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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 belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks (83 days)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks (83 days)
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 moreTrial 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
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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.
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