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

NCT04261387 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2022-07-27

No results posted yet for this 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.

Conditions

  • Radiation Dermatitis

Interventions

DRUG

LUT014 Gel

Topical application qd for 28 days

DRUG

Placebo for LUT014 Gel

Matching placebo for qd topical application for 28 days

Sponsors & Collaborators

  • Lutris Pharma Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-30
Primary Completion
2022-06-16
Completion
2022-07-15
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04261387 on ClinicalTrials.gov