Skip to content

In vivo biological standardization of Dermatophagoides allergen extracts.

Status
Withdrawn
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-514108-15-00
Acronym
API-EAD-2024-01
Enrollment
96
Registered
2024-09-09
Start date
Unknown
Completion date
Unknown
Last updated
2024-09-09

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

Conditions

Allergies

Brief summary

The area of the wheal (mm2) that occurs at the cutaneous level after the administration of the extracts in the prick test for the calculation of the primary endpoint., Estimation of the dose/response relationship in each patient; regression analysis of area values ​​versus concentration in PNU/ml., Determination of the theoretical concentration of extract that produces a papule equivalent to that produced by a solution of histamine at 10 mg/ml

Detailed description

Evaluation of the sensitivity and specificity of the extract concentration defined in the main objective of the study., Safety assessment through descriptive analysis of adverse reactions that could occur during the course of the study

Interventions

Sponsors

Advanced Outcomes Research S.L., Asac Pharmaceutical Inmunology S.A.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
The area of the wheal (mm2) that occurs at the cutaneous level after the administration of the extracts in the prick test for the calculation of the primary endpoint., Estimation of the dose/response relationship in each patient; regression analysis of area values ​​versus concentration in PNU/ml., Determination of the theoretical concentration of extract that produces a papule equivalent to that produced by a solution of histamine at 10 mg/ml

Secondary

MeasureTime frame
Evaluation of the sensitivity and specificity of the extract concentration defined in the main objective of the study., Safety assessment through descriptive analysis of adverse reactions that could occur during the course of the study

Countries

Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026