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Study on Allergy to Lepidoglyphus Destructor: Testing with Lepidoglyphus Destructor Extract, Histamine Hydrochloride, and Sodium Chloride in Affected Patients

Verified siteInvestigationalNo placebo
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What is this trial about?

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

This clinical trial is focused on studying an allergy to Lepidoglyphus destructor, a type of dust mite. The trial aims to determine the allergenic strength of a solution made from Lepidoglyphus destructor extract. This is done by comparing it to a standard solution of histamine hydrochloride, which is commonly used in allergy testing. The study involves using a skin prick test, a method where small amounts of the allergen are placed on the skin to see if a reaction occurs. The trial will use three different solutions: a negative control with sodium chloride, a positive control with histamine hydrochloride, and the test solution with Lepidoglyphus destructor extract.

The purpose of the study is to find out the concentration of the Lepidoglyphus destructor extract that causes a skin reaction similar in size to the reaction caused by the histamine solution. Participants will undergo skin prick testing, where these solutions are applied to the skin to observe any allergic reactions. The study will help in understanding how potent the Lepidoglyphus destructor extract is in causing an allergic reaction compared to the standard histamine solution.

Participants in the study will have a history of inhalant allergies, such as rhinitis or asthma, specifically to Lepidoglyphus destructor. The study will involve a simple procedure where small drops of the solutions are placed on the skin, and the size of any resulting wheal, or raised bump, is measured. This will help in assessing the allergenic potency of the Lepidoglyphus destructor extract in comparison to the known effects of histamine.

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

    Enrollment

    Upon joining the study, eligibility is confirmed based on a history of allergy to Lepidoglyphus destructor and a positive skin test or specific IgE presence.

    Women of childbearing age must present a negative pregnancy test and commit to using effective contraception during the trial and for 72 hours after treatment ends.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to measure the skin's reaction to a 10 mg/mL histamine dihydrochloride solution. The wheal size must be at least 7 mm².

  3. Step 3

    Skin prick test

    The skin prick test involves applying three solutions to the skin: a negative control with sodium chloride, a positive control with histamine hydrochloride, and the test solution with Lepidoglyphus destructor extract.

    All solutions are applied cutaneously, meaning they are placed on the skin's surface.

  4. Step 4

    Observation and measurement

    After the application of the solutions, the skin's reaction is observed. The size of the wheal, or raised area, is measured to determine the allergenic potency of the Lepidoglyphus destructor extract.

  5. Step 5

    Completion

    The trial concludes with the assessment of the concentration of Lepidoglyphus destructor extract that produces a wheal size equivalent to the histamine solution.

Who can join the trial?

7 criteria

  • Have a positive medical history of inhalant allergy, which means having symptoms like sneezing, runny nose, or breathing problems, to **Lepidoglyphus destructor**.
  • Show a positive result on a skin test, where a small amount of the allergen is placed on the skin to see if it causes a reaction, with a wheal (a raised, red, itchy area) that is at least 3 mm in size, or have specific **IgE** (a type of antibody) to the allergen.
  • The average size of the wheal from a test using **10 mg/mL Histamine dihydrochloride** should be at least 7 mm². Histamine dihydrochloride is a substance used to test how the skin reacts.
  • Be between 18 and 64 years old.
  • Be able to understand and agree to participate in the study by signing a consent form.
  • Women who can have children must have a negative urine pregnancy test when joining the trial and must have had a recent menstrual period.
  • Women who can have children must agree to use a highly effective birth control method during the trial and for 72 hours after the treatment ends. These methods include hormonal birth control that stops ovulation, devices placed inside the uterus, condoms, diaphragms with spermicide, surgical sterilization, having a partner who has had a vasectomy, or choosing not to have sex.

Who cannot join the trial?

1 criterion

  • Having an allergy to Lepidoglyphus destructor. An allergy is when your body reacts to something that is usually harmless, causing symptoms like sneezing or itching.
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Investigated drugs

  • Lepidoglyphus destructor extract

    is being tested to determine its allergenic potency. This extract is used to assess how it affects the skin by comparing the size of the reaction it causes to that of a standard histamine solution. The goal is to find out the concentration of this extract that produces a similar skin reaction to a known amount of histamine.

  • Histamine dihydrochloride solution

    is used as a reference in this trial. It is a standard solution that causes a known reaction on the skin, which helps researchers compare the effects of the Lepidoglyphus destructor extract. This comparison helps in understanding the allergenic potency of the extract.

What is already known about the treatment

Lepidoglyphus destructor extract – This medication is administered through a skin prick test, where a small amount of the extract is applied to the skin to assess allergic reactions. It is currently being studied in clinical trials to determine its allergenic potency, specifically for allergies to Lepidoglyphus destructor, a type of dust mite. The main therapeutic indication is to diagnose allergies by comparing the skin's reaction to the extract with that of a standard histamine solution. The mechanism of action involves triggering an immune response in individuals allergic to this specific dust mite, which is then measured by the size of the skin reaction. It falls under the pharmacological classification of diagnostic agents used in allergy testing.

Investigated diseases

Allergy to Lepidoglyphus destructor – This is an allergic reaction to a specific type of dust mite known as Lepidoglyphus destructor. Individuals with this allergy may experience symptoms such as sneezing, runny or stuffy nose, itchy eyes, and skin rashes. The allergy occurs when the immune system overreacts to proteins found in the mite's body or waste. Exposure to these mites can lead to inflammation in the nasal passages or skin. Over time, repeated exposure may worsen symptoms or lead to chronic allergic conditions. Managing the environment to reduce mite exposure is often necessary to alleviate symptoms.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-509541-13-00Protocol codeM603-STD-061Estimated enrolment30 patientsSponsorInmunotek S.L.

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