Clinical trial NCT06027619: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Actinic Keratosis
Keywords: Actinic Keratoses
Actinic Keratosis
Photodynamic Therapy
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: The Cleveland Clinic
name: Biofrontera, Inc.
First posted: 2023-09-07
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Treatment Efficacy based on Participant AK Lesion Clearance
timeFrame: Lesion clearance at Visit 3 (month 2) and at Visit 4 (month 6)
measure: Differences in Pain Level Reported Throughout Exposure to Red Light
timeFrame: Pain measured during illumination with red light (during a 10 min period) at Visit 1 and at Visit 3
Secondary outcomes:
measure: Differences in Scores Reported on Patient Satisfaction Survey
timeFrame: At month 6
measure: Number of Participant Reported Adverse Events and side effects
timeFrame: At day 2-4 post-treatment
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic, Dermatology and Plastic Surgery Institute, Case Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Cleveland Clinic, Dermatology and Plastic Surgery Institute, Case Comprehensive Cancer Center
name: Edward V Maytin, M.D. Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: