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NCT03643744 · ClinicalTrials.gov registry record · Phase 1
Photodynamic Therapy-Induced Immune Modulation: Part III
A Phase 1 study, sponsored by Wright State University.
- Terminated
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
NCT03643744: Clinical Trial Phase 1 study, sponsored by Wright State University.
NCT03643744 is a Phase 1 study that was terminated before completion, run by Wright State University. The registered enrollment target is 12 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03643744, a Phase 1 study, was terminated before completion, sponsored by Wright State University.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
Study Summary
This study is designed as a double-blinded proof of concept of feasibility study to define if the immunosuppression associated with photodynamic therapy (PDT) can be blocked by treatment with cyclo-oxygenase-2 (COX-2) inhibitor celecoxib in comparison to placebo. PDT consists of application of the photosensitizer 5-aminolevulinic acid followed by treatment with a blue light. PDT is used to treat pre-cancerous actinic keratosis on large areas of skin. These studies are a continuation of ongoing studies that indicate that the lipid mediator platelet-activating factor (PAF) is generated in skin following PDT, and that PDT suppresses the immune system. It is hypothesized that PDT-generated PAF results in the immunosuppression associated with PDT. Therefore, it is proposed that a treatment to block that immunosuppression could protect the patient undergoing PDT. Blockers of the PAF system are not currently commercially available. However research studies done at Wright State University using mice indicate that PAF- and PDT-induced immunosuppression is blocked by treatment with COX-2 inhibitors. This study is conducted as a proof of concept. Study length and visit for subjects with actinic keratoses: The first part of the study is completed in 12 days then there are follow up visits at 6 and 12 months. There are a total of 6 separate visits to the research office. Study length and visit for control subjects: The study is completed in 10 days. There are a total of 4 separate visits to the research office.
Primary Outcome
Investigator measures areas of inflammation from the reactions to intradermal (candida and trichophyton antigens) skin testing to calculate the areas of reaction. The areas of induration were measured using calipers with cm2 as the unit of measurement. The outcome measurement was calculated by using the cm2 measurements from baseline and Day 7 to calculate the percentage of initial reaction area.
Interventions
- DRUG Placebo
- DRUG Celecoxib 200mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2019-04-01 |
| Est. Completion | 2023-03-21 |
| Phase | Phase 1 |
Why NCT03643744 stopped before completion
NCT03643744 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03643744 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03643744 about?
NCT03643744 is a clinical study titled "Photodynamic Therapy-Induced Immune Modulation: Part III". This study is designed as a double-blinded proof of concept of feasibility study to define if the immunosuppression associated with photodynamic therapy (PDT) can be blocked by treatment with cyclo-oxygenase-2 (COX-2) inhibitor celecoxib in comparison to placebo. PDT consists of application of the p...
What is the current status of trial NCT03643744?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2019-04-01. Estimated completion is 2023-03-21.
What interventions are being tested in trial NCT03643744?
The interventions under investigation include: Placebo (DRUG), Celecoxib 200mg (DRUG).
Who is sponsoring clinical trial NCT03643744?
This trial is sponsored by Wright State University, which has 32 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03643744's enrollment target sits among peer trials
12 1852nd of 2000 higher than 90 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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