NCT04261387

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

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Lutris Pharma Ltd. · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Radiation Dermatitis

Interventions

Type	Name	Description
DRUG	LUT014 Gel	Topical application qd for 28 days
DRUG	Placebo for LUT014 Gel	Matching placebo for qd topical application for 28 days

Timeline

• Start date: 2021-01-30
• Primary completion: 2022-06-16
• Completion: 2022-07-15
• First posted: 2020-02-07
• Last updated: 2022-07-27

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study