A Phase 2 interventional study of Brimonidine tartrate Gel and Placebo gel (no Brimonidine tartrate) in EGFR Inhibitor-associated Rash, sponsored by Tarian Pharma. Recruiting at 3 sites in France. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-02-10.
Sponsored by Tarian Pharma · Phase 2, Interventional, and Prevention
A Phase II, multicentric, randomized, double-blind, placebo-controlled, parallel- group trial to confirm the good safaty profile and to explore the preventive effect of topically applied TAR-0520 gel on folliculitis developed in metastatic colorectal cancer (mCRC) patients treated with monoclonal anti-EGFR antibodies.
Cetuximab and panitumumab hae become the standard treatment for patients with metastatic colorectal cancer without RAS gene mutation. Hoever, these EGFR inhbitors induce a broad spectrum of cutaneous toxicities (skin side effects) in 75-90% of patients, including the folliculitis involving the face,upper torso and scalp. The folliculitis appears within 1-2 weeks of anti-EGFR therapy and peaks around 3-5 weeks of treatment. There is no approved treatment to prevent or treat EGFR-induced folliculitis. Tarian Pharma has developed a new topical treatment of EGFRi-induced folliculitis.This study aims to confirm the good safety of TAR-0520 gel in colorectal cancer patients treated with cetuximab or panitmumab and eplore , in the same patients , the effect of TAR-0520 gel on the extent and severity of EGFRi-induced folliculitis.
Patients aged 18 years and over with metastatic colorectal carcinoma planned to be treated with cetuximab or panitumumab injections will be included in the study.
Participants will be randomly allocated to receive either the topical active TAR-0520 gel or its vehicle.The study will include a 7days treatment period with once daily applications of the test product followed by a treatment free period until the start of the next chemotherapy cycle usually 7 days later.The study will cover 4 complete chemotherapy cycles, thus lasting at least 56 days.
Exclusion Criteria:
Brimonidine tartrate gel
Drug: Brimonidine tartrate Gel
Drug: Placebo gel (no Brimonidine tartrate)
Once daily applications for 7 days
Once daily applications for 7 days
Frequency of Treatment - emergent Advers Events (TEAEs)
TEAEs will be tabulated in frequency tables by System Organ Class and Preferred Term, based on the Medical Dictionary for Regulatory Activities (MedDRA). Additional summary tables will be provided for AEs that are considered serious (SAEs), related to the study drug, adverse events of special interest (AESIs), and AEs leading to discontinuation. The safety conclusions will be based on the comparative analysis of the AEs reported in the two treatment arms.
Time frame: At Baseline and then at Day 14, Day 28, Day 42 and Day 56 .
Efficacy of TAR-0520 gel to prevent EGFR-induced folliculits
The preventive effectivness of TAR-0520 gel will be measured by assessing EGFR-induced folliculitis severity using a modified Common Terminology Criteria for Adverse Events (CTCAE) scale (Grade 0-no folliculitis - Grade 4-severe folliculitis)
Time frame: The measurements will be performed at Baseline visit and then at Day 14,Day 28,Day 42 and Day 56.
Plan to share: No
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Folliculitis