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A study testing aprepitant gel for treating skin rash in cancer patients receiving epidermal growth factor receptor inhibitor therapy

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study is looking at skin problems that can happen when people receive certain cancer treatments called epidermal growth factor receptor inhibitors. These cancer medicines can cause skin reactions that look like acne, with bumps, pimples, and redness, along with itching and burning sensations. The treatment being tested is called HT-001, which is a gel that contains aprepitant and is applied directly to the skin. Some people in the study will receive HT-001 gel while others will receive placebo.

The purpose of this study is to see if HT-001 gel can help reduce these skin problems in people who develop them while taking cancer medicines. The study will also look at how safe the gel is and whether it causes any side effects. The study has two parts: the first part will check how much of the medicine gets into the body when applied to the skin, and the second part will compare different doses of HT-001 gel to placebo to see which works best.

People taking part in the study will use the gel for up to six weeks. During this time, they will have regular visits where doctors will check their skin reactions, ask about itching and pain, and monitor for any side effects. The doctors will take measurements of the skin problems, check vital signs like blood pressure and heart rate, do blood tests, and perform heart monitoring tests. The study will track whether the skin reactions improve, whether people need additional treatments for their skin, and whether they are able to continue their cancer treatment without having to lower the dose or stop because of skin problems.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment and assignment to study group

    Your medical condition will be assessed using two scales: the CTCAE grading (a system that measures side effects from cancer treatment) and the ARIGA scale (a specific assessment for skin rash). The severity of your rash should be grade 3 or less, affecting no more than 30% of your body surface area.

    Your overall health status will be evaluated using the ECOG performance status, which measures how your disease affects your daily living abilities. Your score should be between 0 and 2.

    You will be assigned to one of two parts of the study. Part 1 is an open-label group where both you and your doctor will know you are receiving the active medication. Part 2 is a randomized, double-blind group where you will receive either the active medication or placebo, and neither you nor your doctor will know which one you are receiving.

  2. Step 2

    Treatment application period

    You will apply HT-001 gel or placebo gel to your skin. The active ingredient in HT-001 is aprepitant. The placebo gel looks identical to HT-001 but does not contain the active ingredient.

    The treatment period will last for 6 weeks.

    The gel is applied directly to the skin (cutaneous use). Specific instructions regarding the amount and frequency of application will be provided to you during the study.

  3. Step 3

    Assessment at 3 weeks

    After 3 weeks of treatment, your skin rash will be assessed using the ARIGA scale to measure any changes from the beginning of the study.

    You will be asked to rate your itching using a numeric scale, including both your average itch and worst itch levels.

    You will be asked to rate any pain you are experiencing using a numeric scale.

    Your skin will be examined for signs of irritation, including redness and swelling, using a modified Draize Scale.

    Information will be collected about any side effects you may be experiencing.

    This visit may be conducted either in person or through telehealth, depending on the study requirements.

  4. Step 4

    Assessment at 6 weeks

    After 6 weeks of treatment, your skin rash will be assessed again using the ARIGA scale. The goal is to determine if your rash has improved to grade 1 or less.

    You will again rate your itching levels, including both average and worst itch.

    You will rate any pain you are experiencing.

    Your skin will be examined for signs of irritation, including redness and swelling.

    A physical examination will be performed.

    Your vital signs will be measured, including blood pressure, heart rate, and temperature.

    An electrocardiogram (a test that measures the electrical activity of your heart) will be performed.

    Blood and urine samples will be collected for laboratory testing. These tests will check your blood cell counts, kidney and liver function, and other important health markers.

    Information will be collected about any side effects you have experienced throughout the study.

    Information will be collected about whether you needed to reduce the dose of your cancer medication or stop it due to skin problems.

    Information will be collected about whether you needed to use any additional skin treatments during the study period.

  5. Step 5

    Pharmacokinetic assessment (Part 1 participants only)

    If you are assigned to Part 1 of the study, blood samples will be collected at specific times to measure how much of the medication enters your bloodstream after applying it to your skin.

    These measurements will include the maximum concentration (the highest amount of medication in your blood), the time to reach maximum concentration, and the area under the curve (a measure of total exposure to the medication over time).

  6. Step 6

    Ongoing monitoring throughout the study

    Throughout the 6-week treatment period, the time it takes for your rash to improve by at least one grade on the ARIGA scale will be recorded.

    The time until you need additional skin treatment will be recorded.

    Any changes to your cancer medication dose or schedule due to skin problems will be documented.

    All side effects, whether mild or serious, will be recorded throughout the study.

Who can join the trial?

11 criteria

  • You must be 18 years of age or older at the time of the first visit
  • You must be taking an approved epidermal growth factor receptor inhibitor, which is a type of cancer medicine that blocks signals that help cancer cells grow
  • Your cancer treatment must be according to approved guidelines for this type of medicine
  • You must have developed a rash or symptoms of a rash on your skin, such as small bumps, pus-filled bumps, or a burning feeling on your skin
  • The rash must cover 30% or less of your body surface area, meaning it affects less than one-third of your skin
  • The severity of your rash must be rated as grade 3 or lower according to standard medical rating scales
  • Your performance status must be rated between 0 and 2, which means you are able to care for yourself and perform light activities, even if you cannot do heavy physical work
  • Your doctors expect that you will live for at least 3 months
  • You must be able and willing to follow birth control requirements during the study
  • You must be able and willing to attend all required study visits, including visits by video call and visits in person
  • You must be willing and able to sign a consent form after the study has been explained to you and before any study procedures begin

Who cannot join the trial?

3 criteria

  • The study information does not list specific reasons why patients cannot participate in this clinical trial
  • If you are interested in this study, the research team will need to review your complete medical history to determine if you are eligible to take part
  • General factors that often prevent participation in clinical trials may include having certain other medical conditions, taking specific medications, or having allergies to study treatments, but these specific details are not provided in the available information
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Investigated drugs

HT-001 is an investigational topical medication being tested in this trial. It is applied directly to the skin to help treat and prevent skin rashes that look like acne. These rashes are a common side effect that can occur when patients take certain cancer medications called epidermal growth factor receptor inhibitors. The medication is being studied to see if it can reduce the severity of these skin reactions and help patients continue their cancer treatment more comfortably.

A placebo is used in this study as a comparison treatment. It looks the same as the active medication but does not contain any active ingredients. This helps researchers understand whether any improvements seen in patients are due to the actual medication or other factors.

What is already known about the treatment

HT-001 – HT-001 is an investigational topical medication currently being studied in clinical trials for the treatment of skin rashes that develop as a side effect of cancer drugs called epidermal growth factor receptor inhibitors. The medication is applied directly to the skin and is being tested to see if it can effectively reduce acneiform rash, a common skin reaction that looks similar to acne and occurs in patients receiving these cancer treatments. The study aims to determine the right dose of HT-001, how well it works in treating these skin problems, and whether it is safe and well-tolerated by patients. The exact way HT-001 works at the molecular level to prevent or treat these skin reactions is being investigated as part of this early-phase clinical research.

Investigated diseases

Skin Toxicities Associated with Epidermal Growth Factor Receptor Inhibitors – This condition refers to skin reactions that occur as a side effect of medications called epidermal growth factor receptor inhibitors, which are used in cancer treatment. The most common manifestation is an acneiform rash, which resembles acne and typically appears on the face, chest, and upper back. Patients may experience itching, pain, redness, and swelling in the affected areas. The rash usually develops within the first few weeks of starting the medication. The severity of skin reactions can vary from mild to severe, potentially affecting the patient's quality of life. In some cases, these skin problems may lead to reduction or discontinuation of the cancer medication.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-523058-16-00Protocol codeCLEER-001Estimated enrolment152 patientsSponsorHoth Therapeutics Inc.

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