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LUT014 for the Treatment of Radiation Induced Dermatitis in Breast Cancer Patients

Radiation Dermatitis Clinical Trial

Official title:
A Two-Part (Open-Label Followed by Randomized, Double-Blind, Placebo-Controlled) Phase 1/2 Study to Evaluate the Safety, Tolerability, and Efficacy of Topically Administered LUT014 for the Treatment of Radiation-Induced Dermatitis in Breast Cancer Patients

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04261387
Study type Interventional
Source Lutris Pharma Ltd.
Contact
Status Completed
Phase Phase 1/Phase 2
Start date January 30, 2021
Completion date July 15, 2022
View Details
See also
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