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CompletedNCT01964768Updated Oct 17, 2013

Sensitivity and Specificity of 3 Solutions of Allergen Extract for Diagnosis by Skin Prick Testing

A Phase 3 interventional study of Skin prick-test in Allergy, sponsored by Stallergenes Greer. Completed. Open to participants aged 5 Years to 60 Years. Per ClinicalTrials.gov, last updated 2013-10-17.

Sponsored by Stallergenes Greer · Phase 3, Interventional, and Diagnostic

Phase
Phase 3
Study type
Interventional
Enrollment
324
Allocation
Not applicable
Ages
5 Years to 60 Years
Sex
All
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Study summary

A Phase III study to determine the sensitivity and specificity of three solutions of different allergen extracts for diagnosis by skin prick-test:

  • 5 Grasses pollen,
  • Birch pollen,
  • Dermatophagoides pteronyssinus mite
02

Conditions studied

  • Allergy

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03

In context

Hypersensitivity

1,916 studies on the registry are indexed under Hypersensitivity; 265 are open to participants now.

This study's enrollment of 324 is above the median of 57 across 1,384 interventional studies indexed under Hypersensitivity.

Browse Hypersensitivity studies →

Lead sponsor

Stallergenes Greer is the lead sponsor of 25 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
5 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Written informed consent to participate in the study
  • Male or female subjects aged 5-60 years inclusive
  • Female of childbearing potential must be on a reliable method of contraception and have a negative urine pregnancy test
  • Presence of a clinical history of allergy: seasonal or perennial rhinitis, conjunctivitis and/or asthma during grass or birch pollen seasons (at least two pollen seasons) and/or due to mite exposure (at least two years)
  • Subjects affiliated to a social security system

Exclusion criteria

Exclusion Criteria:

  • Pregnant or breastfeeding women
  • Dermographism
  • Absence of cutaneous reactivity
  • Presence of cutaneous lesions on the forearms either preventing the performance of the test or potentially interfering with the interpretation of the test
  • Subjects presenting unstable asthma or poor general health condition
  • Subjects with past or current specific immunotherapy treatment for any of the 3 tested allergens (Grass, Birch pollens, D. pteronyssinus and/or D. farinae mites) in the previous 5 years
  • Any oral antihistaminic treatment in the previous 3 days or 10 days in case of loratadine or desloratadine
  • Subjects on anti-IgE treatment
  • Subjects treated with beta-blockers and/or anti-depressives.
  • Subjects currently participating in another clinical trial or still in exclusion period for a previous clinical trial
  • Investigators, co-investigators, as well as their children or spouses and all the study collaborators
  • Subjects under protection of the courts, legal guardianship or legal trusteeship
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Study design

Phase
Phase 3
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
Double (Participant, Investigator)
Enrollment
324 participants (actual)

Interventions

  • OtherSkin prick-test
06

What researchers measure

Primary outcomes

  1. Skin wheal measure for each tested solution. For each allergen tested, 2 variables, positive SPT and negative SPT were defined. A SPT reaction was considered positive when the mean wheal diameter was >3 mm. A SPT reaction ≤3 mm was considered negative.

    Time frame: For each subject, the study consisted in one visit of about 60 minutes including skin prick-test and collection of blood sample for IgE determination.

Secondary outcomes

  1. One of the secondary measurement was the wheal diameter for each allergen.

    Time frame: SPT measurements were performed after the study visit, an expected average of 1 week.

Other outcomes

  1. The secondary measurement was also the specific IgE level for each allergen.

    Time frame: Specific IgE results were known after the study visit, an expected average of 3 days.

07

Study locations

No study locations are listed for this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 17, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01964768
Lead sponsor
Stallergenes Greer
Responsible party
Sponsor
First posted
Oct 17, 2013
Start date
Dec 2010
Primary completion
Jun 2011
Completion
Feb 2012
Last update
Oct 17, 2013

Study contacts

Frédéric de Blay, Pr
principal investigator · Hôpitaux Universitaires de Strasbourg, Nouvel Hôpital Civil, Strasbourg, France

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2013. You cannot join it, but the record below documents what was studied.

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