TAR-0520 Gel in EGFR Inhibitor-induced Folliculitis

NCT ID: NCT06818058

Last Updated: 2025-02-10

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-20
• Study Completion Date: 2026-09-30

Brief Summary

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.

Detailed Description

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.

Conditions

EGFR Inhibitor-associated Rash

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Active arm

Brimonidine tartrate gel

Group Type: EXPERIMENTAL

Brimonidine tartrate Gel

Intervention Type: DRUG

Once daily applications for 7 days

Placebo arm

Group Type: PLACEBO_COMPARATOR

Placebo gel (no Brimonidine tartrate)

Intervention Type: DRUG

Once daily applications for 7 days

Interventions

Brimonidine tartrate Gel

Once daily applications for 7 days

Intervention Type: DRUG

Placebo gel (no Brimonidine tartrate)

Once daily applications for 7 days

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tarian Pharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hopital Privé Jean Mermoz

Lyon, , France

Site Status: RECRUITING

Institut Paoli Calmette

Marseille, , France

Site Status: RECRUITING

Centre Antoine Lacassagne

Nice, , France

Site Status: NOT_YET_RECRUITING

Countries

France

Central Contacts

Janusz Czernielewski, MD

Role: CONTACT

janusz.czernielewski@tarianpharma.com

+33680338274

Alexandra Lamquin, PhD

Role: CONTACT

alexandra.lamquin@tarianpharma.com

Facility Contacts

Pascal Artru, MD

Role: primary

dr.artru@wanadoo.fr

+33437538726

Emmanuel Mitry, MD

Role: primary

mitryje@ipc@unicancer.fr

+33 491223302

Ludovic Evesque, MD

Role: primary

ludovic.evesque@nice.unicancer.fr

+33 492031352

Other Identifiers

2024-516339-28-00

Identifier Type: CTIS

Identifier Source: secondary_id

TARIAN 007

Identifier Type: -

Identifier Source: org_study_id