side B in the majority of the first 4 patients, then the dose will not be escalated and recruitment will continue until 15 patients have been treated (thereby completing the study). If the post-PDT reaction on Side A is less than the reaction on Side B in the majority of the 4 patients, then the protocol will advance to Group 2
    Intervention: Procedure: Aminolevulinic acid based photodynamic therapy
  • Active Comparator: Group 2: 45 minutes
    Patients in this group will receive 45 min of Aminolevulinic acid based photodynamic therapy to Side A. They will be evaluated for erythema response immediately post-PDT and at Day 4. If there is no clinical reaction on Side A after 2 patients, then the dose will be advanced to the next Group. If the post-PDT reaction (erythema at Day 4) on Side A equals or exceeds the reaction on Side B in the majority of the first 4 patients, then the dose will not be escalated and recruitment will continue until 15 patients have been treated (thereby completing the study). If the post-PDT reaction on Side A is less than the reaction on Side B in the majority of the 4 patients, then the protocol will advance to Group 3.
    Intervention: Procedure: Aminolevulinic acid based photodynamic therapy
  • Active Comparator: Group 3: 60 minutes
    Patients in this group will receive 60 min of Aminolevulinic acid based photodynamic therapy to Side A. They will be evaluated for erythema responses immediately post-PDT and at Day 4. If the post-PDT reaction on Side A equals or exceeds the reaction on Side B in the majority of the first 4 patients, then the dose will not be escalated and recruitment will continue until 15 patients have been treated (thereby completing the study). If the post-PDT reaction on Side A is less than the reaction on Side B in the majority of patients, then the protocol will terminate after 15 patients (total for all groups) have been treated.
    Intervention: Procedure: Aminolevulinic acid based 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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 24, 2018)
36
Original Estimated Enrollment  ICMJE
 (submitted: April 25, 2014)
15
Estimated Study Completion Date  ICMJE December 2019
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Males or females, at least 18 years of age
  • Non-hyperkeratotic actinic keratoses, at least 6 in number (3 on each side of scalp, face or upper extremities)

Exclusion Criteria:

  • patient is currently pregnant or are planning to conceive during the course of the study period
  • patient is using topical therapy or other treatment for these actinic keratoses
  • patient has a known hypersensitivity to 5-aminolevulinic acid
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Lisa Rittwage, BSN, RN 216-444-4659 rittwal@ccf.org
Contact: Edward Maytin, MD, PhD 216-444-5139 maytine@ccf.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02124733
Other Study ID Numbers  ICMJE 14-374
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Edward Maytin, MD, PhD, The Cleveland Clinic
Study Sponsor  ICMJE The Cleveland Clinic
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Edward Maytin, MD, PhD The Cleveland Clinic
PRS Account The Cleveland Clinic
Verification Date February 2019

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