TAR-0520 Gel in EGFR Inhibitor-induced Folliculitis

Launched by TARIAN PHARMA · Feb 5, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new gel called TAR-0520, which is being tested to see if it can help prevent a skin condition called folliculitis that some patients develop while receiving treatment for metastatic colorectal cancer with specific medications. The trial will involve multiple locations and will include people aged 18 and older who are about to start treatment with drugs called cetuximab or panitumumab. Participants will be randomly assigned to either receive the TAR-0520 gel or a placebo (a gel that doesn't contain the active drug) to compare its effects.

To be eligible, individuals must have a confirmed diagnosis of metastatic colorectal cancer and be expected to live for at least three more months. They should be able to understand and follow the study instructions, which includes applying the gel themselves or having someone help them. However, people with certain skin conditions, serious health issues, or allergies to the gel's ingredients will not be able to participate. During the trial, participants will apply the gel as directed and will be monitored for any side effects or changes in their skin condition. It's a great opportunity to potentially benefit from a new treatment while contributing to important medical research.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • male or female, who is at least 18 years of age or older at the screening visit
• • patients with clinical diagnosis of metastatic colorectal carcinoma planned to be treated with cetuximab or panitumumab injections as part of the chemotherapy protocol
• • patients who can understand and sign the Informed Consent Form, can communicate with investigator,can understand and comply with requierements of the protocol, and can apply the study gel by himself/herself or have giver who can apply the product
• • patients with predicted life expectency of \> 3 months
• • patients willing and able to comply with all of the time commitements and procedural requirements of the clinical trial protocol
• Exclusion Criteria:
• • patients with medical history of EGFR treatment in the past 2 years
• • patients with any underlying physical ,psychological or medical condition that, in the opinion of the invstigator, would make it unlikely that the patient will comply with the protocol or complete the study protocol
• • patients with any uncotrolled or serious disease, or any medical or surgical condition,that may put the subject at significant risk (according to the investigator's judgement) if he/she participates in the clinical trial
• • patients with history of other skin disorders (eg.atopic dermatitis,psoriasis,recurrent skin infections), or a history of illness that, in the opinion of the investigator, would confound the results of the study
• • patients with significant skin disease other than EGFRi-induced folliculits within the same body areas planned for study drug application
• • patients with a beard that would interfere with administration of the study drug and assessement of study endpoints
• • patients with active infection within the treatment area ot in other body areas that requieres initiation of systemic antibiotics
• • patients with known or suspected allergies or sensitivities to any components of the study drugs
• • female patients who are pregnant or lactating