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

NCT06358677 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: HCI171997
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Metastatic Solid Tumor; Locally Advanced Solid Tumor

Outcome Measures

Primary Outcomes (1)

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

  Effect of topical tretinoin on anti-EGFR induced acneiform rash. Rash will be scored from 0-4 with 0 being clear skin and 4 being a severe rash.

  up to 6 weeks from the initiation of study therapy

Secondary Outcomes (2)

• 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.

  up to 6 weeks from the initiation of study therapy

• Proportion of acneiform rash per CTCAE v5.0

  up to 6 weeks from the initiation of study therapy

Study Arms (2)

Tretinoin half of face (left) and Placebo/Moisturizer other half of the face (right)

EXPERIMENTAL

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.

Drug: Topical Tretinoin

Tretinoin half of face (right) and Placebo/Moisturizer other half of the face (left)

EXPERIMENTAL

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.

Other: Placebo

Interventions

Topical Tretinoin DRUG

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.

Tretinoin half of face (left) and Placebo/Moisturizer other half of the face (right)

Placebo OTHER

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.

Also known as: Topical Moisturizer

Tretinoin half of face (right) and Placebo/Moisturizer other half of the face (left)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant aged ≥ 18 years
• Histologically confirmed solid tumor.
• Radiologically confirmed locally advanced or metastatic disease.
• Eligible for and willing to receive treatment with panitumumab or cetuximab as standard-of-care.
• ECOG Performance Status ≤ 2.
• Adequate organ function as defined as:
• Hepatic:
• Total Bilirubin ≤ 1.5x institutional upper limit of normal (ULN)
• AST(SGOT)/ALT(SGPT) ≤ 3 × institutional ULN ----Participants with liver metastases will be allowed to enroll with AST and ALT levels ≤ 5 x ULN.
• Negative pregnancy test for participants who have not undergone surgical sterilization or shown evidence of post-menopausal status. The following age-specific requirements apply:
• \< 50 years of age:
• Amenorrheic for ≥ 12 months following cessation of exogenous hormonal treatments; and
• Luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution; or
• Underwent surgical sterilization (bilateral oophorectomy or hysterectomy).
• ≥ 50 years of age:

You may not qualify if:

• Treatment with an anti-EGFR agent within 90 days of registration.
• Pre-existing facial rash that per the treating investigator would preclude the ability to assess response to topical tretinoin.
• The diagnosis of another malignancy within ≤ 2 years before study enrollment, except for those considered to be adequately treated with no evidence of disease or symptoms and/or will not require therapy during the study duration (i.e., basal cell or squamous cell skin cancer, carcinoma in situ of the breast, bladder or of the cervix, or low-grade prostate cancer with Gleason Score ≤ 6).
• Any other condition that would, in the Investigator's judgment, contraindicate the participant's participation in the clinical study due to safety concerns or compliance with clinical study procedures.
• Systemic active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination, radiographic findings, and TB testing in line with local practice), hepatitis B (known positive HBV surface antigen (HBsAg) result), or hepatitis C.
• Note: Participants with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody \[anti-HBc\] and absence of HBsAg) are eligible. Participants positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA.
• Medical, psychiatric, cognitive, or other conditions that may compromise the participant's ability to understand the participant information, give informed consent, comply with the study protocol or complete the study.
• Known prior severe hypersensitivity to investigational product or any component in its formulations (CTCAE v5.0 Grade ≥ 3).
• Participants taking prohibited medications as described in Section 6.8.2. A washout period of prohibited medications for a period of at least five half-lives or as clinically indicated should occur before the start of treatment.

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

Huntsman Cancer Institute at University of Utah

Salt Lake City, Utah, 84112, United States

RECRUITING

Related Publications (20)

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MeSH Terms

Conditions

Neoplasm Metastasis

Interventions

Tretinoin

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Vitamin A; Retinoids; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Diterpenes; Pigments, Biological; Biological Factors

Study Officials

• Christopher Nevala-Plagemann, MD

  Huntsman Cancer Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Susan Sharry

CONTACT

801-585-3453; susan.sharry@hci.utah.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 4, 2024
• First Posted: April 10, 2024
• Study Start: February 19, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2029
• Last Updated: February 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)