Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 2 study, sponsored by Case Comprehensive Cancer Center.
NCT06027619 is a Phase 2 study that has completed, run by Case Comprehensive Cancer Center. The registered enrollment target is 30 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
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.
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 |
What the finished NCT06027619 record still lists
NCT06027619 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 2 interventions - of which Topical aminolevulinate (10% ALA gel) is the first listed.
NCT06027619 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06027619's enrollment target sits among peer trials
30 1582nd of 2000 higher than 332 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00977977 · 30 participants · Phase 2
Rituximab Plus Cyclosporine in Idiopathic Membranous Nephropathy
- NCT01459107 · 30 participants · Phase 2
Human Upper Extremity Allotransplantation
- NCT01666080 · 30 participants · NA
Second or Greater Allogeneic Hematopoietic Stem Cell Transplant Using Reduced Intensity Conditioning (RIC)
- NCT01720836 · 30 participants · Phase 1
Study of the Immune Response of MUC1 (Mucin1) Peptide Vaccine for Non-small Cell Lung Cancer
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI