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NCT04475432 · ClinicalTrials.gov registry record · Phase 2
Safety and Efficacy of TP-03 for the Treatment of Demodex Blepharitis
A Phase 2 study, sponsored by Tarsus Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 421
- Enrollment target
NCT04475432: Completed Phase 2 study, sponsored by Tarsus Pharmaceuticals.
NCT04475432 is a Phase 2 study that has completed, run by Tarsus Pharmaceuticals. The registered enrollment target is 421 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (217% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04475432, a Phase 2 study, has completed, sponsored by Tarsus Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 421 participants
- Enrollment target
Study Summary
The purpose of this study is to compare the safety and efficacy of TP-03, 0.25%, an eyedrop, to its vehicle control for the treatment of blepharitis due to Demodex, a microscopic mite frequently found in human hair follicles. The hypothesis for the study is the proportion of participants cured at Day 43 with treatment by TP-03, 0.25%, is greater than the proportion cured by treatment with its vehicle.
Primary Outcome
The proportion of participants cured where cure is defined as 0-2 lashes with collarettes on the upper eyelid of the analysis eye. The primary outcome analysis is the combined result from 20 analyses each with missing data imputed. Missing data were imputed per the method described in the SAP. The least square mean is computed from the result of the 20 analyses with imputed missing values.
Interventions
- DRUG TP-03 Vehicle
- DRUG TP-03, 0.25%
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 421 participants |
| Start Date | 2020-09-09 |
| Est. Completion | 2021-05-04 |
| Phase | Phase 2 |
What the finished NCT04475432 record still lists
NCT04475432 is an interventional study that assigns participants to a tested intervention. The registered 421 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (217% higher).
The record links to 0 conditions, and to 2 interventions - of which TP-03 Vehicle is the first listed.
NCT04475432 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04475432 about?
NCT04475432 is a clinical study titled "Safety and Efficacy of TP-03 for the Treatment of Demodex Blepharitis". The purpose of this study is to compare the safety and efficacy of TP-03, 0.25%, an eyedrop, to its vehicle control for the treatment of blepharitis due to Demodex, a microscopic mite frequently found in human hair follicles. The hypothesis for the study is the proportion of participants cured at Da...
What is the current status of trial NCT04475432?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 421 participants. The study started on 2020-09-09. Estimated completion is 2021-05-04.
What interventions are being tested in trial NCT04475432?
The interventions under investigation include: TP-03 Vehicle (DRUG), TP-03, 0.25% (DRUG).
Who is sponsoring clinical trial NCT04475432?
This trial is sponsored by Tarsus Pharmaceuticals, which has 9 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04475432's enrollment target sits among peer trials
421 91st of 2000 higher than 1,910 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
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