Clinical trial NCT06818058: TAR-0520 Gel in EGFR Inhibitor-induced Folliculitis
Official title: A Phase II Multicentric, Randomized, Double-blind, Placebo-controlled Study of TAR-0520 Gel in EGFR Inhibitor-induced Folliculitis.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: EGFR Inhibitor-associated Rash
Keywords: EGFR inhibitor-induced skin rash;
EGFR inhibitor-induced folliculitis
Lead sponsor: Tarian Pharma
Sponsor class: INDUSTRY
First posted: 2025-02-10
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Frequency of Treatment - emergent Advers Events (TEAEs)
timeFrame: At Baseline and then at Day 14, Day 28, Day 42 and Day 56 .
Secondary outcomes:
measure: Efficacy of TAR-0520 gel to prevent EGFR-induced folliculits
timeFrame: The measurements will be performed at Baseline visit and then at Day 14,Day 28,Day 42 and Day 56.
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hopital Privé Jean Mermoz
city: Marseille
country: France
facility: Institut Paoli Calmette
city: Nice
country: France
facility: Centre Antoine Lacassagne
Study officials:
References: