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

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.

Timeline

Start

2021-01-30

Primary completion

2022-06-16

Completion

2022-07-15

Drugs

Indications