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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 is a Phase 1 study that has completed, run by Lutris Pharma. The registered enrollment target is 28 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04261387
The ClinicalTrials.gov registry entry for NCT04261387 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 28 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Lutris Pharma, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which LUT014 Gel is the first listed.
NCT04261387 reports 0 study locations.
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.
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