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Retinoid
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
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
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Topical Tretinoin
2022
Completed Phase 2
~20
Find a Location
Who is running the clinical trial?
University of UtahLead Sponsor
1,147 Previous Clinical Trials
1,699,596 Total Patients Enrolled
Christopher Nevala-Plagemann, MDPrincipal InvestigatorHuntsman Cancer Institute
1 Previous Clinical Trials
96 Total Patients Enrolled