Title: Study of TAR-0520 gel for skin rash (folliculitis) caused by cancer treatment with EGFR inhibitors in colorectal cancer patients

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What is this study about?

This study focuses on treating EGFR inhibitor-induced folliculitis, a skin condition that occurs as a side effect in patients receiving cancer treatments called EGFR inhibitors. This condition typically appears as an acne-like rash on the face and chest of patients who are receiving treatments such as cetuximab or panitumumab for colorectal cancer.

The research evaluates a new medication called TAR-0520 gel, which contains brimonidine tartrate as its active ingredient. This gel is designed to be applied directly to the skin of the face and chest. The study aims to confirm that this treatment is well-tolerated by patients who are experiencing skin reactions from their cancer treatment.

During the study, participants will use either TAR-0520 gel or a placebo gel on their skin for 28 days. The gel needs to be applied to affected areas of the face and chest, with a maximum daily amount of 1.6 grams. The total amount of gel used throughout the entire treatment period will not exceed 44.8 grams.

1 Initial assessment

You will receive a medical assessment to confirm your eligibility for the study if you are 18 years or older and have been diagnosed with metastatic colorectal cancer

The assessment will verify that you are scheduled to receive cetuximab or panitumumab as part of your chemotherapy treatment

2 Treatment assignment

You will be assigned to receive either TAR-0520 Gel (containing brimonidine tartrate) or a matching gel without active ingredients

The gel will be for topical use, which means applying it to your skin on the face and chest areas

3 Treatment period

You will apply the assigned gel to your face and chest during the course of your anti-EGFR antibody treatment

Your skin condition will be monitored regularly for any skin reactions (folliculitis) that may develop during treatment

Medical staff will assess the severity of any skin reactions using specific evaluation scales

4 Monitoring and evaluation

Regular assessments will track any side effects that may occur during the treatment

You will complete questionnaires about your experience with the treatment

Medical staff will monitor the severity of any skin reactions on your face

5 Study completion

The study is expected to continue until September 2026

Your participation will end once you complete your prescribed treatment period

Who Can Join the Study?

Age: Must be 18 years or older at the time of screening visit
Gender: Both men and women can participate
Diagnosis: Must have metastatic colorectal carcinoma (cancer that has spread from the colon or rectum to other parts of the body)
Treatment plan: Must be scheduled to receive either cetuximab or panitumumab (medications that target cancer cells) as part of chemotherapy treatment
Patient type: Must be able to provide informed consent and not be part of a vulnerable population

Who Cannot Join the Study?

Patients under 18 years of age
Patients with known allergies to any components of TAR-0520 gel
Patients not currently receiving treatment with anti-EGFR antibodies (medications that target a specific protein involved in cancer growth)
Patients with open wounds or infections on the face or chest area where the gel would be applied
Patients with severe skin conditions other than EGFR inhibitor-induced folliculitis (skin rash caused by cancer treatment)
Pregnant or breastfeeding women
Patients participating in other clinical trials
Patients unable to follow study procedures or attend follow-up visits
Patients with known hypersensitivity to topical medications
Patients using other treatments for skin rash without approval from the study doctor

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France

Other Sites

Site Name	City	Country
Centre Antoine Lacassagne	Nice	France
Hopital Europeen Marseille	Marseille	France
Hopital Prive Jean Mermoz	Lyon	France
Hopital Saint Joseph	Marseille	France
Hopital Beaujon	Clichy	France
Institut Sainte Catherine	Avignon	France
Crmtaw Hbidafzlrmq Uvivphfqajaep Rhcog	Reims	France
Czygtv Alzypmz dd Cdkxaqtuibyh	Mougins	France
Czpear dn Ryyxooxllbirp &kxtgle Cydnpcni Srqqgq Agav	STRASBOURG, Alsace	France
Iickchkk Pflchdagugsvnmi Cmzztz Cjkmfu	Marseille	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	15.10.2024

Trial locations

Investigated drugs:

Brimonidine Tartrate

TAR-0520 is a topical gel medication being studied for treating skin problems (folliculitis) that occur as a side effect in cancer patients who are receiving EGFR inhibitor therapy. The gel is designed to be applied to the face and chest areas. It aims to help manage the skin inflammation and rash that commonly develops in patients receiving certain types of cancer treatments, specifically those targeting EGFR (Epidermal Growth Factor Receptor).

EGFR inhibitor-induced folliculitis – A skin condition that develops as a side effect of EGFR inhibitor therapy, characterized by inflammation of hair follicles primarily affecting the face and chest. The condition typically appears within the first few weeks of treatment, presenting as red, pus-filled bumps that resemble acne. It commonly causes itching, tenderness, and burning sensations in the affected areas. The severity of folliculitis can vary from mild eruptions to more extensive involvement of the skin.

Trial ID:

2024-516339-28-00

Protocol code:

TARIAN 007

Trial Phase:

Therapeutic exploratory (Phase II)

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Title: Study of TAR-0520 gel for skin rash (folliculitis) caused by cancer treatment with EGFR inhibitors in colorectal cancer patients

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?