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Short Contact Protocols to Reduce Pain During 10% ALA Gel Red-light Photodynamic Therapy of Actinic Keratoses

Primary Purpose

Actinic Keratosis

Status
Not yet recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Topical aminolevulinate (10% ALA gel)
Red light illumination
Sponsored by
Case Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Actinic Keratosis focused on measuring Actinic Keratoses, Actinic Keratosis, Photodynamic Therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Minimum of 10 actinic keratoses lesions on the face. Female subjects must not become pregnant during the study Subjects must be able to understand and willing to sign a written informed consent document. Exclusion Criteria: Pregnant or nursing. Using any topical treatment on their AKs; must stop at least one month prior. Currently undergoing treatment 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 history of a photosensitivity disease, such as porphyria cutanea tarda.

Sites / Locations

  • Cleveland Clinic, Dermatology and Plastic Surgery Institute, Case Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Regimen A

Regimen B

Regimen C

Arm Description

Apply topical aminolevulinic acid gel and incubate for 10 minutes prior to red light source

Apply topical aminolevulinic acid gel and incubate for 20 minutes prior to red light source

Apply topical aminolevulinic acid gel and incubate for 60 minutes prior to red light source

Outcomes

Primary Outcome Measures

Treatment Efficacy based on Participant AK Lesion Clearance
To test the hypothesis that a short-contact PDT protocol with Ameluz and red light will produce lesion clearance outcomes that are statistically non-inferior to the traditional, painful protocol. This will be measured by Clinical Efficacy, which will be based on the AK lesion counts and lesion clearance rate after two treatments.
Differences in Pain Level Reported Throughout Exposure to Red Light
To demonstrate that a short-contact PDT protocol with Ameluz and red light generates less pain during illumination than the standard FDA-approved protocol currently used. Pain will be reported by the participants during illumination will be measured on a subjective 11-point visual-analog scale (VAS) at 1 min, 5 min, and 10 min.

Secondary Outcome Measures

Differences in Scores Reported on Patient Satisfaction Survey
To test the hypothesis that a short-contact PDT protocol with Ameluz and red light will be better tolerated and provide higher patient satisfaction than the currently practiced protocol. Participant satisfaction will be measured by completing a Subject Satisfaction Questionnaire survey.
Number of Participant Reported Adverse Events and side effects
Overall AE Profile and Safety of treatment will be measured using an Adverse Events- Patients' side effects log and Investigator assessment.

Full Information

First Posted
August 31, 2023
Last Updated
October 24, 2023
Sponsor
Case Comprehensive Cancer Center
Collaborators
The Cleveland Clinic, Biofrontera, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT06027619
Brief Title
Short Contact Protocols to Reduce Pain During 10% ALA Gel Red-light Photodynamic Therapy of Actinic Keratoses
Official Title
Short Contact Protocols to Reduce Pain During Treatment of Actinic Keratoses With 10% ALA Gel Red-light Photodynamic Therapy (PDT)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 1, 2024 (Anticipated)
Primary Completion Date
June 1, 2024 (Anticipated)
Study Completion Date
December 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Case Comprehensive Cancer Center
Collaborators
The Cleveland Clinic, Biofrontera, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The goal of this clinical trial is to see if shorter Photodynamic Therapy (PDT) treatment times will still be effective at treating actinic keratoses (AK) while reducing or eliminating the pain that patients sometimes experience during conventional PDT treatment. The main questions it aims to answer are: Will the application of the nanoemulsion (10% ALA gel), in the absence of occlusion, still achieve significant inflammation and lesion clearance? Will shortened incubation times of Ameluz still achieve significant inflammation and lesion clearance? Will the new test regimens achieve reduced pain during illumination? Will the new test regimens be safe? Participants will be randomly assigned to one of three treatment regimens, which will determine the length of time that the topical medication will incubate on the face before red light exposure in PDT treatments. The incubation period will be either 10 minutes, 20 minutes, or 60 minutes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Actinic Keratosis
Keywords
Actinic Keratoses, Actinic Keratosis, Photodynamic Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Regimen A
Arm Type
Experimental
Arm Description
Apply topical aminolevulinic acid gel and incubate for 10 minutes prior to red light source
Arm Title
Regimen B
Arm Type
Experimental
Arm Description
Apply topical aminolevulinic acid gel and incubate for 20 minutes prior to red light source
Arm Title
Regimen C
Arm Type
Experimental
Arm Description
Apply topical aminolevulinic acid gel and incubate for 60 minutes prior to red light source
Intervention Type
Drug
Intervention Name(s)
Topical aminolevulinate (10% ALA gel)
Other Intervention Name(s)
Ameluz gel, 10% aminolevulinic acid
Intervention Description
10% ALA gel to the entire face, without occlusion, followed by a prespecified incubation period
Intervention Type
Device
Intervention Name(s)
Red light illumination
Other Intervention Name(s)
BF-RhodoLED® Light Source
Intervention Description
Illumination of red light of narrow spectrum of 635 nm with a light dose of approximately 37 J/cm2
Primary Outcome Measure Information:
Title
Treatment Efficacy based on Participant AK Lesion Clearance
Description
To test the hypothesis that a short-contact PDT protocol with Ameluz and red light will produce lesion clearance outcomes that are statistically non-inferior to the traditional, painful protocol. This will be measured by Clinical Efficacy, which will be based on the AK lesion counts and lesion clearance rate after two treatments.
Time Frame
Lesion clearance at Visit 3 (month 2) and at Visit 4 (month 6)
Title
Differences in Pain Level Reported Throughout Exposure to Red Light
Description
To demonstrate that a short-contact PDT protocol with Ameluz and red light generates less pain during illumination than the standard FDA-approved protocol currently used. Pain will be reported by the participants during illumination will be measured on a subjective 11-point visual-analog scale (VAS) at 1 min, 5 min, and 10 min.
Time Frame
Pain measured during illumination with red light (during a 10 min period) at Visit 1 and at Visit 3
Secondary Outcome Measure Information:
Title
Differences in Scores Reported on Patient Satisfaction Survey
Description
To test the hypothesis that a short-contact PDT protocol with Ameluz and red light will be better tolerated and provide higher patient satisfaction than the currently practiced protocol. Participant satisfaction will be measured by completing a Subject Satisfaction Questionnaire survey.
Time Frame
At month 6
Title
Number of Participant Reported Adverse Events and side effects
Description
Overall AE Profile and Safety of treatment will be measured using an Adverse Events- Patients' side effects log and Investigator assessment.
Time Frame
At day 2-4 post-treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Minimum of 10 actinic keratoses lesions on the face. Female subjects must not become pregnant during the study Subjects must be able to understand and willing to sign a written informed consent document. Exclusion Criteria: Pregnant or nursing. Using any topical treatment on their AKs; must stop at least one month prior. Currently undergoing treatment 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 history of a photosensitivity disease, such as porphyria cutanea tarda.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Edward V Maytin, M.D. Ph.D.
Phone
(216) 445-6676
Email
maytine@ccf.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edward V Maytin, M.D. Ph.D.
Organizational Affiliation
Cleveland Clinic, Dermatology and Plastic Surgery Institute, Case Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland Clinic, Dermatology and Plastic Surgery Institute, Case Comprehensive Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Time Frame
Data will be available 12/2024

Learn more about this trial

Short Contact Protocols to Reduce Pain During 10% ALA Gel Red-light Photodynamic Therapy of Actinic Keratoses

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