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An exploratory phase IV, randomised, double-blind, placebo controlled crossover study to assess and compare the effects of 5 mg vs. 20 mg Desloratadine on the development of experimentally induced urticaria lesions - AUDACU

An exploratory phase IV, randomised, double-blind, placebo controlled crossover study to assess and compare the effects of 5 mg vs. 20 mg Desloratadine on the development of experimentally induced urticaria lesions - AUDACU

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2005-006133-32-DE
Enrollment
30
Registered
2006-06-28
Start date
2006-09-20
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

Acquired cold urticaria (ACU) is a frequent form of physical urticaria that is characterized by the development of wheal and flare type skin reactions after cold exposure. MedDRA version: 8.1 Level: LLT Classification code 10046741 Term: Urticaria cold

Interventions

Trade Name: Aerius Product Name: Desloratadine Product Code: SCH34117 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: DESLORATADINE CAS Number: 100643718 Concentration unit: mg milligram(

Sponsors

Allergie-Centrum-Charité
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: ACU patients aged 18-70 years, signed written consent, no systemic corticosteroid or other immunosuppressive therapy, no permanent severe diseases 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) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: The presence of permanent severe diseases, especially those affecting the immune system, except ACU, History of adverse reactions to Desloratadine, Intake of corticoids with the last 14 days, History or presence of alcohol abuse or drug addiction, Pregnancy or breast-feeding

Design outcomes

Primary

MeasureTime frame
Main Objective: Reduction in the development of urticaria lesions (wheal and flare) induced by TEMPTest challenge as assessed by digital time lapse photography and thermography;Secondary Objective: 1. Decrease in critical temperature thresholds as assessed by standardized TEMPTest challenges 2. Increase in critical stimulation time thresholds (TEMPTest) 3. Patient evaluation of urticaria symptoms after provocation ;Primary end point(s): Efficacy of treatment—

Countries

Germany

Outcome results

None listed

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