Centre Hospitalier Universitaire De Bordeaux
Bordeaux, France
RecruitingDrug eruptionRare disease
Title: Study of TAR-0520 gel for skin rash (folliculitis) caused by cancer treatment with EGFR inhibitors in colorectal cancer patients
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What is this trial about?
A plain-language summary of the goals, design and what participants do
This study focuses on treating EGFR inhibitor-induced folliculitis, a skin condition that occurs as a side effect in patients receiving cancer treatments called EGFR inhibitors. This condition typically appears as an acne-like rash on the face and chest of patients who are receiving treatments such as cetuximab or panitumumab for colorectal cancer.
The research evaluates a new medication called TAR-0520 gel, which contains brimonidine tartrate as its active ingredient. This gel is designed to be applied directly to the skin of the face and chest. The study aims to confirm that this treatment is well-tolerated by patients who are experiencing skin reactions from their cancer treatment.
During the study, participants will use either TAR-0520 gel or a placebo gel on their skin for 28 days. The gel needs to be applied to affected areas of the face and chest, with a maximum daily amount of 1.6 grams. The total amount of gel used throughout the entire treatment period will not exceed 44.8 grams.
The research process
The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.
Who can join the trial?
5 criteria
- Age: Must be 18 years or older at the time of screening visit
- Gender: Both men and women can participate
- Diagnosis: Must have metastatic colorectal carcinoma (cancer that has spread from the colon or rectum to other parts of the body)
- Treatment plan: Must be scheduled to receive either cetuximab or panitumumab (medications that target cancer cells) as part of chemotherapy treatment
- Patient type: Must be able to provide informed consent and not be part of a vulnerable population
Who cannot join the trial?
10 criteria
- Patients under 18 years of age
- Patients with known allergies to any components of TAR-0520 gel
- Patients not currently receiving treatment with anti-EGFR antibodies (medications that target a specific protein involved in cancer growth)
- Patients with open wounds or infections on the face or chest area where the gel would be applied
- Patients with severe skin conditions other than EGFR inhibitor-induced folliculitis (skin rash caused by cancer treatment)
- Pregnant or breastfeeding women
- Patients participating in other clinical trials
- Patients unable to follow study procedures or attend follow-up visits
- Patients with known hypersensitivity to topical medications
- Patients using other treatments for skin rash without approval from the study doctor
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Verified sites
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Verified Verified Centre Hospitalier Universitaire Reims
Reims, FranceVerified Hopital Beaujon
Clichy, France
Trial locations
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Investigated drugs
TAR-0520 is a topical gel medication being studied for treating skin problems (folliculitis) that occur as a side effect in cancer patients who are receiving EGFR inhibitor therapy. The gel is designed to be applied to the face and chest areas. It aims to help manage the skin inflammation and rash that commonly develops in patients receiving certain types of cancer treatments, specifically those targeting EGFR (Epidermal Growth Factor Receptor).
What is already known about the treatment
TAR-0520 gel – A topically applied medication currently undergoing Phase 2a clinical trials for the treatment of EGFR inhibitor-induced folliculitis in cancer patients. This gel formulation is specifically designed to be applied to the face and chest areas of patients who experience skin reactions as a side effect of anti-EGFR antibody therapy used in colorectal cancer treatment. While the exact mechanism of action is still under investigation in clinical trials, the primary focus is on evaluating the local tolerance and effectiveness in managing folliculitis symptoms that occur during cancer treatment. The medication represents a targeted approach to managing dermatological side effects of cancer therapy, with ongoing research to establish its safety profile and therapeutic efficacy.
Investigated diseases
EGFR inhibitor-induced folliculitis - A skin condition that develops as a side effect of EGFR inhibitor therapy, characterized by inflammation of hair follicles primarily affecting the face and chest. The condition typically appears within the first few weeks of treatment, presenting as red, pus-filled bumps that resemble acne. It commonly causes itching, tenderness, and burning sensations in the affected areas. The severity of folliculitis can vary from mild eruptions to more extensive involvement of the skin.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-516339-28-00Protocol codeTARIAN 007Estimated enrolment60 patientsSponsorTarian Pharma
sourced from the EU Clinical Trials Register and site verification
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