Allergy Testing of Soldiers Prepared for International Mission

NCT05807958 | Completed

• 1 other identifier: 22467
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this prospective mono centric study is to identify relevant commercially available allergen extracts for allergy testing in soldiers prepared for international mission. Participants will receive a skin prick test with the skin prick automated test device including 22 allergens and 2 controls on both forearms.

Conditions

Adult Military Personnel

Outcome Measures

Primary Outcomes (1)

• Allergens with positive skin reaction

  Positive skin reactions of top ranked allergens required to identify 95% of sensitised individuals

  baseline

Secondary Outcomes (2)

• Self-reported allergic diseases

  baseline

• Work Performance & Activity Impairment

  baseline

Study Arms (1)

Skin Prick Automated Test

EXPERIMENTAL

Device: Skin Prick Automated Test

Interventions

Skin Prick Automated Test DEVICE

A skin prick automated test will be performed in each participant.

Skin Prick Automated Test

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult military personnel (18-65y) will be included. Soldiers with and without previous exposure to allergens in the regions of interest will be included. Soldiers who are performing desk tasks and not selected for international missions will serve as controls.

You may not qualify if:

• Skin pathology like chronic or exuberant urticaria, dermographism, chronic dermatitis that needs daily treatment
• Use of antihistaminic medication \< 7 days before the start of the study
• Use of tricyclic antidepressants (antihistamine activity) \< 7 days before the start of the study
• Use of topical corticoids on the forearm \< 7 days before the start of the study
• Use of Omalizumab \< 6 months before the start of the study
• Pregnancy: there is a remote possibility of inducing a systemic allergic reaction that could induce uterine contractions or necessitate the use of epinephrine (thought to cause constriction of the umbilical artery).

Sponsors & Collaborators

• Queen Astrid Military Hospital: lead

Study Sites (1)

Military Hospital Queen Astrid

Brussels, 1120, Belgium

Location

Related Publications (2)

• Gorris S, Uyttebroek S, Backaert W, Jorissen M, Schrijvers R, Thompson MJ, Loeckx D, Seys SF, Van Gerven L, Hellings PW. Reduced intra-subject variability of an automated skin prick test device compared to a manual test. Allergy. 2023 May;78(5):1366-1368. doi: 10.1111/all.15619. Epub 2022 Dec 26. No abstract available.

  PMID: 36495473 BACKGROUND

• Gorris S, Baron I, De Brouwer J, Vanden Daele A, Verstraelen J, Loeckx D, Bousquet J, Van Gerven L, Seys SF. Sensitisation patterns and burden of uncontrolled respiratory allergy symptoms in military personnel. BMJ Mil Health. 2025 Jun 25:military-2025-003006. doi: 10.1136/military-2025-003006. Online ahead of print.

  PMID: 40562451 DERIVED

Study Officials

• Ilan Baron, MD

  Military Hospital Queen Astrid

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical doctor

Study Record Dates

• First Submitted: March 14, 2023
• First Posted: April 11, 2023
• Study Start: March 14, 2023
• Primary Completion: March 8, 2024
• Study Completion: February 7, 2025
• Last Updated: February 28, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)