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Topical Tretinoin for Skin Rash from Anti-EGFR Treatment

This study is testing if a cream called topical tretinoin can help prevent or reduce a common skin rash (acneiform rash) that can happen when patients with solid tumors are treated with anti-EGFR medications like panitumumab or cetuximab. Researchers will apply topical tretinoin to one side of your face and a plain moisturizer (placebo) to the other side. They will then compare the skin rash on both sides to see if tretinoin makes a difference. This study is for adults aged 18 and older with solid tumors that are locally advanced or have spread, and who are starting treatment with panitumumab or cetuximab. The main goal is to see the biggest difference in rash severity between the treated and untreated sides of your face within 6 weeks. The study is currently recruiting about 25 participants.

Study design
This is an interventional study where participants will be randomly assigned to have topical tretinoin applied to one side of their face and a placebo to the other. Approximately 25 participants are planned for this study.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured at up to 6 weeks from the initiation of study therapy.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06358677

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
University of Utah
~25 participants
Updated 2026-02-13 on ClinicalTrials.gov
What's tested:Topical TretinoinPlacebo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
The maximum difference in modified Investigators Global Assessment (IGA) score between the treated and untreated sides of the face at any assessment.
Measured over up to 6 weeks from the initiation of study therapy

Conditions

Metastatic Solid Tumor
Locally Advanced Solid Tumor

Explore related trials

Solid Neoplasm

NCT06358677

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Huntsman Cancer Institute at University of Utah

    Salt Lake City, Utahstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Christopher Nevala-Plagemann, MD · PRINCIPAL_INVESTIGATOR · Huntsman Cancer Institute

Who to contact

Susan Sharry
[email protected]
801-585-3453
Email the study team

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Eligibility criteria

Inclusion

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:
Amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments; or
Had radiation-induced menopause with last menses \>1 year ago; or
Had chemotherapy-induced menopause with last menses \>1 year ago; or
Underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy, or hysterectomy).
Participants of childbearing potential and participants with a sexual partner of childbearing potential must agree to use a highly effective method of contraception as described in Section 5.4.2.
Must have recovered from adverse effects of any prior oncologic treatment (e.g. prior surgery, radiotherapy, or other antineoplastic therapy). CTCAE adverse events less than or equal to grade 1 are acceptable. CTCAE adverse events grade 2 or greater may be acceptable as determined by an investigator with appropriate documentation.
Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.

Exclusion

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.

What this trial measures

  • The maximum difference in modified Investigators Global Assessment (IGA) score between the treated and untreated sides of the face at any assessment.up to 6 weeks from the initiation of study therapy

    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.