Evaluation of Allergenic Potency of Lepidoglyphus Destructor Extract in Patients with Allergy Using Histamine Equivalent Prick Testing Units
- Trial ID
- 2023-509541-13-00
- Protocol
- M603-STD-061
- Sponsor
- Inmunotek S.L.
Trial statistics
Diseases & Conditions
Objectives
The primary objective of this study is to assess the concentration of **Lepidoglyphus destructor extract** that induces a wheal of size equivalent to that produced by a 10 mg/mL **histamine dihydrochloride** solution. This evaluation is clinically relevant as it determines the in vivo allergenic potency of the extract in histamine equivalent prick testing units (HEP), which is crucial for diagnosing and managing **allergy to Lepidoglyphus destructor**. No secondary objectives are specified for this study.
Participants
The clinical trial involves participants with a **medical condition** of allergy to Lepidoglyphus destructor. The study population includes both male and female subjects, aged between 18 and 64 years, who have a positive medical history of inhalant allergy, such as rhinitis, rhinoconjunctivitis, or asthma, specifically to Lepidoglyphus destructor. Participants must have a positive prick-test with a mean wheal diameter of at least 3 mm or the presence of specific IgE to the allergen. The trial does not include a vulnerable population. Women of childbearing age are required to present a negative urine pregnancy test at enrollment and commit to using a highly effective contraception method during the trial and up to 72 hours after the treatment. The sponsor has not provided information regarding the total number of participants in the trial. The selection criteria ensure that participants can provide informed consent and meet specific health and lifestyle requirements relevant to the study's objectives.
Plans and Procedures
The clinical trial is designed to evaluate the **allergenic potency** of Lepidoglyphus destructor extract in individuals with a known allergy to this allergen. This is a Phase IV, randomized, double-blind, controlled trial. The trial aims to determine the concentration of the extract that induces a wheal size equivalent to that produced by a 10 mg/mL histamine dihydrochloride solution. The trial is expected to commence on June 10, 2024, and conclude by December 10, 2024, with an estimated duration of six months.
Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to confirm eligibility based on specific criteria, such as a positive medical history of inhalant allergy to Lepidoglyphus destructor and a positive skin prick test. The inclusion visit will also involve a negative urine pregnancy test for women of childbearing age. Following the screening, participants will attend follow-up visits where the investigational product, a **solution for skin-prick test**, will be administered cutaneously. The primary endpoint is to assess the concentration of the extract that produces a wheal of a specific size, while secondary endpoints are not specified.
The expected length of participant involvement is approximately six months, with conditions for early termination including withdrawal of consent, adverse reactions, or non-compliance with the study protocol. The end-of-study visit will involve a final assessment to ensure participant safety and collect data on the primary endpoint. Throughout the trial, participants will be monitored for any adverse effects, and the trial will adhere to ethical standards and regulatory requirements.
Treatment
The clinical trial involves the use of three distinct **solutions for skin-prick tests**. The first is the **Skin Prick Test Negative Control**, which contains **sodium chloride** as the active substance. This solution is manufactured by INMUNOTEK S.L. and is used as a negative control in the skin prick test. The pharmaceutical form is a solution specifically designed for cutaneous use. The dosage is administered in drops, with a maximum daily dose of 2 drops and a total dose not exceeding 2 nanoliters. The treatment period is limited to one day.
The second solution is the **Skin Prick Test Positive Control**, which contains **histamine hydrochloride**. Also produced by INMUNOTEK S.L., this solution serves as a positive control in the skin prick test. It is similarly formulated as a solution for cutaneous application. The dosage is administered in drops, with a maximum daily dose of 2 drops and a total dose not exceeding 6 nanoliters. The treatment period is restricted to one day.
The third solution is the **Prick Test of Lepidoglyphus Destructor Extract**, which contains the active substance **Lepidoglyphus destructor extract**. This solution is used to assess the allergenic potency of the extract in comparison to the positive control. Manufactured by INMUNOTEK S.L., it is also a solution for cutaneous use. The dosage is administered in drops, with a maximum daily dose of 2 drops and a total dose not exceeding 6 nanoliters. The treatment period is limited to one day.
All solutions are administered via cutaneous application, and participant compliance is monitored to ensure adherence to the dosing schedule. The trial aims to determine the concentration of Lepidoglyphus destructor extract that induces a wheal size equivalent to that produced by a 10 mg/mL histamine dihydrochloride solution.
Efficacy
The efficacy of the clinical trial will be assessed by evaluating the concentration of **Lepidoglyphus destructor extract** that induces a wheal of size equivalent to that produced by a 10 mg/mL histamine dihydrochloride solution. This primary endpoint will be measured using a skin-prick test, which is a standard method for assessing allergic reactions. The trial aims to determine the in vivo allergenic potency of the extract in histamine equivalent prick testing units (HEP).
Inclusion and Exclusion Criteria
Inclusion Criteria
- Positive medical history of inhalant allergy (rhinitis and/or rhinoconjunctivitis and/or asthma) to Lepidoglyphus destructor.
- A positive prick-test (mean wheal diameter ≥ 3 mm) with an extract of the same allergen and/or presence of specific IgE to the allergen.
- The mean area of the wheal obtained with 10 mg/mL Histamine dihydrochloride should be ≥ 7 mm².
- Age between 18 and 64 years.
- Must be able to provide informed consent.
- 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, intrauterine hormone-releasing system, male condom, diaphragm used with spermicide, bilateral tubal occlusion, vasectomized partner or sexual abstinence.
Exclusion Criteria
- 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 Lepidoglyphus destructor extracts.
- 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.
- 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.
- 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 Status by Country
| Country | Status | Start of Recruitment | Planned Patients |
|---|---|---|---|
 Spain | Not Recruiting | 10 Jun 2024 | 30 |
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 |
|---|---|---|---|---|---|---|
Prick test of Lepidoglyphus destructor extract | Test | SOLUTION FOR SKIN-PRICK TEST | CUTANEOUS USE | 2 | 1 | PRD11188019 |
Skin Prick Test Positive control | Other | SOLUTION FOR SKIN-PRICK TEST | CUTANEOUS USE | 2 | 1 | PRD11269985 |
Skin Prick Test Negative control | Other | SOLUTION FOR SKIN-PRICK TEST | CUTANEOUS USE | 2 | 1 | PRD11276451 |