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Allergen extract of Lepidoglyphus destructor. Study of the sensitivity and specificity of the diagnostic preparation in prick tests
EU CTIS ID: 2025-523426-40-00
What this study is testing
The main objective is to determine the sensitivity and specificity of the different concentrations of the allergenic extract L. destructor, as well as other parameters (efficiency, positive and negative predictive value, and probability ratio of a positive and negative test) that will be used for the prick test.The results will provide the data necessary to choose the optimal concentration of each allergen extract to be used for each preparation.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Participants who have signed and dated the informed consent form.
- Specific IgE with a value > 0.35 kU/L to whole extract of L. destructor (Inclusion criteria for CH+ participants (true positives for L. destructor)).
- Negative prick test (mean wheal diameter < 3 mm) to a standardized extract of L. destructor (Inclusion criteria for CH- participants (true negatives for L. destructor)).
- Specific IgE with a value < 0.35 kU/L to an extract of L. destructor (Inclusion criteria for CH- participants (true negatives for L. destructor)).
- Positive clinical history of inhalant allergy (rhinitis and/or rhinoconjunctivitis and/or asthma) to other perennial allergens or pollens, but not to L. destructor (Inclusion criteria for CH- participants (true negatives for L. destructor)).
- Participants aged between 12 and 70 years, both sexes included
You likely can't join if
- 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 a known allergy to phenol.
- Pregnant or breastfeeding women.
- Participants who have received previous immunotherapy in the last 5 years or are being treated with an allergen extract of L. destructor (Exclusion criteria for HC+ participants (true positives for L. destructor)).
- 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.
See the full eligibility criteria
Who can join
- Participants who have signed and dated the informed consent form.
- Specific IgE with a value > 0.35 kU/L to whole extract of L. destructor (Inclusion criteria for CH+ participants (true positives for L. destructor)).
- Negative prick test (mean wheal diameter < 3 mm) to a standardized extract of L. destructor (Inclusion criteria for CH- participants (true negatives for L. destructor)).
- Specific IgE with a value < 0.35 kU/L to an extract of L. destructor (Inclusion criteria for CH- participants (true negatives for L. destructor)).
- Positive clinical history of inhalant allergy (rhinitis and/or rhinoconjunctivitis and/or asthma) to other perennial allergens or pollens, but not to L. destructor (Inclusion criteria for CH- participants (true negatives for L. destructor)).
- 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.
- Positive clinical history of inhalant allergy (rhinitis and/or rhinoconjunctivitis and/or asthma) to L. destructor (Inclusion criteria for CH+ participants (true positives for L. destructor).
- Positive prick test (mean wheal diameter ≥ 3 mm) to a standardized extract of L. destructor (Inclusion criteria for CH+ participants (true positives for L. destructor)).
What rules you out
- 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 a known allergy to phenol.
- Pregnant or breastfeeding women.
- Participants who have received previous immunotherapy in the last 5 years or are being treated with an allergen extract of L. destructor (Exclusion criteria for HC+ participants (true positives for L. destructor)).
- 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.).
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.