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NCT04261387 · ClinicalTrials.gov registry record · Phase 1
LUT014 for the Treatment of Radiation Induced Dermatitis in Breast Cancer Patients
A Phase 1 study, sponsored by Lutris Pharma.
- Completed
- Registry status
- Phase 1
- Development phase
- 28
- Enrollment target
NCT04261387: Completed Phase 1 study, sponsored by Lutris Pharma.
NCT04261387 is a Phase 1 study that has completed, run by Lutris Pharma. 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
NCT04261387, a Phase 1 study, has completed, sponsored by Lutris Pharma.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 28 participants
- Enrollment target
Study Summary
The study will evaluate the safety, tolerability and efficacy of LUT014 gel topically administered in breast cancer patients who developed radiation dermatitis. Subjects enrolled to part 1 will be enrolled to receive the study treatment (open label treatment) for 28 days and will be followed up for 2 months after the completion of study treatment. Subject in Part 2 will be randomized in 1:1 ratio to receive either the study drug or placebo (double-blind treatment) for qd topical application for 28 days and will be followed up for 2 months after the completion of study treatment.
Primary Outcome
Common Terminology Criteria for Adverse Events Version 5.0
Interventions
- DRUG LUT014 Gel
- DRUG Placebo for LUT014 Gel
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2021-01-30 |
| Est. Completion | 2022-07-15 |
| Phase | Phase 1 |
What the finished NCT04261387 record still lists
NCT04261387 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 2 interventions - of which LUT014 Gel is the first listed.
NCT04261387 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04261387 about?
NCT04261387 is a clinical study titled "LUT014 for the Treatment of Radiation Induced Dermatitis in Breast Cancer Patients". The study will evaluate the safety, tolerability and efficacy of LUT014 gel topically administered in breast cancer patients who developed radiation dermatitis. Subjects enrolled to part 1 will be enrolled to receive the study treatment (open label treatment) for 28 days and will be followed up for ...
What is the current status of trial NCT04261387?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 28 participants. The study started on 2021-01-30. Estimated completion is 2022-07-15.
What interventions are being tested in trial NCT04261387?
The interventions under investigation include: LUT014 Gel (DRUG), Placebo for LUT014 Gel (DRUG).
Who is sponsoring clinical trial NCT04261387?
This trial is sponsored by Lutris Pharma, which has 2 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04261387'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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