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A new topical gel called LUT014 successfully reduced the severity of a painful acne-like rash that commonly occurs as a side effect of targeted therapy with epidermal growth factor receptor (EGFR) inhibitors for colorectal cancer, according to a clinical trial led by researchers at The University of Texas MD Anderson Cancer Center.
Most patients who used the topical gel had improved quality of life and were able to continue receiving EGFR inhibitor treatment for their cancer compared to patients receiving a placebo gel, which can benefit long-term outcomes. Results from the Phase II trial were presented at the American Association of Cancer Research (AACR) Annual Meeting 2025 by principal investigator Anisha Patel, M.D., associate professor of Dermatology.
“We’re really excited about this novel topical gel. Having a therapy with low side effects and high efficacy is critical for improving quality of life and cancer treatment continuation for these patients, this rash can have a high impact on patients’ quality of life. Better control of the rash can lead to better control of the cancer and a better chance at significantly improving outcomes.”
Anisha Patel, M.D., associate professor of Dermatology.
The trial enrolled 118 patients with colorectal cancer across 23 medical centers who had developed moderate to severe acneiform rashes while taking an EGFR inhibitor. Patients were randomly assigned to receive a 0.1% formulation of LUT014, a 0.03% formulation of LUT014, or a placebo gel for 28 days.
Treatment success was defined as a one-grade or greater reduction in rash severity, or an improvement in at least five skin-specific quality-of-life criteria. Treatment success was significantly higher in patients who received either of the LUT014 formulations – 27 of 39 (69%) with the 0.1% formulation and 19 of 40 (47.5%) with the 0.03% formulation – compared to 13 of 39 (33%) in patients that received the placebo gel.
Notably, while patients receiving LUT014 still had some grade 3 or lower adverse events, these were considered an improvement on expected outcomes from the application of an alcohol-based gel on inflamed skin, with patients reporting better quality of life overall.
“These rashes typically are treated with antibiotics or topical steroids, but we’re seeing people develop resistance to those with long-term use,” Patel said.
“LUT014 is the first treatment to target the mechanism of the rash without being absorbed in the bloodstream, allowing us to effectively treat this unfortunate side effect without compromising tumor treatment. We saw results within a week for many of the patients.”
A Phase III clinical trial currently is in the works to further evaluate the effectiveness of this treatment, Patel explained. Additionally, while this study examined its use for colorectal cancer treatment, other cancer therapies currently in development also affect kinase pathways, highlighting the potential broader application of LUT014 to manage other types of cancer treatments.
The study was funded by Lutris Pharma. Patel reports receipt of consulting fees from Asymmetric Therapeutics, Deciphera Pharmaceuticals, Erasca, Janssen Scientific Affairs, Lutris Pharma, OnQuality Pharmaceuticals, Repare Therapeutics and SynOx Therapeutics, as well as research funding to MD Anderson from AnaptysBio, Hoth Therapeutics, Lutris Pharma, OnQuality Pharmaceuticals and Pfizer.
(Newswise/FS)
