NCT02028182

Clinical Evaluation of Lyral® Dose Response Study

Clinical Evaluation of Hydroxyisohexyl 3-cyclohexene Carboxaldehyde (Lyral®) Dose Response Study

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Allerderm · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine optimal allergen dose as the lowest concentration eliciting positive reactions in 70-90% of subjects. Frequency of positive, negative, doubtful and irritant reactions, and concordance with a corresponding reference allergens will be captured.

Detailed description

This is a single-center, randomized study to compare the diagnostic performance and safety of ascending doses (0.10 mg/cm², 0.20 mg/cm² and 0.40 mg/cm²) of hydroxyisohexyl 3-cyclohexene carboxaldehyde (Lyral®) in 20 adult subjects with a past positive patch test to Lyral® or Fragrance Mix 2.

Conditions

• Contact Dermatitis

Interventions

Type	Name	Description
BIOLOGICAL	Lyral®	Alergen panel containing ascending doses of Lyral (0.10 mg/cm\^2, 0.20 mg/cm\^2 and 0.40 mg/cm\^2) and negative control

Timeline

• Start date: 2013-02-01
• Primary completion: 2013-06-01
• Completion: 2013-06-01
• First posted: 2014-01-07
• Last updated: 2023-07-28
• Results posted: 2020-08-24

Locations

1 site across 1 country: Denmark