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NCT02124733 · ClinicalTrials.gov registry record · Phase 3
Protocols for Painless Photodynamic Therapy (PDT) of Actinic Keratoses
A Phase 3 study, sponsored by The Cleveland Clinic.
- Completed
- Registry status
- Phase 3
- Development phase
- 23
- Enrollment target
NCT02124733: Completed Phase 3 study, sponsored by The Cleveland Clinic.
NCT02124733 is a Phase 3 study that has completed, run by The Cleveland Clinic. The registered enrollment target is 23 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02124733, a Phase 3 study, has completed, sponsored by The Cleveland Clinic.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 23 participants
- Enrollment target
Study Summary
This study is being done to compare a new, continuous illumination regimen of ALA-PDT (Aminolevulinate-Photodynamic Therapy) to a conventional regimen for treatment of actinic keratoses. The hypothesis is that the continuous illumination approach will be less painful, but equally efficacious, as the old regimen.
Primary Outcome
The primary endpoint is treatment efficacy (AK lesion clearance at 3 months). The specific aim of this study is to establish proof-of-principle for the concept that a long delivery period of blue light from the Blu-U device, using the standard fluence rate but starting only 15 min after the application of Levulan and lasting 1 hour (fluence of 360 J/cm2), can provide a clearance rate of AK lesions comparable to a standard regimen of Blu-U light (fluence of 10 J/cm2) beginning 1 hr after LevulanT
Interventions
- PROCEDURE Aminolevulinic acid based photodynamic therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2014-04 |
| Est. Completion | 2018-12 |
| Phase | Phase 3 |
What the finished NCT02124733 record still lists
NCT02124733 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 1 intervention - of which Aminolevulinic acid based photodynamic therapy is the first listed.
NCT02124733 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02124733 about?
NCT02124733 is a clinical study titled "Protocols for Painless Photodynamic Therapy (PDT) of Actinic Keratoses". This study is being done to compare a new, continuous illumination regimen of ALA-PDT (Aminolevulinate-Photodynamic Therapy) to a conventional regimen for treatment of actinic keratoses. The hypothesis is that the continuous illumination approach will be less painful, but equally efficacious, as the...
What is the current status of trial NCT02124733?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 23 participants. The study started on 2014-04. Estimated completion is 2018-12.
What interventions are being tested in trial NCT02124733?
The interventions under investigation include: Aminolevulinic acid based photodynamic therapy (PROCEDURE).
Who is sponsoring clinical trial NCT02124733?
This trial is sponsored by The Cleveland Clinic, which has 688 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02124733's enrollment target sits among peer trials
23 1952nd of 2000 higher than 48 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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
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