Skip to content

Phleum pratense and Dactylis glomerata allergen extracts. Determination of the in vivo histamine equivalent prick test units.

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-514215-98-00
Acronym
G110-STD-071
Enrollment
30
Registered
2024-11-06
Start date
2024-11-26
Completion date
2025-02-07
Last updated
2024-11-06

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

Conditions

Allergy to Phleum pratense and Dactylis glomerata.

Brief summary

The primary efficacy endpoint involves measuring the area (mm2) of the induced wheal on the skin upon applying each of the 3 concentrations of each allergenic extract (Phleum pratense and Dactylis glomerata), as well as those induced by positive (histamine) and negative controls, through the prick test.

Detailed description

Overall rate, seriousness, and ratio of any adverse event (AE) by administration and by subject., Assessment of administration site reactions, systemic reactions and any medication administered for the treatment of adverse reaction (AR).

Interventions

DRUGPrick test of enriched Phleum pratense pollen extract
DRUGPrick test of enriched Dactylis glomerata pollen extract

Sponsors

Inmunotek S.L.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
The primary efficacy endpoint involves measuring the area (mm2) of the induced wheal on the skin upon applying each of the 3 concentrations of each allergenic extract (Phleum pratense and Dactylis glomerata), as well as those induced by positive (histamine) and negative controls, through the prick test.

Secondary

MeasureTime frame
Overall rate, seriousness, and ratio of any adverse event (AE) by administration and by subject., Assessment of administration site reactions, systemic reactions and any medication administered for the treatment of adverse reaction (AR).

Countries

Spain

Outcome results

None listed

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