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Standardization of Dermatophagoides pteronyssinus and Dermatophagoides farinae extracts and histamine dihydrochloride in skin testing for patients with dust mite allergy

Registered drugNo placebo
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What is this trial about?

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

Participants who have an IgE-mediated respiratory allergic disease caused by dust‑mite allergens will be asked to undergo a skin test that measures how their immune system reacts to tiny amounts of the allergens. The two dust‑mite allergens being studied are Dermatophagoides pteronyssinus and Dermatophagoides farinae, which are common triggers of sneezing, wheezing and itchy eyes.

The aim of the study is to find the exact amount of each allergen extract that creates a skin swelling (called a wheal) the same size as the reaction produced by a standard solution of histamine dihydrochloride. To do this, participants will receive a series of very small injections just under the skin (intraepidermal) of the allergen extracts at different strengths, as well as a control injection of the histamine solution.

During the visit, the skin reactions will be measured and recorded, allowing researchers to compare the size of the wheals from the allergen extracts with the histamine control. The information gathered will help create a reliable reference for future allergy testing and treatment planning.

The research process

The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Enrollment confirmation

    patient receives study information and signs the consent form confirming participation in the trial.

  2. Step 2

    Baseline assessment

    Medical history related to ig e‑mediated respiratory allergic disease is recorded.

    Allergy to dermatophagoides pteronyssinus (dpt) and dermatophagoides farinae (df) is confirmed.

  3. Step 3

    Preparation for skin test

    The forearm skin area is cleaned with an alcohol swab.

    Each test solution is labeled with its concentration.

  4. Step 4

    Application of test solutions

    The following solutions are injected intraepidermally (into the skin) one at a time:

    dpt 0.01 mg/ml, dpt 0.1 mg/ml, dpt 1 mg/ml, dpt 10 mg/ml,

    df 0.01 mg/ml, df 0.1 mg/ml, df 1 mg/ml, df 10 mg/ml,

    And a positive control solution of histamine dihydrochloride 10 mg/ml.

  5. Step 5

    Observation period

    After each injection, the site is observed for about fifteen minutes.

    The size of the raised skin reaction (wheal) is noted.

  6. Step 6

    Measurement and recording

    The diameter of each wheal is measured with a ruler.

    All measurements are entered into the study record.

  7. Step 7

    Determination of biological activity

    The wheal size produced by each allergen concentration is compared with the wheal size from the histamine control.

    The concentration that creates a wheal of equivalent size to the histamine control is identified as the standardized activity level.

  8. Step 8

    Final visit and result summary

    The patient attends a final visit where the recorded data are reviewed.

    No additional medication is administered after the skin test.

Who can join the trial?

6 criteria

  • Have a past medical record showing a breathing‑related allergy (including rhinitis – a runny or blocked nose, rhinoconjunctivitis – itchy eyes with a runny nose, or asthma – difficulty breathing) that is triggered by the allergen being tested.
  • Provide written permission (called informed consent) that is signed and dated by you or your legal representative.
  • Be between 18 and 60 years old.
  • Show a positive result on a skin prick test, meaning a small drop of the allergen placed on the skin creates a raised bump (papule) at least 3 mm across.
  • Have a positive blood test for the specific allergen, called a serum IgE test, with a result of class 3 or higher (indicating a strong level of allergy‑related antibodies).
  • Live in a region where allergies to this specific allergen are common enough to be a relevant health problem.

Who cannot join the trial?

10 criteria

  • Anyone who has received allergy shots (called immunotherapy) in the past five years with extracts that can mix with the test allergen, because they might cause a reaction that interferes with the study.
  • Anyone who is taking medicines that can change the skin’s reaction, such as antihistamines, during the time of the study.
  • Anyone who is using any of the following drugs: tricyclic antidepressants, tetracyclic antidepressants, MAO inhibitors (a type of antidepressant), beta‑blockers, long‑term oral steroids, or oral or injectable steroids taken repeatedly at doses higher than 10 mg per day of prednisone (or an equivalent).
  • Women who are pregnant or are feeding a baby (breastfeeding).
  • People who have skin conditions such as dermographism (skin that reacts to light pressure), active atopic dermatitis (eczema), or urticaria (hives) on the area where the test will be done.
  • Anyone with serious problems of the immune system, including autoimmune diseases (where the body attacks itself) or immunodeficiencies (where the immune system is weak).
  • People who have severe or poorly controlled asthma.
  • Anyone with serious, uncontrolled illnesses that could make participation unsafe.
  • People who have conditions that would make the use of adrenaline (a medicine used for severe allergic reactions) risky, such as coronary heart disease or very high blood pressure (severe hypertension).
  • Anyone who has received treatment that blocks IgE antibodies, such as the drug Omalizumab (anti‑IgE treatment).
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Investigated drugs

Dermatophagoides pteronyssinus extract solution
This is a liquid containing proteins from the dust‑mite species *Dermatophagoides pteronyssinus*. It is applied to the skin using a tiny needle (intraepidermal test) to see if a person’s immune system reacts. In the trial, the reaction size is measured to determine how strong the allergen extract is, helping to standardize its biological activity for future allergy testing and treatment. Dermatophagoides farinae extract solution
Similar to the first product, this liquid contains proteins from the dust‑mite species *Dermatophagoides farinae*. It is also used in a skin prick test, where a small amount is placed on the skin and punctured. The size of the skin reaction shows how sensitive the patient is to this specific mite allergen and assists in setting a standard level of activity for the extract. Histamine dihydrochloride solution
Histamine is a substance that naturally causes a skin reaction, such as redness and swelling. In this study, a known concentration of histamine dihydrochloride is applied to the skin as a reference point. The allergic reactions to the mite extracts are compared to the reaction produced by histamine, allowing researchers to gauge the strength of the allergen extracts.

What is already known about the treatment

  • Solución para prueba con extractos alergénicos DPT 0.1 por punción cutánea

    This is a sterile liquid solution applied by a small skin prick (intra‑epidermal) during allergy testing. It contains the dust‑mite protein Dermatophagoides pteronyssinus at a concentration of 0.1 mg/ml and is used to identify sensitization to this common allergen. The extract works by binding to IgE antibodies on skin mast cells, which can cause a small raised bump if the person is allergic. It is classified as an allergen extract diagnostic agent and is widely accepted in clinical practice for skin‑test standardization.

  • Solución para prueba con extractos alergénicos DF 0.1 por punción cutánea

    This sterile solution is also applied by intra‑epidermal skin prick to test for allergy to Dermatophagoides farinae, another dust‑mite species, at 0.1 mg/ml. It helps doctors determine whether a patient’s immune system reacts to this specific mite protein. The allergen proteins trigger IgE‑mediated activation of mast cells, producing a visible wheal when sensitization is present. It is an allergen extract diagnostic product that is routinely used in allergy clinics.

  • Solución para prueba con extractos alergénicos DPT 10 por punción cutánea

    This liquid allergen extract is administered by intra‑epidermal skin prick at a high concentration of 10 mg/ml. It is employed to assess strong reactions or to calibrate the test response for Dermatophagoides pteronyssinus sensitivity. The high dose provides more allergen protein to bind IgE on mast cells, leading to a larger wheal if the patient is allergic. It is a diagnostic allergen extract, approved for use in skin‑test standardization.

  • HISTAMINE DIHYDROCHLORIDE

    Histamine dihydrochloride is a clear solution injected into the skin (intra‑epidermal) as a positive control during allergy skin testing. It is a well‑known reference substance that produces a predictable wheal and flare reaction at 10 mg/ml. Histamine works by directly activating histamine receptors on blood vessels and nerves, causing swelling and redness. It is classified as a vasoactive amine and is universally used as a standard comparator in skin‑prick tests.

  • Solución para prueba con extractos alergénicos DF 10 por punción cutánea

    This sterile liquid is applied by intra‑epidermal skin prick at 10 mg/ml to test for reactions to Dermatophagoides farinae. It is used to detect strong sensitization or to set a reference point for other concentrations. The mite proteins bind to IgE on skin mast cells, causing a wheal when the immune system is reactive. It is an allergen extract diagnostic agent commonly used in allergy testing.

  • Solución para prueba con extractos alergénicos DPT 0.01 por punción cutánea

    This low‑dose (0.01 mg/ml) sterile solution is delivered by intra‑epidermal skin prick to evaluate mild sensitivity to Dermatophagoides pteronyssinus. It helps clinicians identify patients who react only to very small amounts of the allergen. The extract’s proteins interact with IgE on mast cells, producing a small wheal if the patient is sensitized. It is an allergen extract used for diagnostic skin testing.

Investigated diseases

  • Allergic rhinitis due to house dust mite

    It is an IgE‑mediated inflammation of the nasal passages that occurs after inhaling proteins from dust mites. The first signs are sneezing, itchy nose, and a clear runny discharge. With repeated exposure the nasal lining becomes swollen, leading to persistent congestion and post‑nasal drip. Over time the condition may cause a constant feeling of blockage and irritation. Symptoms often fluctuate with indoor dust levels and seasonal changes.

  • Allergic asthma due to house dust mite

    This is an IgE‑driven lung condition where dust‑mite allergens trigger airway inflammation. Early episodes appear as occasional wheezing or shortness of breath after exposure. Continued exposure makes coughing, chest tightness, and breathlessness more frequent. The airways become increasingly reactive, so even small amounts of allergen can provoke symptoms. The pattern typically worsens when indoor dust concentrations rise.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2026-525628-13-00Protocol codePRO-PT-2025-01Estimated enrolment30 patientsSponsorProbelte Pharma S.L.

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