Diagnostic accuracy of Dermatophagoides pteronyssinus and Dermatophagoides farinae allergen extracts for skin prick testing in patients with house dust mite allergy
- Trial ID
- 2025-522469-31-00
- Protocol
- M601-SSP-080
- Sponsor
- Inmunotek S.L.
Trial statistics
Diseases & Conditions
Objectives
The primary objective is to determine the diagnostic performance of different concentrations of Dermatophagoides pteronyssinus and Dermatophagoides farinae skin-prick test extracts. This includes sensitivity, specificity, efficiency, positive and negative predictive values, and positive and negative likelihood ratios, which are clinically relevant for assessing the accuracy of the prick test in allergic diagnosis. The secondary objectives are to evaluate the safety and tolerability of each allergenic extract and to determine the allergenic profile of each participant using the ALEX technique.
Participants
The sponsor did not provide the total number of participants. The trial population included patients of both sexes, aged 12 to 70 years, with allergic disease related to allergy to Dermatophagoides pteronyssinus and allergy to Dermatophagoides farinae. Participants were selected on the basis of informed consent and predefined clinical and test-based eligibility criteria. The population included individuals with a positive clinical history of inhalant allergy, positive prick test and specific IgE to the relevant allergens, as well as individuals with a positive clinical history to other perennial allergens or pollens but negative prick test and specific IgE to these two allergens. Relevant lifestyle considerations were not provided. Key criteria included valid positive and negative control prick tests and, for women of childbearing age, a negative urine pregnancy test and use of highly effective contraception during the trial and for 72 hours after treatment.
Plans and Procedures
This is a prospective, non-randomized, controlled clinical trial designed to evaluate the sensitivity and specificity of skin-prick test preparations containing Dermatophagoides pteronyssinus and Dermatophagoides farinae extracts at different concentrations. The study includes screening and enrollment after verification of eligibility criteria, including clinical history, prior prick test results, specific IgE assessment, and control responses. The trial procedures consist of administration of the test extracts together with positive and negative controls, followed by assessment of wheal area and recording of safety outcomes, including local and systemic adverse reactions and any treatment required for adverse reactions. The overall trial period is estimated from 2026-07-23 to 2026-11-30. Participant involvement is limited to the study visits required for screening, test administration, and end-of-study assessment. Early termination may occur in the event of failure to meet inclusion criteria, withdrawal of consent, protocol non-compliance, pregnancy, or any adverse event or clinical finding considered incompatible with continued participation.
Treatment
The investigational treatments consisted of Dermatophagoides pteronyssinus extract 100 HEP/mL solution for skin-prick test and Dermatophagoides farinae extract 100 HEP/mL solution for skin-prick test. Both were administered by cutaneous use as a solution for skin-prick test, at a dose of 2 drops per application. The study evaluated different concentrations of each allergenic extract for diagnostic performance in prick testing. The protocol also included auxiliary comparator preparations: a skin-prick test positive control containing histamine dihydrochloride, and a skin-prick test negative control containing sodium chloride. These controls were also administered by cutaneous use as solutions for skin-prick test, at a dose of 2 drops per application. The study assessed sensitivity, specificity, efficiency, positive and negative predictive value, and likelihood ratios for positive and negative test results. Compliance monitoring was not described in the source data.
Efficacy
Skin prick test efficacy will be assessed by measuring the area in mm² of wheals induced by different concentrations of the Dermatophagoides pteronyssinus allergen extract and the Dermatophagoides farinae allergen extract. The wheal areas induced by the positive control and negative control will also be measured. These measurements will be used to determine sensitivity, specificity, efficiency, positive and negative predictive value, and the probability ratio of a positive and negative test.
Inclusion and Exclusion Criteria
Inclusion Criteria
- Participants who have signed and dated the informed consent form.
- Participants aged between 12 and 70 years, both sexes included.
- Positive prick test with the positive control (histamine dihydrochloride at 10 mg/mL). The mean wheal diameter induced by this control must be ≥ 3 mm.
- Negative prick test with the negative control. The mean wheal diameter induced by this control must be < 3 mm.
- Women of childbearing age (from menarche to postmenopause, defined as the absence of menstruation for 12 months without an alternative medical cause, or not undergoing permanent sterilization methods, such as hysterectomy, bilateral salpingectomy, and bilateral oophorectomy) must present a negative urine pregnancy test and confirmation of their last menstrual period at the time of enrollment in the trial.
- Women of childbearing age must commit to using a highly effective and adequate contraception method during the trial and up to 72 hours after the end of treatment with the investigational medicinal product. Such methods include combined (estrogen and progestogen containing) hormonal; contraception associated with inhibition of ovulation (oral, intravaginal or transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable or implantable), intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion, vasectomized partner or sexual abstinence.
- (CH+) Positive clinical history of inhalant allergy (rhinitis and/or rhinoconjunctivitis and/or asthma) to D. pteronyssinus and D. farinae.
- (CH+) Positive prick test (mean wheal diameter ≥ 3 mm) to a standardized extract of D. pteronyssinus and a standardized extract of D. farinae.
- (CH+) Specific IgE with a value > 0.35 kU/L to whole extract of D. pteronyssinus and whole extract of D. farinae.
- (CH-) Positive clinical history of inhalant allergy (rhinitis and/or rhinoconjunctivitis and/or asthma) to other perennial allergens or pollens, but not to D. pteronyssinus and D. farinae.
- (CH-) Negative prick test (mean wheal diameter < 3 mm) to a standardized extract of D. pteronyssinus and a standardized extract of D. farinae.
- (CH-) Specific IgE with a value < 0.35 kU/L to an extract of D. pteronyssinus and an extract of D. farinae.
Exclusion Criteria
- Participants with active urticaria lesions, severe active dermographism, severe atopic dermatitis, sunburn, eczema, psoriasis lesions in the area where the prick test is performed (risk of false positives).
- Participants with significant symptoms of rhinoconjunctivitis and/or bronchial asthma in whom discontinuation of systemic antihistamine treatment is contraindicated.
- Participants who have previously exhibited a severe adverse reaction during diagnostic skin prick testing.
- Participants with active viral infection by herpes simplex or herpes zoster in the area where the prick test is performed.
- Participants who are clinically unstable at the time of inclusion in the trial (acute asthma, fever, etc.).
- Participants with any severe psychiatric disorder.
- Participants on treatment with beta-blockers.
- Use of drugs that may interfere with the skin response (e.g., antihistamines) (see Section 8.6.1).
- Participants with any condition in which the administration of adrenaline is contraindicated (hyperthyroidism, hypertension, heart disease, etc.).
- Participants with a known allergy to phenol.
- Pregnant or breastfeeding women.
- (CH+) Participants who have received previous immunotherapy in the last 5 years or are being treated with an allergen extract of D. pteronyssinus and/or D. farinae.
Trial Status by Country
| Country | Status | Start of Recruitment | Planned Patients |
|---|---|---|---|
 Spain | Not Yet Recruiting | 23 Jul 2026 | 70 |
Sites & Investigators
Research sites
Investigators
Investigational Products
Details about the medicinal products being studied in this clinical trial.
| Product Name | Role in Trial | Formulation | Administration | Max Daily Dose | Treatment Duration | EU MP Number |
|---|---|---|---|---|---|---|
Dermatophagoides farinae extract 100 HEP/mL solution for skin-prick test | Test | SOLUTION FOR SKIN PRICK TEST | CUTANEOUS USE | 2 | 1 | PRD13481457 |
Skin Prick Test Negative control | Other | SOLUTION FOR SKIN-PRICK TEST | CUTANEOUS USE | 2 | 1 | PRD11276451 |
Skin Prick Test Positive control | Other | SOLUTION FOR SKIN-PRICK TEST | CUTANEOUS USE | 2 | 1 | PRD11269985 |
Dermatophagoides pteronyssinus extract 100 HEP/mL solution for skin-prick test | Test | SOLUTION FOR SKIN-PRICK TEST | CUTANEOUS USE | 2 | 1 | PRD13480071 |