TAR-0520 Gel in EGFR Inhibitor-induced Folliculitis

Last updated: February 5, 2025
Sponsor: Tarian Pharma
Overall Status: Active - Recruiting

Phase

2

Condition

Acne

Soft Tissue Infections

Scalp Disorders

Treatment

Brimonidine tartrate Gel

Placebo gel (no Brimonidine tartrate)

Clinical Study ID

NCT06818058
TARIAN 007
2024-516339-28-00
  • Ages 18-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 betreated with cetuximab or panitumumab injections as part of the chemotherapyprotocol

  • patients who can understand and sign the Informed Consent Form, can communicate withinvestigator,can understand and comply with requierements of the protocol, and canapply 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 proceduralrequirements of the clinical trial protocol

Exclusion

Exclusion Criteria:

  • patients with medical history of EGFR treatment in the past 2 years

  • patients with any underlying physical ,psychological or medical condition that, inthe opinion of the invstigator, would make it unlikely that the patient will complywith the protocol or complete the study protocol

  • patients with any uncotrolled or serious disease, or any medical or surgicalcondition,that may put the subject at significant risk (according to theinvestigator's judgement) if he/she participates in the clinical trial

  • patients with history of other skin disorders (eg.atopicdermatitis,psoriasis,recurrent skin infections), or a history of illness that, inthe opinion of the investigator, would confound the results of the study

  • patients with significant skin disease other than EGFRi-induced folliculits withinthe same body areas planned for study drug application

  • patients with a beard that would interfere with administration of the study drug andassessement of study endpoints

  • patients with active infection within the treatment area ot in other body areas thatrequieres initiation of systemic antibiotics

  • patients with known or suspected allergies or sensitivities to any components of thestudy drugs

  • female patients who are pregnant or lactating

Study Design

Total Participants: 60
Treatment Group(s): 2
Primary Treatment: Brimonidine tartrate Gel
Phase: 2
Study Start date:
January 20, 2025
Estimated Completion Date:
September 30, 2026

Study 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.

Connect with a study center

  • Hopital Privé Jean Mermoz

    Lyon, 69008
    France

    Active - Recruiting

  • Institut Paoli Calmette

    Marseille, 13273
    France

    Active - Recruiting

  • Centre Antoine Lacassagne

    Nice, 06189
    France

    Site Not Available

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