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NCT05797818 · ClinicalTrials.gov registry record · Phase 1
Red Light Photobiomodulation and Topical Disinfectants
A Phase 1 study, sponsored by Ondine Biomedical.
- Completed
- Registry status
- Phase 1
- Development phase
- 28
- Enrollment target
NCT05797818: Completed Phase 1 study, sponsored by Ondine Biomedical.
NCT05797818 is a Phase 1 study that has completed, run by Ondine Biomedical. The registered enrollment target is 28 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (53% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05797818, a Phase 1 study, has completed, sponsored by Ondine Biomedical.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 28 participants
- Enrollment target
Study Summary
The goal of this clinical trial is to evaluate the potential effects of photobiomodulation when used with topical disinfectants in the anterior nares of healthy adults. Over a three week period, participants will have their anterior nares swabbed with methylene blue, chlorhexidine gluconate, or a combination of the two followed by 4 minutes of non-thermal red light treatment. The fourth week of consist of only red light treatment. Culture samples of the subjects nasal microbiome will be taken prior to treatment, immediately after treatment, 4-, 8-, 24-, and 48 hours after treatment.
Primary Outcome
The Quantitative outcome measure is the change from baseline in nasal bacterial bioburden (measured in CFU/mL) by the effects of red light photobiomodulation on nasal bacteria when used with and without topical disinfectants. Each subject's baseline nasal bacterial level is determined prior to the weekly intervention. There are no subject reported outcome measures.
Interventions
- DEVICE Methylene Blue Only
- DEVICE Chlorhexidine Gluconate Only
- DEVICE Methylene Blue + Chlorhexidine Gluconate
- DEVICE Light Only
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2023-01-10 |
| Est. Completion | 2023-02-08 |
| Phase | Phase 1 |
What the finished NCT05797818 record still lists
NCT05797818 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (53% lower).
The record links to 0 conditions, and to 4 interventions - of which Methylene Blue Only is the first listed.
NCT05797818 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05797818 about?
NCT05797818 is a clinical study titled "Red Light Photobiomodulation and Topical Disinfectants". The goal of this clinical trial is to evaluate the potential effects of photobiomodulation when used with topical disinfectants in the anterior nares of healthy adults. Over a three week period, participants will have their anterior nares swabbed with methylene blue, chlorhexidine gluconate, or a c...
What is the current status of trial NCT05797818?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 28 participants. The study started on 2023-01-10. Estimated completion is 2023-02-08.
What interventions are being tested in trial NCT05797818?
The interventions under investigation include: Methylene Blue Only (DEVICE), Chlorhexidine Gluconate Only (DEVICE), Methylene Blue + Chlorhexidine Gluconate (DEVICE), Light Only (DEVICE).
Who is sponsoring clinical trial NCT05797818?
This trial is sponsored by Ondine Biomedical, which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05797818's enrollment target sits among peer trials
28 1447th of 2000 higher than 538 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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