Topical Tretinoin for Colon Cancer (FACE Trial)

Phase 2

Recruiting

Led By Christopher Nevala-Plagemann, MD

Research Sponsored by University of Utah

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 weeks

Summary

This trial aims to see if applying a cream called tretinoin can help patients with colorectal cancer who have a rash from their treatment. The researchers will compare tretinoin to a fake

Who is the study for?

Adults over 18 with metastatic colorectal cancer, who are about to start or are currently receiving panitumumab or cetuximab treatment. They must have good organ function and performance status, not be pregnant, agree to use contraception if applicable, and have recovered from previous cancer treatments.

What is being tested?

The trial is testing whether topical tretinoin can prevent or reduce skin rash side effects in patients treated with anti-EGFR drugs for colorectal cancer. One side of the face will receive tretinoin while the other side gets a placebo to compare results.

What are the potential side effects?

Potential side effects of topical tretinoin may include skin irritation, redness, peeling at the application site, increased sensitivity to sunlight, dry skin, itching and temporary worsening of acne symptoms.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

The maximum difference in modified Investigators Global Assessment (IGA) score between the treated and untreated sides of the face at any assessment.

Secondary study objectives

Frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by type, severity (as defined by the NIH CTCAE version 5.0 and the modified IGA), seriousness, duration, and relationship to study treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Tretinoin half of face (right) and Placebo/Moisturizer other half of the face (left)Experimental Treatment1 Intervention

Randomized, double-blind, split-face. Randomization will determine which side of the face Tretinoin will be applied to (left or right). The other side of the face (left or right) will have placebo applied. All participants will receive both treatment and placebo.

Group II: Tretinoin half of face (left) and Placebo/Moisturizer other half of the face (right)Experimental Treatment1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Topical Tretinoin

2022

Completed Phase 2

~20

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