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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06027619
Other study ID # CASE4623
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date October 2, 2023
Est. completion date December 1, 2024

Study information

Verified date December 2023
Source Case Comprehensive Cancer Center
Contact Edward V Maytin, M.D. Ph.D.
Phone (216) 445-6676
Email maytine@ccf.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date December 1, 2024
Est. primary completion date June 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Topical aminolevulinate (10% ALA gel)
10% ALA gel to the entire face, without occlusion, followed by a prespecified incubation period
Device:
Red light illumination
Illumination of red light of narrow spectrum of 635 nm with a light dose of approximately 37 J/cm2

Locations

Country Name City State
United States Cleveland Clinic, Dermatology and Plastic Surgery Institute, Case Comprehensive Cancer Center Cleveland Ohio

Sponsors (3)

Lead Sponsor Collaborator
Case Comprehensive Cancer Center Biofrontera, Inc., The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Lesion clearance at Visit 3 (month 2) and at Visit 4 (month 6)
Primary 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. Pain measured during illumination with red light (during a 10 min period) at Visit 1 and at Visit 3
Secondary 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. At month 6
Secondary 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. At day 2-4 post-treatment
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