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

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What is this study about?

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.

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 Waiting period

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

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 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 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 Study?

  • 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 Study?

  • 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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name City Country Status
Fundacio Institut De Recerca De L’Hospital De La Santa Creu I Sant Pau Barcelona Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Spain Spain
Not recruiting
01.04.2025

Trial locations

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.

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 ID:
2024-516569-35-00
Trial Phase:
Therapeutic confirmatory (Phase III)

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