Standardization of Latex allergenic extract. Determination of biological activity in HEP units

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-001880-68-DE

Enrollment

Registered

2005-07-21

Start date

2005-09-23

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

The objective of the study is to know the biologic activity of the Latex reference extract (IHRP) in HEP units. The HEP value will be the reference of every other diagnostic or treatment preparations.

Interventions

Product Name: latex allergen extract Product Code: latex Pharmaceutical Form: Cutaneous solution

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: ·Patients should live in an environment where allergy caused by Latex is a relevant problem. ·Patients should not be excluded due to low or high sensitivity to the allergen, when they otherwise fulfill the inclusion criteria. ·A positive case history with inhalant allergy related to exposure to the allergen to be tested. ·A positive prick test (mean wheal diameter ³ 3 mm) when tested with a standardized extract prepared from the allergen source in question and/or a positive test for specific IgE. ·A mean wheal diameter ³ 7 mm2 obtained in a prick test with histamine dihydrochloride 10 mg/ml. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: ·Immunotherapy in the past 2 years with an allergen preparation known to interfere with the allergens to be tested. ·Use of drugs that may interfere with the skin reactions. ·Pregnancy, dermographism, atopic dermatitis (locally at the test site), urticaria.

Design outcomes

Primary

Measure	Time frame
Main Objective: Open, unblinded and non-randomized biological assay. In each patient four ten- fold concentrations of allergen should be tested in duplicate starting with the lowest concentration with histamine as reference solution. Should the patient develop a skin reaction > 2 fold histamine reaction during test procedure a higher concentrated test solution will not be applied;Secondary Objective: No secondary endpoints will be measured;Primary end point(s): Wheal size area (mm2) of the immediate phase reaction	—

Measure

Time frame

Main Objective: Open, unblinded and non-randomized biological assay. In each patient four ten- fold concentrations of allergen should be tested in duplicate starting with the lowest concentration with histamine as reference solution. Should the patient develop a skin reaction > 2 fold histamine reaction during test procedure a higher concentrated test solution will not be applied;Secondary Objective: No secondary endpoints will be measured;Primary end point(s): Wheal size area (mm2) of the immediate phase reaction

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Countries

Germany

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026