TAR-0520 Gel in EGFR Inhibitor-induced Folliculitis

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: EGFR Inhibitor-associated Rash

In brief

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.

Key facts

Study ID

NCT06818058

Run by

Tarian Pharma

People needed

60

Starts

2025-01-20

Expected to finish

2026-09-30

Last updated by the study team

2025-02-10

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Hopital Privé Jean Mermoz — Lyon, France (enrolling)
• Institut Paoli Calmette — Marseille, France (enrolling)
• Centre Antoine Lacassagne — Nice, France

Full record on ClinicalTrials.gov

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