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LUT014 Gel for Radiation Skin Damage

Phase 1 & 2
Waitlist Available
Research Sponsored by Lutris Pharma Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Completed fractionated radiation therapy for breast prior to first dose of study drug (Day 0);
A score of ≥ 6 reported in the Dermatology Life Quality Index at the Screening and Baseline Visits;
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks (83 days)
Awards & highlights

Study Summary

This trial will test a new gel to see if it can help heal radiation dermatitis, a side effect of cancer treatment. The gel will be applied once a day for 28 days, and patients will be monitored for two months after treatment.

Eligible Conditions
  • Radiation Skin Damage

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks (83 days)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks (83 days) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in the severity of radiation dermatitis based on self reporting Dermatology QoL questionnaire (Part 2 subjects)
Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE (Part 1 subjects)
Secondary outcome measures
Change in the severity of radiation dermatitis assessed by CTCAE (Part 1 subjects)
Change in the severity of radiation dermatitis assessed by RTOG/EORTC (part 1 subjects)
Change in the severity of radiation dermatitis based on self reporting Dermatology QoL questionnaire
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: LUT014 GelExperimental Treatment1 Intervention
LUT014 Gel topical application to the dermatitis area qd for 28 days
Group II: Placebo for LUT014 GelPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
LUT014 Gel
2021
Completed Phase 2
~30

Find a Location

Who is running the clinical trial?

Lutris Pharma Ltd.Lead Sponsor
2 Previous Clinical Trials
127 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
LUT014 for the Treatment of Radiation Induced Dermatitis in Breast Cancer Patients
2021. "LUT014 for the Treatment of Radiation Induced Dermatitis in Breast Cancer Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04261387.
~7 spots leftby Apr 2025
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