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Study comparing bilastine, ebastine, and desloratadine in preventing histamine-induced skin reactions in healthy volunteers

Verified siteRegistered drugNo placebo
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What is this trial about?

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

This study examines how effectively different antihistamine medications prevent skin reactions caused by histamine. The medications being tested are bilastine 20 mg, ebastine 10 mg, and desloratadine 5 mg, all in dissolving tablet form, compared to placebo. The purpose is to determine how quickly these medications start working to reduce skin reactions.

The medications are designed to treat allergies by blocking the effects of histamine in the body. Each medication is taken by mouth in the form of a tablet that dissolves on the tongue. During the study, participants will receive each of the three medications and placebo at different times, with appropriate breaks between treatments.

The study will measure how well each medication prevents the development of raised, itchy bumps and redness on the skin after histamine exposure. Researchers will monitor participants' reactions at various time points after taking the medication to understand how quickly each drug starts working, how long the effects last, and how strong the effects are compared to placebo.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment day

    You will receive one of four treatments: placebo (inactive substance), desloratadine (5 mg), ebastine (10 mg), or bilastine (20 mg) in tablet form that dissolves in the mouth

    A small amount of histamine will be applied to your skin to measure your skin's reaction

    Medical staff will measure the size of any skin reaction (wheal and redness) at specific time points

    Your sensation of itching will be evaluated using a rating scale

    Blood samples will be collected to measure drug levels in your body

  2. Step 2

    Waiting period

    A period of time will pass to ensure the previous treatment is completely eliminated from your body

  3. Step 3

    Subsequent treatment days

    You will repeat the process three more times, receiving a different treatment each time

    The same measurements of skin reaction and blood samples will be taken

    Each visit will follow the same procedure as the first treatment day

  4. Step 4

    Safety monitoring

    Throughout the study, your vital signs (blood pressure, temperature, heart rate) will be monitored

    Laboratory tests will be performed to ensure your safety

    Any side effects will be recorded and evaluated

  5. Step 5

    Study completion

    Final health checks will be performed

    Laboratory tests will be conducted to ensure your well-being

    Your participation in the study will end after all four treatment sessions are completed

Who can join the trial?

10 criteria

  • Must sign an informed consent form agreeing to participate in the study
  • Must avoid excessive sun exposure or any procedures that could change skin color
  • Must be between 18 and 50 years old
  • Must not have any physical or mental health conditions
  • Must have normal results from medical examination and health records review
  • Must have normal blood test results, including tests for hepatitis B, hepatitis C, and HIV
  • Must have normal vital signs (blood pressure, temperature, heart rate) and normal heart rhythm test (ECG)
  • Must have a body mass index (BMI) between 18.5 and 30.0 kg/m² (a measurement of body fat based on height and weight)
  • Women who can become pregnant must use barrier contraception methods during the study and for one week after. Hormone-based birth control methods are not allowed
  • Must have specific skin reaction results to histamine testing (a substance that causes allergic reactions) within the required range of 0.5521 cm² to 2.5941 cm²

Who cannot join the trial?

15 criteria

  • History of severe allergic reactions or anaphylaxis (life-threatening allergic reactions)
  • Current use of antihistamine medications (allergy medications) within the past week
  • Known hypersensitivity (allergic reaction) to bilastine, ebastine, or desloratadine
  • Pregnancy or breastfeeding
  • Significant medical conditions that could interfere with the study results
  • Current participation in other clinical trials or within the past 30 days
  • History of drug or alcohol abuse within the past 2 years
  • Inability to follow study instructions or complete all required visits
  • Any condition that could affect the absorption of oral medications
  • Use of medications that might interact with the study drugs
  • History of chronic respiratory conditions (long-term breathing problems)
  • Abnormal vital signs or laboratory test results that are clinically significant
  • Mental health conditions that could affect the ability to provide informed consent
  • History of severe cardiovascular disease (heart problems)
  • Liver or kidney function problems
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Investigated drugs

  • Bilastine

    is an antihistamine medication that helps reduce allergy symptoms. It works by blocking histamine, a substance in the body that causes allergic reactions. This medication comes in an orodispersible form, which means it dissolves quickly in your mouth.

  • Ebastine

    is an antihistamine that helps relieve allergy symptoms such as sneezing, runny nose, and itchy eyes. It works by preventing histamine from causing allergic reactions in your body. This medication comes in a form that dissolves in your mouth.

  • Desloratadine

    is an antihistamine medication that treats allergy symptoms by blocking the effects of histamine in your body. Like the other medications in this trial, it comes in an orodispersible form that dissolves quickly when placed on your tongue.

What is already known about the treatment

  • Bilastine

    A second-generation antihistamine medication administered as an orodispersible tablet that dissolves quickly in the mouth. This drug works by blocking histamine H1 receptors, effectively reducing allergic symptoms such as sneezing, itching, and hives. Bilastine belongs to the class of selective antihistamines and is primarily used to treat seasonal allergies and urticaria, with a rapid onset of action and minimal sedative effects.

  • Ebastine

    An oral lyophilized antihistamine medication that quickly dissolves when placed on the tongue. This second-generation antihistamine works by selectively blocking H1 histamine receptors, providing relief from allergy symptoms without significant drowsiness. Ebastine is commonly prescribed for allergic rhinitis and chronic urticaria, with its active form carebastine providing long-lasting symptom relief.

  • Desloratadine

    An orodispersible antihistamine tablet that dissolves rapidly in the mouth, making it easy to take without water. This medication is a metabolite of loratadine and functions as a long-acting, selective H1-receptor antagonist that effectively reduces allergy symptoms. Desloratadine is widely used in the treatment of allergic conditions such as hay fever and hives, offering relief with minimal sedation and once-daily dosing.

Investigated diseases

Allergy - A condition where the immune system reacts abnormally to substances (allergens) that are usually harmless to most people. When an allergic person encounters specific allergens, their body releases chemicals like histamine, causing symptoms such as sneezing, itching, rashes, and swelling. The reaction can occur immediately or within a few hours after exposure to the allergen. Allergies can affect various parts of the body, including the skin, respiratory system, and digestive tract. The severity of allergic reactions can vary from mild discomfort to more intense symptoms, and people may be allergic to multiple substances.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-516569-35-00Estimated enrolment26 patientsSponsorA. Menarini Industrie Farmaceutiche Riunite S.r.l.

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).