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NCT06027619 · ClinicalTrials.gov registry record · Phase 2
Short Contact Protocols to Reduce Pain During 10% ALA Gel Red-light Photodynamic Therapy of Actinic Keratoses
A Phase 2 study, sponsored by Case Comprehensive Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 30
- Enrollment target
NCT06027619 is a Phase 2 study that has completed, run by Case Comprehensive Cancer Center. The registered enrollment target is 30 participants.
The verdict
NCT06027619, a Phase 2 study, has completed, sponsored by Case Comprehensive Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 30 participants
- Enrollment target
Study 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.
Interventions
- DRUG Topical aminolevulinate (10% ALA gel)
- DEVICE Red light illumination
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2023-10-02 |
| Est. Completion | 2024-07-08 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06027619
The ClinicalTrials.gov registry entry for NCT06027619 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Case Comprehensive Cancer Center, which has 407 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Topical aminolevulinate (10% ALA gel) is the first listed.
NCT06027619 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT06027619 about?
NCT06027619 is a clinical study titled "Short Contact Protocols to Reduce Pain During 10% ALA Gel Red-light Photodynamic Therapy of Actinic Keratoses". 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...
What is the current status of trial NCT06027619?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2023-10-02. Estimated completion is 2024-07-08.
What interventions are being tested in trial NCT06027619?
The interventions under investigation include: Topical aminolevulinate (10% ALA gel) (DRUG), Red light illumination (DEVICE).
Who is sponsoring clinical trial NCT06027619?
This trial is sponsored by Case Comprehensive Cancer Center, which has 407 total clinical trials registered on ClinicalTrials.gov.
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