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Topical Gel for Acne-like Skin Issues from Cancer Treatment

Phase 2

Recruiting

Research Sponsored by Lutris Pharma Ltd.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Currently being treated with an FDA approved monoclonal antibody EGFRI for the treatment of mCRC, including but not limited to Erbitux® (cetuximab) Injection and Vectibix® (panitumumab) Injection, as directed by the approved labeling

Diagnosed with mCRC

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 8-16 weeks (56-84 days)

Awards & highlights

Study Summary

This trial looks at whether a topical gel can help improve acne-like lesions caused by taking certain drugs for colorectal cancer.

Who is the study for?

This trial is for adults with metastatic colorectal cancer (mCRC) who are currently being treated with certain FDA-approved EGFRI drugs and have developed Grade 2 or non-infected Grade 3 acneiform lesions. Participants should be able to apply the gel themselves or have someone to help, not have other cancers within the last three years, and women must test negative for pregnancy.Check my eligibility

What is being tested?

The study tests two different doses of LUT014 Gel against a placebo in mCRC patients with specific skin lesions from EGFRI treatment. The gels are applied daily for four weeks to see if they reduce these skin issues better than a placebo.See study design

What are the potential side effects?

While the trial information provided does not specify side effects, typical side effects of topical treatments may include skin irritation, redness, itching, dryness at the application site. Patients will be monitored for any adverse reactions.

Eligibility Criteria

Inclusion Criteria

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

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I am currently receiving an FDA-approved monoclonal antibody treatment for my colorectal cancer.

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I have been diagnosed with metastatic colorectal cancer.

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I can take care of myself and am up and about more than half of my waking hours.

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I have moderate to severe acne that is not infected.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 8-16 weeks (56-84 days)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~8-16 weeks (56-84 days)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 8-16 weeks (56-84 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

The proportion of subjects in each treatment group who reached treatment success

Secondary outcome measures

Change in the FACT-EGFRI-18 questionnaire total score for the skin-specific questions from baseline to Days 7, 14, 21, 28, and 55. For subjects enrolled in the OLE, the change from pre-dose Day 28 to Days 35, 42, 49, 56, and 84 will also be evaluated;

Change in the severity of acneiform lesions based on CTCAE grading scale from baseline to Days 7, 14, 21, 28, and 55. For subjects enrolled in the OLE, the change from pre-dose Day 28 to Days 35, 42, 49, 56, and 84 will also be evaluated;

Number of AEs and the number and percentage of subjects with AEs

+2 more

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: LUT014 Gel (Dose 2)Experimental Treatment1 Intervention

Group II: LUT014 Gel (Dose 1)Experimental Treatment1 Intervention

Group III: PlaceboPlacebo Group1 Intervention

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Lutris Pharma Ltd.Lead Sponsor

2 Previous Clinical Trials

38 Total Patients Enrolled

Media Library

LUT014 Gel (Dose 2) Clinical Trial Eligibility Overview. Trial Name: NCT04759664 — Phase 2

Acneiform Lesions Research Study Groups: LUT014 Gel (Dose 1), LUT014 Gel (Dose 2), Placebo

Acneiform Lesions Clinical Trial 2023: LUT014 Gel (Dose 2) Highlights & Side Effects. Trial Name: NCT04759664 — Phase 2

LUT014 Gel (Dose 2) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04759664 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What has been observed regarding the potential risks of utilizing LUT014 Gel (Dose 2)?

"While Phase 2 clinical data is still being collected, our assessment at Power has assigned LUT014 Gel (Dose 2) a score of two on the safety scale. This implies some form of assurance but no evidence yet for its efficacy."

Answered by AI

Is this clinical study currently open for enrollment?

"According to the clinicaltrials.gov listing, this trial is currently recruiting participants after being posted on April 12th 2021 and last updated September 6th 2022."

Answered by AI

At how many sites is this research endeavor being conducted?

"The medical trial is administered by Appalachian Regional Healthcare in Hazard, Kentucky, MultiCare Institute for Research and Innovation in Tacoma, Washington, Revive Research Institute in Farmington Hills, Michigan as well as 13 additional healthcare centres."

Answered by AI

What is the current enrollment for this clinical investigation?

"This medical research necessitates the involvement of 117 eligible participants. Those that feel they meet the criteria can join from Appalachian Regional Healthcare in Hazard, Kentucky or MultiCare Institute for Research and Innovation in Tacoma, Washington."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

LUT014 for the Reduction of Dose-Limiting Acneiform Lesions Associated With EGFRI Treatment of mCRC

2021. "LUT014 for the Reduction of Dose-Limiting Acneiform Lesions Associated With EGFRI Treatment of mCRC". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04759664.

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