NCT06358677 Topical Tretinoin Prophylaxis for Anti-EGFR Induced Skin Toxicity in Patients With Solid Tumors
| NCT ID | NCT06358677 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of Utah |
| Condition | Metastatic Solid Tumor |
| Study Type | INTERVENTIONAL |
| Enrollment | 25 participants |
| Start Date | 2025-02-19 |
| Primary Completion | 2027-07 |
Trial Parameters
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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.
Eligibility Criteria
Inclusion Criteria: * 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 (bilate