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 study about?

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.

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 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 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 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 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 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 Study?

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 Study?

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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Hospital Universitario Hm Sanchinarro	Madrid	Spain
Niepubliczny Zaklad Opieki Zdrowotnej Neuromed M. I M. Nastaj. sp.p.	Lublin	Poland
Futuremeds Sp. z o.o.	Wroclaw	Poland

Other Sites

Site Name	City	Country
Zanamed Medical Clinic Sp. z o.o.	Lublin	Poland
Fundacion Instituto Valenciano De Oncologia	Valencia	Spain
Althaia Xarxa Assistencial Universitaria De Manresa Fundacio Privada	Manresa	Spain
Ars Medical Sp. z o.o.	Pila	Poland
Pratia Hematologia Sp. z o.o.	Katowice	Poland
Hospital Clinic De Barcelona	Barcelona	Spain
Semmelweis University	Budapest	Hungary
Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy	Warsaw	Poland
Hospital Universitari Arnau De Vilanova De La Gerencia Territorial De Lleida	Lleida	Spain
Hospital Universitario Virgen De Valme	Sevilla	Spain
Pratia S.A.	Skorzewo	Poland
Hngvcxll Sldse Cwmrlgmv Iom	Salt	Spain
Hcnvhezg Uyqmwsjrczprd Mbfbbtg Do Vwpwtiqbrt	Santander	Spain
Djyjkhzlneru Cjgwhsh Oyddvwmca Pclwfohjsrdh I Hfvxyeuzamh	Wroclaw	Poland
Nfypvi Vksgnjrjr Sdibc Lczqj Kvarth	Salgotarjan	Hungary
Bbhpxrgcurm Vpwjlzmlj Ojqhjurzgbrm	Kecskemet	Hungary
Noxvlgwc Ieuwfspe Oeupidrbk Imz Macdu Smfppnhyfisshxowsuacxnbepwcg Ivhaslhw Bobowptb	Cracow	Poland

Trial status

Country	Status	Recruitment Start
Hungary	Not yet recruiting	08.01.2026
Poland	Recruiting	08.01.2026
Spain	Recruiting	08.01.2026

Trial locations

Investigated drugs:

Aprepitant

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.

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 ID:

2025-523058-16-00

Protocol code:

CLEER-001

NCT ID:

NCT05639933

Trial Phase:

Therapeutic exploratory (Phase II)

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

What is this study about?

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Who Cannot Join the Study?