RecruitingPHASE2INTERVENTIONAL

TAR-0520 Gel in EGFR Inhibitor-induced Folliculitis

This study is investigating a new gel called TAR-0520. It's designed for people with advanced bowel cancer who are receiving specific anti-cancer treatments, cetuximab or panitumumab. These treatments often cause a skin rash, known as folliculitis, on the face, upper body, and scalp. The main goals of the study are to check that the TAR-0520 gel is safe to use and to see if it can help prevent or reduce the severity of this rash. Currently, there isn't an approved treatment for preventing this specific rash. Participants will use the gel once a day for a week, followed by a break, over four cycles of their cancer treatment, lasting at least 56 days. This is a Phase II trial, meaning it's an early-stage study to gather more information.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Tarian Pharma

Enrolment target

Start

20 Jan 2025

Estimated completion

30 Sep 2026

EGFR Inhibitor-associated Rash

What is this study about?

If you have advanced bowel cancer and are being treated with specific anti-cancer medications called cetuximab or panitumumab, you might be interested in this study. These treatments are very effective for some people, but they often come with a side effect: a skin rash known as folliculitis. This rash, which looks a bit like acne, can appear on the face, upper body, and scalp, usually in the first few weeks of treatment. It can be uncomfortable and affect your daily life.

Currently, there isn't a specific approved medicine to prevent or treat this particular skin rash. That's why researchers are looking into new options. This study is testing a new gel, called TAR-0520, which has been developed to try and help with this problem.

The main aim of this study is to confirm that the TAR-0520 gel is safe for people with bowel cancer who are also receiving cetuximab or panitumumab. The study also wants to explore how well the gel works in preventing or reducing the severity of this skin rash. By understanding more about this gel, doctors hope to find a better way to manage this common side effect and improve the comfort of people undergoing cancer treatment.

Key takeaways

Tests a new gel (TAR-0520) for preventing a skin rash.
Aimed at people with advanced bowel cancer on specific treatments.
Checks gel safety and how well it reduces side effects.
Involves applying gel once daily for 7 days per treatment cycle.
Takes about 2 months, alongside your regular cancer treatment.
You might receive the active gel or a dummy (placebo) gel.

Who may be eligible?

To be considered for this study, you need to be at least 18 years old and have advanced bowel cancer. You must be planning to start treatment with cetuximab or panitumumab injections as part of your cancer care. It's important that you can understand the study information and give your permission to take part, and that you or someone close to you can apply the gel as instructed. The study also requires that you are expected to live for at least three more months and can commit to all the study appointments.

There are also some reasons why you might not be able to join. For example, if you've had similar anti-cancer treatment in the last two years, or if you have other serious health problems that the study doctors think would make it unsafe or difficult for you to participate. You also can't join if you have certain other skin conditions (like eczema or psoriasis) in the areas where the gel would be applied, or if you have a beard that would make applying the gel or checking your skin difficult.

If you have any active skin infections in the treatment area, or known allergies to any of the gel's ingredients, you wouldn't be able to join. Women who are pregnant or breastfeeding are also not able to participate in this study.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have advanced bowel cancer and are starting cetuximab or panitumumab?
Can you or a caregiver apply a gel to your skin?
Are you able to attend all study appointments?
Have you not had similar cancer treatment in the last 2 years?
Are you not pregnant or breastfeeding?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be assigned either the TAR-0520 gel or a 'dummy' gel (placebo) by chance – neither you nor the study team will know which you are receiving. You'll apply the gel once a day for seven days during the first week of each chemotherapy cycle. After this, you'll have a break from the gel until the next chemotherapy cycle starts, usually about seven days later. This process will repeat for four full chemotherapy cycles, meaning you'll be involved in the study for at least 56 days, or about two months, in total. Throughout this time, the study team will regularly check how your skin is doing and monitor your overall health to make sure the gel is safe and to see if it's helping with the rash.

Potential risks and benefits

Taking part in this study may offer some potential benefits. You would be among the first to try a new gel that might help prevent or reduce a common and uncomfortable skin rash caused by your cancer treatment. This could improve your comfort and quality of life during chemotherapy. However, there are also potential risks; the gel might not work, or you could experience side effects, though the study aims to confirm its safety. Your health will be closely monitored by the study team, and you are free to stop participating at any time, for any reason, without it affecting your usual medical care.

Locations (3)

Hopital Privé Jean Mermoz
Verified postcode
Lyon, France· Recruiting
Institut Paoli Calmette
Verified postcode
Marseille, France· Recruiting
Centre Antoine Lacassagne
Verified postcode
Nice, France· Not yet recruiting

Common questions

What is folliculitis?

Folliculitis is a skin rash that looks like small pimples, often accompanied by redness and discomfort, caused by inflammation around hair follicles.

What is a 'placebo gel'?

A placebo gel looks exactly like the active gel but contains no active medicine. It helps researchers understand if the active gel is truly making a difference.

Will I know if I'm getting the active gel or the placebo?

No, neither you nor the doctors will know which gel you are receiving during the study. This is called 'double-blind' and helps ensure fair results.

How long will I be in the study?

You will be in the study for at least 56 days, covering four cycles of your chemotherapy treatment.

What if I have other skin conditions?

If you have other significant skin conditions in the areas where the gel would be applied, you might not be able to participate, as it could affect the study's results.

How to find out more

Janusz Czernielewski, MD

janusz.czernielewski@tarianpharma.com +33680338274 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.