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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

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.

Condition or disease Intervention/treatment Phase
Actinic Keratosis Procedure: Aminolevulinic acid based photodynamic therapy Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: Evaluator assesses photographs without prior knowledge of intervention
Primary Purpose: Treatment
Official Title: Simultaneous Incubation/Illumination Versus Short Aminolevulinate Preincubation for Painless Photodynamic Therapy of Actinic Keratoses
Study Start Date : April 2014
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
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

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.
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

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.
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT02124733


Contacts
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Contact: Lisa Rittwage, BSN, RN 216-444-4659 rittwal@ccf.org
Contact: Edward Maytin, MD, PhD 216-444-5139 maytine@ccf.org

Locations
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United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Lisa Rittwage, BSN, RN    216-444-4659    rittwal@ccf.org   
Contact: Edward Maytin, PhD MD    216-444-5139    maytine@ccf.org   
Sub-Investigator: Allison Vidimos, MD         
Sub-Investigator: Christine Warren, MD         
Sponsors and Collaborators
The Cleveland Clinic
Investigators
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Principal Investigator: Edward Maytin, MD, PhD The Cleveland Clinic

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Responsible Party: Edward Maytin, MD, PhD, MD, PhD, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT02124733     History of Changes
Other Study ID Numbers: 14-374
First Posted: April 28, 2014    Key Record Dates
Last Update Posted: April 12, 2019
Last Verified: February 2019
Keywords provided by Edward Maytin, MD, PhD, The Cleveland Clinic:
Actinic Keratosis
Actinic Keratoses
AK
PDT
Photodynamic Therapy
Blue Light Therapy
ALA
aminolevulinic acid
Levulan
Additional relevant MeSH terms:
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Keratosis, Actinic
Keratosis
Skin Diseases
Precancerous Conditions
Neoplasms
Aminolevulinic Acid
Photosensitizing Agents
Dermatologic Agents