Allergic ReactionsNCT07195929
Determination of Blomia Tropicalis Allergen Extract in Prick Test Units
A study testing Allergenic Extract in people with Allergic Reactions and Allergic Skin Reaction, run by Inmunotek S.L. at 1 site in Spain.
Trial summary
The primary objective is to assess the concentration of Blomia tropicalis allergenic extract that induces a wheal of size equivalent to that produced by a 10 mg/mL histamine dihydrochloride solution, in order to be used as in-house reference preparation (IHRP). Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Allergic Reactions, Allergic Skin Reaction
- What is being tested?
- Allergenic Extract
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- Nov 2025to Jan 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Female or male aged 18 to 64 years, both included.
- Subjects who have signed and dated the informed consent form.
- Subjects must reside in a geographical area where allergic problems caused by Blomia tropicalis are relevant.
- Positive medical history of inhalant allergy (rhinitis and/or rhinoconjunctivitis and/or asthma) to Blomia tropicalis
- 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.
- 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.
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- The area of the wheal obtained with negative control should be < 7 mm², which corresponds to a mean wheal diameter < 3 mm.
- 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.
- 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.
Who cannot join
- Subjects outside the age range.
- 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.
- Subjects with significant symptoms of rhinoconjunctivitis and/or bronchial asthma in whom discontinuation of systemic antihistamine treatment is contraindicated.
- Subjects who have previously exhibited a severe adverse reaction during diagnostic skin prick tests.
- Subjects on treatment with ß-blockers.
- Use of drugs that could interfere with skin prick test reactions (e.g., antihistamines) (See Section 5.2).
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- Clinically unstable subjects (acute asthma, febrile, etc.).
- 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).
- Subjects with active herpes simplex viral infection, or herpes varicella zoster in the area where the prick test is performed.
- Subjects with any pathology in which the administration of adrenaline is contraindicated (hyperthyroidism, hypertension, heart disease, etc.).
- States in which the subject is unable to offer cooperation and severe psychiatric disorders.
- Pregnant or potentially pregnant women and breastfeeding women.
- Subjects with known phenol allergy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site
Hospital Universitario de Canarias
San Cristóbal de La Laguna, Santa Cruz De Tenerife, 38320
Hospital Universitario de Canarias, +34 922 678 283
About this study
Official title: Blomia Tropicalis Allergen Extract. Determination of the Vivo Histamine Equivalent Prick Test Units
The primary objective is to assess the concentration of Blomia tropicalis allergenic extract that induces a wheal of size equivalent to that produced by a 10 mg/mL histamine dihydrochloride solution, in order to be used as in-house reference preparation (IHRP).
Read the detailed description
The trial will consist of a single visit, in which the following procedures will be carried out:
- Demographic data (age, race, and gender).
- Clinical history.
- Inclusion/exclusion criteria.
- Physical examination (cardiovascular, pulmonary, neurobiological, gastrointestinal, dermatological, other body systems and height, weight).
- Pregnancy test.
- Performance of prick-tests (3 concentrations of of Blomia tropicalis extract, positive control, and negative control).
- Collection of blood sample (10 mL) from the patient to create a pool of sera for in vitro standardization of the allergen extract.
Each serum sample will be labeled with the subject's number and frozen. These serum samples will remain in the freezer until the study concludes. Once the study is complete, they will be transported to the sponsor's facilities, where all sera will be pooled. This serum pool will be used for additional in vitro tests necessary to standardize and characterize the extract and produce its corresponding In-House Reference Product (IHRP), as indicated by the Spanish Pharmacopeia and the European Pharmacopeia. Additionally, it will be used in the necessary in vitro analyses for the standardization of new batches of the allergenic extract. After the serum pool is formed, the tubes containing the original serum samples are destroyed.
- Assessment of adverse events during the 72 hours following skin testing.
- Conditions
- Allergic Reactions, Allergic Skin Reaction
- Being tested
- Allergenic Extract
- Keywords
- Allergy, In-House Reference Preparation (IHRP), Prick test, Blomia tropicalis
- Medical subject headings
- Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allergenic ExtractOther
Also called Allergenic Blomia tropicalis extract
In each subject, a drop of each of the 3 concentrations of the allergenic extract, in addition to the positive control (histamine) and the negative control, will be applied. The application will be duplicated on the subject's anterior forearm, with a distance of approximately 4 cm between each application to avoid overlapping reactions and false-positives results.
| Study group | Role | What they receive |
|---|---|---|
| Extract B. tropicalis + Positive control + Negative control | Experimental | There is only one treatment arm. In each subject, one drop of each of the three concentrations of both allergenic extracts, along with the positive (Histamine dihydrochloride 10 mg/mL) and negative (saline solution) controls, will be applied. Blomia tropicalis dilutions: 100 µg/mL and 20 µg/mL. Receives: Other: Allergenic Extract |
What is being measured
The primary outcome is the main question the study is designed to answer.
Size of the induced papule on the skin
Size of the induced papule on the skin when applying each of the concentrations of the allergenic extracts and the positive (histamine) and negative controls, using the prick test.
Measured: 15 minutes
Secondary outcomes (1)
Adverse reactions
The secondary outcome is to assess the safety and tolerability of Blomia tropicalis extract. Mild side reactions such as pruritus, erythema, local oedema may occur during the diagnostic skin test by prick test. There is a risk, albeit rare and exceptional, of systemic reactions, sometimes severe (urticaria, asthma, anaphylactic shock) (28) (urticaria, asthma, anaphylactic shock, etc.).
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2025
- Study startNov 2025 (estimated)
- Primary completionJan 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Allergic ReactionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Phase II trial, open-label, prospective, non-randomized, without a control group of subjects.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inmunotek S.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- María Inmaculada Sánchez Machín, Principal investigator, Hospital Universitario de Canarias
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07195929
- Sponsor's protocol ID
- M608-STD-067
- Other IDs
- 2024-515169-33-00
- Status last verified
- Sep 2025
- First submitted
- 19 Sep 2025
- Last updated
- 2 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Skin tests used in type I allergy testing Position paper. Sub-Committee on Skin Tests of the European Academy of Allergology and Clinical Immunology. Allergy. 1989;44(s10):11-59. No abstract available.
PubMed 2683837Casanovas M, Maranon F, Bel I. Comparison of skin-prick test assay and reverse enzyme immunoassay competition (REINA-C) for biological activity of allergens. Clin Exp Allergy. 1994 Feb;24(2):134-9. doi: 10.1111/j.1365-2222.1994.tb00209.x.
PubMed 8187028Pawankar R. Allergic diseases and asthma: a global public health concern and a call to action. World Allergy Organ J. 2014 May 19;7(1):12. doi: 10.1186/1939-4551-7-12. eCollection 2014. No abstract available.
PubMed 24940476