Study on Allergenic Extracts of Mites and Histamine Dihydrochloride for Allergy Patients

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What is this study about?

This clinical trial is focused on studying allergies caused by certain types of mites. The trial will use skin-prick tests, which involve applying a small amount of a substance to the skin to see if it causes a reaction. The substances being tested include extracts from different types of mites: Dermatophagoides pteronyssinus, Dermatophagoides farinae, Blomia tropicalis, and Lepidoglyphus destructor. These extracts are compared to a solution of histamine dihydrochloride, which is commonly used in allergy testing.

The purpose of the study is to determine the biological activity of these mite extracts in patients who are sensitive to them. This means the study aims to find out how strong the reaction is when these extracts are used in a skin-prick test. The study will involve applying these extracts to the skin and observing the size of the reaction, or wheal, that forms. This will help in standardizing the extracts in terms of their biological activity, measured in Histamine Equivalent Units (HEP).

Participants in the study will undergo skin-prick tests with the mite extracts and the histamine solution. The size of the skin reaction will be measured to assess the potency of the extracts. The study will also monitor for any adverse reactions to ensure safety. The trial is designed to help improve the understanding and standardization of allergy testing for these specific mite allergens.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes reviewing medical history and confirming sensitization to specific allergens through a skin prick test or specific IgE serum test.

2 skin-prick test administration

The skin-prick test involves administering solutions containing allergenic extracts of mites and a histamine dihydrochloride solution. The solutions are applied subcutaneously, which means they are injected just under the skin.

The allergens tested include Dermatophagoides pteronyssinus, Dermatophagoides farinae, Blomia tropicalis, and Lepidoglyphus destructor. The histamine dihydrochloride solution is used as a control to compare the size of the skin reaction.

3 observation and measurement

After the administration of the skin-prick test, the size of the wheal (a raised, red area on the skin) is measured. This helps determine the biological activity of the allergenic extracts.

The primary endpoint is the area of the wheal produced by the allergenic extracts compared to the histamine control.

4 safety monitoring

Throughout the study, safety is monitored by observing any adverse reactions that may occur. This includes any unexpected skin reactions or other symptoms.

5 completion of study

The study is estimated to conclude by November 30, 2024. At the end of the study, the data collected will be analyzed to determine the biological potency of the allergenic extracts.

Who Can Join the Study?

Patients must be between the ages of 18 and 65, including both ages.
Patients must agree to participate by signing a consent form.
Patients should have a previous medical history that confirms they have an allergy.
Patients must show a reaction to certain allergens, which are substances that can cause an allergic reaction. This can be shown by:

A skin prick test, which is a test where a small amount of allergen is placed on the skin to see if there is a reaction. A positive result is when the reaction is at least 3 mm in size compared to a negative control.
A specific IgE serum test, which is a blood test that measures the level of IgE antibodies to the allergen. A result of 3.5 kUA/L or higher is needed.

These tests must have been done within the last 18 months before joining the study.
Women who can become pregnant must have a negative pregnancy test. This applies to women from the start of menstruation until after menopause, unless they have had surgery to prevent pregnancy.

Who Cannot Join the Study?

Individuals with allergies to the substances being tested cannot participate. Allergies are when your body reacts negatively to certain things, like pollen or certain foods.
Participants must be within a specific age range, which is not specified here, but generally means they need to be of a certain age to join.
Both male and female participants are considered, but certain conditions might exclude someone based on gender-specific health issues.
People who are part of a vulnerable population are not included. This means individuals who might need special protection or care, like those with certain disabilities or health conditions.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country
El Hospital Universitario De Gran Canaria Dr. Negrin	Las Palmas De Gran Canaria	Spain
Virgen del Rocío University Hospital	Sevilla	Spain
Cidumjqh Hdsghwfpvxnd Utfkbcwfrsukk Dz Vtqr	Vigo	Spain

Trial status

Country	Status	Recruitment Start
Spain	Not recruiting	01.09.2024

Trial locations

Investigated drugs:

Dermatophagoides pteronyssinus extract is an allergenic extract derived from the house dust mite Dermatophagoides pteronyssinus. It is used in the trial to determine its biological activity in patients who are sensitive to this specific allergen.

Dermatophagoides farinae extract is another allergenic extract obtained from the house dust mite Dermatophagoides farinae. This extract is tested to evaluate its ability to produce a skin reaction in sensitive individuals, similar to a histamine solution.

Blomia tropicalis extract is an allergenic extract from the mite Blomia tropicalis. The trial uses this extract to assess its potency in causing a skin reaction in patients who are allergic to this type of mite.

Lepidoglyphus destructor extract is an allergenic extract from the mite Lepidoglyphus destructor. It is included in the trial to measure its effectiveness in producing a skin response in individuals with allergies to this specific mite.

Investigated diseases:

Hypersensitivity

Allergies – Allergies are hypersensitive responses of the immune system to substances that are generally harmless to most people, known as allergens. Common allergens include pollen, dust mites, mold, pet dander, and certain foods. When exposed to an allergen, the immune system mistakenly identifies it as a threat and releases chemicals like histamine, leading to symptoms such as sneezing, itching, and swelling. Allergies can affect different parts of the body, including the skin, respiratory system, and digestive tract. The severity of allergic reactions can vary from mild irritation to more severe responses. Over time, exposure to allergens can lead to chronic conditions such as asthma or eczema.

Trial ID:

2024-513834-40-01

Protocol code:

DIA-STA04080912-0124

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Allergenic Extracts of Mites and Histamine Dihydrochloride for Allergy Patients

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