A Randomized, Placebo-controlled, Parallel Phase 2a Dose-ranging Study to Investigate the Efficacy, Safety, and Tolerability of Topical HT-001 for the Treatment of Skin Toxicities Associated with Epidermal Growth Factor Receptor Inhibitors CLEER Trial (Chemotherapy Longevity by Evading EGFR Inhibitor Reactions)
This research study, called the CLEER Trial, is investigating a new cream, HT-001, for skin side effects caused by certain cancer treatments. These cancer treatments, called EGFR inhibitors, can sometimes lead to skin issues like rashes. The study aims to find out how well HT-001 works to improve these skin problems and reduce discomfort like itching. It also wants to make sure the cream is safe and doesn't cause new problems. Participants will either receive the active cream or a dummy cream (placebo). The study has two parts: one to see how the cream is absorbed by the body, and another to compare the cream's effects to the dummy cream over several weeks.
At a glance
What is this study about?
This study is looking into a new cream called HT-001. It's designed to help people who are having skin problems because of certain cancer medications. These specific cancer drugs, known as EGFR inhibitors, are helpful for treating cancer but can sometimes cause side effects like rashes, itching, and dryness on the skin.
The main goal of this study is to see if the HT-001 cream can effectively lessen these skin issues. Researchers will also be checking to make sure the cream is safe to use and doesn't cause any serious side effects. They want to understand how the cream works and if it can make a real difference to people's quality of life while they are on their cancer treatment.
This study is important because managing these skin side effects can sometimes be very uncomfortable for patients, and in some cases, it might even lead to changes in their cancer treatment. By finding an effective way to relieve these skin problems, patients might be able to continue their important cancer therapy with fewer difficulties.
Key takeaways
- This study is for skin problems caused by certain cancer drugs called EGFR inhibitors.
- It's testing a new cream, HT-001, to see if it helps reduce symptoms like rash and itching.
- Participation involves using the cream (or a dummy cream) for about 6 weeks and regular check-ups.
- Researchers will check how safe the cream is and how well it works.
- The study aims to improve comfort for patients undergoing specific cancer treatments.
Who may be eligible?
To join this study, participants must be at least 18 years old. Both men and women are welcome to take part.
You would need to be currently experiencing skin problems that are related to your epidermal growth factor receptor (EGFR) inhibitor cancer treatment. The research team will check to make sure your skin issues match what they are looking for in the study.
There might be other health conditions or medications that would prevent someone from joining, so a doctor or nurse from the study will discuss all the requirements with you to see if it's a good fit.
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?
- Are you currently taking an EGFR inhibitor cancer medicine?
- Are you experiencing skin side effects (like a rash or itching) from this medicine?
- Are you able to attend regular clinic appointments for about 6 weeks?
What does participation involve?
If you decide to take part in this study, you would first have a check-up to make sure you're suitable. The study has two parts. The first part is for a small group of people where doctors will check how the cream is absorbed into your body.
The second, larger part of the study involves using the HT-001 cream or a dummy cream (placebo) on your skin. You won't know which one you're getting, and neither will the study doctors, until the study is over. You'll apply the cream regularly for about 6 weeks. During this time, you'll have several visits to the clinic where doctors will check your skin, measure any changes in itching or pain, and do various tests like blood tests, physical exams, and possibly an ECG (heart tracing).
Throughout the study, doctors will keep a close eye on any side effects you might experience. They will also look at whether your cancer treatment dose needed to be changed because of your skin problems. The total duration of your active involvement in the study will be around 6 weeks, with some follow-up checks thereafter.
Potential risks and benefits
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Common questions
What are EGFR inhibitors?
EGFR inhibitors are a type of medicine used to treat some cancers. They work by blocking signals that help cancer cells grow, but they can sometimes cause skin problems as a side effect.
What is HT-001?
HT-001 is a new cream being tested to help soothe and treat skin problems that can happen when you're taking EGFR inhibitor medicines for cancer.
What is a 'placebo'?
A placebo is a 'dummy' cream that looks exactly like the real cream but doesn't contain any active medicine. It helps researchers compare the real cream's effects.
How long will I be in the study?
If you join the main part of the study, you'll use the cream and have check-ups for about 6 weeks, with some follow-up after that.
Can I stop taking part if I want to?
Yes, you can leave the study at any time, for any reason, and it won't affect your regular medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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