An interventional study of Allergenic Extract in Allergic Reactions and Allergic Skin Reaction, sponsored by Inmunotek S.L.. Not yet recruiting at 1 site in Spain. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2025-10-02.
Sponsored by Inmunotek S.L. · Not applicable, Interventional, and Other
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).
The trial will consist of a single visit, in which the following procedures will be carried out:
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.
1,055 studies on the registry are indexed under Hypersensitivity; 149 are open to participants now.
This study's planned enrollment of 30 is below the median of 73 across 691 interventional studies indexed under Hypersensitivity.
Browse Hypersensitivity studies →Inmunotek S.L. is the lead sponsor of 26 studies on the registry; 13 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Other: Allergenic 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.
Also known as: Allergenic Blomia tropicalis extract
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.
Time frame: 15 minutes
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.).
Time frame: 30 minutes
Start is estimated for Nov 2025; primary completion for Jan 2026, 2 months later.
Of 24 industry-sponsored interventional studies with no phase under Hypersensitivity, half reached primary completion within 2 months of starting (the median), counting those still running; a quarter within 1 and three quarters within 11. This study's planned 2 months is close to that.
Counting every sponsor, half of 174 studies reached it within 20 months; a quarter within 5 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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