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Skin Prick Test Diagnostic Accuracy Study in Patients with Dermatophagoides pteronyssinus and Dermatophagoides farinae Allergy Using Dermatophagoides pteronyssinus Extract and Dermatophagoides farinae Extract

InvestigationalNo 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 studying allergy to Dermatophagoides pteronyssinus and Dermatophagoides farinae, which are common house dust mites. The test products used in the study are allergen extracts from these mites, given as a skin prick test, along with a negative control made of sodium chloride and a positive control made of histamine dihydrochloride. The purpose of the study is to find out how well different amounts of these mite extracts can detect allergy and how accurate the test is.

During the study, small drops of the test solutions are placed on the skin, and the skin is lightly pricked. This is done with the different mite extracts and with the control solutions. The skin is then checked for a local reaction, such as a small raised area called a wheal, which means a swollen bump on the skin. The study also looks at safety, including any skin reactions or other unwanted effects after the test.

The study is short and is expected to take place over a few months. It focuses on comparing the reactions caused by the different allergen extracts so that the best test strength can be identified for diagnosing these mite allergies.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Study day 1: skin-prick test

    On the day you join the study, you receive a skin-prick test. this is a test in which small drops are placed on the skin and the skin is lightly pricked so the substance can enter the surface of the skin.

    The test uses 2 drops of each product listed below, all given by cutaneous use (on the skin): dermatophagoides farinae extract 100 hep/ml solution for skin-prick test, dermatophagoides pteronyssinus extract 100 hep/ml solution for skin-prick test, skin prick test negative control containing sodium chloride, and skin prick test positive control containing histamine dihydrochloride.

    The negative control is used to show the skin reaction when no allergy is expected. the positive control is used to show that the skin can react as expected. the test extracts are used to check reaction to d. pteronyssinus and d. farinae, which are types of house dust mites.

    The size of the raised skin area, called a wheal, is measured after the test. this measurement is used to assess the reaction to each extract and to the two control solutions.

  2. Step 2

    Safety assessment during and after testing

    During the study visit, your skin is checked for any reaction at the test site. this includes looking for local skin reactions and any general body reaction.

    Any unwanted medical event that happens during or after the test is recorded. if any reaction needs treatment, any medicine given for that reaction is also recorded.

    The study also includes allergen profiling using the alex technique. this is a laboratory method used to look at allergy-related patterns in the blood or other sample, as specified by the study.

  3. Step 3

    Study period

    The study is planned to run from 2026-07-23 to 2026-11-30.

    No repeated dosing schedule, daily medicine use, or long-term treatment course is described in the source data. the only stated administration is the single skin-prick test visit with 2 drops of each listed solution.

Who can join the trial?

14 criteria

  • Be between 12 and 70 years old.
  • Be male or female.
  • Have signed and dated the informed consent form, which means the person agrees to join the study after being informed about it.
  • Have a positive prick test with the positive control called histamine dihydrochloride at 10 mg/mL. A prick test is a small skin test, and the skin bump, called a wheal, must measure 3 mm or more.
  • Have a negative prick test with the negative control. This means the skin bump must measure less than 3 mm.
  • For women who can become pregnant, have a negative urine pregnancy test at the time of joining the study.
  • For women who can become pregnant, be able to confirm the date of the last menstrual period, meaning the last time they had a menstrual period, at the time of joining the study.
  • For women who can become pregnant, agree to use a highly effective birth control method during the study and for 72 hours after treatment ends. Examples include certain hormonal birth control methods, an intrauterine device (IUD), an intrauterine system (IUS) that releases hormone, tubal occlusion (blocked fallopian tubes), a partner who has had a vasectomy, or sexual abstinence (not having sex).
  • Have a positive medical history of inhaled allergy, such as rhinitis (nose allergy), rhinoconjunctivitis (nose and eye allergy), or asthma, to other year-round allergens or pollens, but not to Dermatophagoides pteronyssinus or Dermatophagoides farinae.
  • Have a negative prick test to a standardized extract of Dermatophagoides pteronyssinus and a standardized extract of Dermatophagoides farinae, with a mean wheal diameter of less than 3 mm.
  • Have a specific IgE blood test result of less than 0.35 kU/L to an extract of Dermatophagoides pteronyssinus and an extract of Dermatophagoides farinae. IgE is a type of antibody, which is a protein made by the immune system.
  • Have a positive medical history of inhaled allergy, such as rhinitis, rhinoconjunctivitis, or asthma, to Dermatophagoides pteronyssinus and Dermatophagoides farinae.
  • Have a positive prick test to a standardized extract of Dermatophagoides pteronyssinus and a standardized extract of Dermatophagoides farinae, with a mean wheal diameter of 3 mm or more.
  • Have a specific IgE blood test result of more than 0.35 kU/L to the whole extract of Dermatophagoides pteronyssinus and the whole extract of Dermatophagoides farinae.

Who cannot join the trial?

12 criteria

  • Active skin problems in the area where the prick test will be done, such as hives (raised itchy skin spots), severe dermographism (skin that becomes raised and red after scratching), severe atopic dermatitis (a long-lasting itchy skin inflammation), sunburn, eczema, or psoriasis (a skin condition with thick, scaly patches), because these can cause false test results.
  • A known allergy to phenol (a substance used in some medical products).
  • Being pregnant or breastfeeding.
  • Having received immunotherapy in the last 5 years, or currently being treated with an allergen extract of Dermatophagoides pteronyssinus or Dermatophagoides farinae (treatment made from allergy-causing substances).
  • Having strong symptoms of rhinoconjunctivitis (nose and eye allergy symptoms) and/or bronchial asthma (breathing problems from inflamed airways) when stopping systemic antihistamines (allergy medicines that work throughout the body) is not safe.
  • Having had a severe bad reaction during a previous diagnostic skin prick test.
  • An active viral infection with herpes simplex or herpes zoster in the area where the prick test would be done.
  • Being clinically unstable at the time of joining the study, such as having an acute asthma attack or fever.
  • Having any severe psychiatric disorder (a serious mental health condition).
  • Being treated with beta-blockers (medicines often used for heart or blood pressure problems).
  • Using medicines that can change the skin test response, such as antihistamines (allergy medicines).
  • Having any condition in which adrenaline cannot be used safely, such as hyperthyroidism (an overactive thyroid), hypertension (high blood pressure), or heart disease.
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Investigated drugs

  • Dermatophagoides farinae extract

    is an allergen test solution used in a skin prick test. It is made from house dust mite material and is placed on the skin to see whether it causes an allergic reaction, such as redness or a raised bump. In this trial, it helps doctors check how well this test solution identifies people who are allergic to this mite.

  • Dermatophagoides pteronyssinus extract

    is another allergen test solution used in a skin prick test. It comes from a different house dust mite and is applied to the skin to see if the body reacts to it. This helps researchers measure how accurate the test is at detecting allergy to this specific mite.

  • Histamine

    is used as a positive control in the skin prick test. This means it is expected to cause a small skin reaction in most people, showing that the test is working properly and that the skin can respond as expected.

  • Sodium chloride

    is used as a negative control in the skin prick test. It should not cause an allergic skin reaction. It helps confirm that any reaction seen with the allergen extracts is due to the allergen itself and not to the test procedure.

What is already known about the treatment

  • Dermatophagoides farinae extract

    This medication is given as a skin-prick test solution, applied as one or two drops on the skin, usually on the forearm or back, and then the skin is lightly pricked to let a small amount enter the top layer of the skin. It is used in allergy testing, not as a treatment, to see whether a person reacts to house dust mite allergy from Dermatophagoides farinae. In medical literature, it is a well-known diagnostic allergen extract used in skin testing, and its role is to help confirm or rule out this type of allergy. It belongs to the pharmacological group of allergy test preparations.

  • Dermatophagoides pteronyssinus extract

    This medication is provided as a skin-prick test solution and is applied to the skin as drops before a gentle prick is made through the drop. It is used for allergy diagnosis, mainly to check for sensitivity to house dust mite allergy caused by Dermatophagoides pteronyssinus. In medicine and medical literature, it is a standard diagnostic allergen extract, widely used to study allergic reactions rather than to treat them. It is classified as an allergy test preparation.

  • Sodium chloride

    This medication is used as a negative control in a skin-prick test and is applied as drops on the skin in the same way as the test allergen. It does not normally cause an allergic reaction, so it helps show whether any skin response is due to the allergen itself and not to the test procedure. In medical practice, sodium chloride is a very common and well-established substance, and in this setting it is used only for diagnostic comparison. It is a simple salt solution used as a control preparation in allergy testing.

  • Histamine dihydrochloride

    This medication is used as a positive control in a skin-prick test and is applied as drops on the skin before a gentle prick. It is used to make sure the skin can react normally, because histamine usually causes a small itchy, red bump in most people. In medical literature, histamine dihydrochloride is a well-known substance used in allergy testing, not as a long-term treatment in this context. It belongs to the group of control preparations for allergy tests and works by activating histamine receptors in the skin, which increases blood flow and causes swelling and redness.

Investigated diseases

Allergy to Dermatophagoides pteronyssinus - An allergic disease caused by sensitivity to a house dust mite called Dermatophagoides pteronyssinus. It usually develops as the immune system reacts to the mite, leading to symptoms such as sneezing, nasal itching, runny nose, or itchy eyes when exposure occurs. Symptoms may appear only during contact with the allergen or may become more noticeable with repeated exposure. The condition can persist over time if exposure continues. Allergy to Dermatophagoides farinae - An allergic disease caused by sensitivity to a house dust mite called Dermatophagoides farinae. It develops when the immune system overreacts to this mite, often causing sneezing, nasal congestion, runny nose, or itchy eyes after exposure. The symptoms may come and go with contact, and repeated exposure can make them more frequent or noticeable. The condition may continue as long as exposure to the allergen remains.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-522469-31-00Protocol codeM601-SSP-080Estimated enrolment70 patientsSponsorInmunotek S.L.

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