Clinical Evaluation of Lyral® Dose Response Study

NCT02028182 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2023-07-28

Study results available
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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.

Conditions

  • Contact Dermatitis

Interventions

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

Sponsors & Collaborators

  • Allerderm

    lead INDUSTRY

Principal Investigators

  • Evy Paulsen, Md, PhD · Department of Dermatology and Allergy Centre Odense University Hospital

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-02-28
Primary Completion
2013-06-30
Completion
2013-06-30

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02028182 on ClinicalTrials.gov