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Dust mite allergy test gets a tune-up in new study

NCT ID NCT07195929

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Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
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Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

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Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study aims to find the best concentration of Blomia tropicalis (a type of dust mite) extract for allergy skin testing. About 30 adults with known dust mite allergies will receive small pricks with different extract strengths to see which causes a reaction similar to a standard histamine control. The goal is to improve the accuracy of allergy diagnosis for this common allergen.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Nov 2025

An estimate. Start dates often move.

Expected to finish

Jan 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 64 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Female or male aged 18 to 64 years, both included. 2. Subjects who have signed and dated the informed consent form. 3. Subjects must reside in a geographical area where allergic problems caused by Blomia tropicalis are relevant. 4. Positive medical history of inhalant allergy (rhinitis and/or rhinoconjunctivitis and/or asthma) to Blomia tropicalis 5. A positive prick-test (mean wheal diameter ≥ 3 mm) with an extract of the same allergen and/or presence of specific IgE against complete extract or any molecular component to the allergenic source. 6. The area of the wheal obtained with 10 mg/mL histamine dihydrochloride should be ≥ 7 mm², which corresponds to a mean wheal diameter ≥ 3 mm. 7. The area of the wheal obtained with negative control should be \< 7 mm², which corresponds to a mean wheal diameter \< 3 mm. 8. Women of childbearing age (i.e following menarche and until postmenopause, defined as no menses for 12 months without an alternative medical cause, or non-subject to permanent sterilization methods, such as hysterectomy, bilateral salpingectomy and bilateral oophorectomy) must present a negative urine pregnancy test at the time of enrollment in the trial, as well as a confirmed menstrual period. 9. 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. Exclusion Criteria: 1. Subjects outside the age range. 2. Subjects who have previously received immunotherapy within the last 5 years for the treatment of asthma or allergic rhinoconjunctivitis induced by allergens that may interfere with Blomia tropicalis extract. 3. Subjects with significant symptoms of rhinoconjunctivitis and/or bronchial asthma in whom discontinuation of systemic antihistamine treatment is contraindicated. 4. Subjects who have previously exhibited a severe adverse reaction during diagnostic skin prick tests. 5. Subjects on treatment with ß-blockers. 6. Use of drugs that could interfere with skin prick test reactions (e.g., antihistamines) (See Section 5.2). 7. Clinically unstable subjects (acute asthma, febrile, etc.). 8. Subjects 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). 9. Subjects with active herpes simplex viral infection, or herpes varicella zoster in the area where the prick test is performed. 10. Subjects with any pathology in which the administration of adrenaline is contraindicated (hyperthyroidism, hypertension, heart disease, etc.). 11. States in which the subject is unable to offer cooperation and severe psychiatric disorders. 12. Pregnant or potentially pregnant women and breastfeeding women. 13. Subjects with known phenol allergy.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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  3. A doctor treating you

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Contacts and locations

Locations

  • Hospital Universitario de Canarias

    San Cristóbal de La Laguna, Santa Cruz De Tenerife, 38320, Spain

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