NCT06358677

Topical Tretinoin Prophylaxis for Anti-EGFR Induced Skin Toxicity in Patients With Solid Tumors

A Phase II, Randomized, Double-Blind, Split-Face of Topical Tretinoin Prophylaxis for Anti-EGFR Induced Skin Toxicity in Patients With Solid Tumors

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: University of Utah · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to learn if using topical tretinoin will help patients with solid tumors who are experiencing an acneiform rash as a side effect of their treatment. Researchers will compare the use of tretinoin on one side of the face to the use of a placebo on the other side of the face to see if there is an impact.

Detailed description

The anti-epidermal growth factor receptor (anti-EGFR) agents cetuximab and panitumumab have been shown in numerous trials to be active in patients with metastatic colorectal cancer (mCRC). Current American Society of Clinical Oncology guidelines strongly recommend offering an antiEGFR therapy in combination with chemotherapy to patients with treatment-naïve, left-sided, RAS wild-type mCRC. In addition to colorectal cancer, anti-EGFR agents are also approved for use in the management of head and neck, cutaneous squamous cell, and penile cancers. Novel prophylactic approaches are needed so that more patients can benefit from the survival advantage provided by these drugs without a sacrificing quality of life. Tretinoin is a vitamin A derivative (all-trans retinoic acid) that has been used by dermatology for more than five decades and is currently approved for the management of moderate to severe acne vulgaris. Initially, tretinoin was recognized as a potential treatment for acne vulgaris based on its comedolytic properties. However, over the past decade tretinoin has been increasingly recognized for its immunomodulatory properties raising the potential for use in dermatologic disorders other than acne vulgaris. Although the pathogenesis of anti-EGFR associated skin toxicity is still not entirely understood, the clinical presentation shares many similarities with acne vulgaris, and inflammation is felt to play a major role. For this reason, there is interest in the use of tretinoin in the management of anti-EGFR associated rash. Topical tretinoin is associated with minimal transdermal absorption thus making it a viable option for investigation into its use as a prophylactic agent for anti-EGFR associated rash. This split-face study will utilize a topical moisturizer as a placebo applied to the opposite half of the face as the topical tretinoin. Eucerin, a topical emollient will be used as the placebo in this study. Eucerin is not associated with any significant adverse reactions. This is a randomized, double-blind, split-face, phase II study of topical tretinoin prophylaxis for anti-EGFR treatment-induced skin toxicity in patients with locally advanced or metastatic solid tumors. Patients will apply topical tretinoin to one half of the face and topical moisturizer (placebo) to the other half of the face daily, starting the day that anti-EGFR treatment is initiated. The sides of the face tretinoin and moisturizer are applied to will be randomized. Standardized photographs of the face will be obtained at screening and every two weeks from Week 1 Day 1 until after six weeks of treatment. Photographs will be graded by a dermatologist who will be blinded to treatment sidedness. Facial rash severity will be graded using a modified Investigators Global Assessment (IGA) score.

Conditions

• Metastatic Solid Tumor
• Locally Advanced Solid Tumor

Interventions

Type	Name	Description
DRUG	Topical Tretinoin	Topical tretinoin will be applied to one half of the face, either left or right side. The side the topical tretinoin will be applied to will be randomized.
OTHER	Placebo	A placebo (topical moisturizer) will be applied to the other half of the face, either left or right side. The side the topical tretinoin will be applied to will be randomized.

Timeline

• Start date: 2025-02-19
• Primary completion: 2027-07-01
• Completion: 2029-07-01
• First posted: 2024-04-10
• Last updated: 2026-02-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study