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Clinical Evaluation of T.R.U.E. TEST® : Safety and Efficacy

NCT00640614 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 235

Last updated 2020-05-05

Study results available
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Summary

We propose an open, prospective, multi-center Phase III study to evaluate the diagnostic performance and safety of seven new T.R.U.E. Test allergens: Gold sodium thiosulfate, Hydrocortisone-17-butyrate, Bacitracin, Parthenolide, Methyldibromoglutaronitrile, Disperse blue 106, and Bronopol.Allergen performance and safety will be evaluated in adult patients with suspected contact dermatitis, and in adult patients with a known or suspected sensitization to at least one of the seven allergens.

Conditions

  • Contact Dermatitis

Interventions

BIOLOGICAL

T.R.U.E. TEST® Skin Patch Test: Dose Response Allergens

Polyvinylpyrrolidone (PVP; excipient 1) Hydrocortisone-17-butyrate, 0.020 mg/cm2 in PVP Hydroxypropylcellulose (HPC; excipient 2) MDBGN, 0.0055 mg/cm2 in PVP Bacitracin, 0.60 mg/cm2 in HPC Gold sodium thiosulfate, 0.075 mg/cm2 in HPC Parthenolide, 0.0030 mg/cm2 in PVP Disperse Blue 106, 0.050 mg/cm2 in PVP Bronopol, 0.25 mg/cm2 in PVP Test patches, with allergens, are placed at day one and removed 48 hours later. The duration of the study lasts 21 days. However, the subject is only exposed to the study allergens for 48 hours.

Sponsors & Collaborators

  • Allerderm

    lead INDUSTRY

Principal Investigators

  • Evy Paulsen, M.D., Ph.D · Odense University Hospital

  • Joseph Fowler, MD · Dermatology Specialists PSC

  • Luz Fonacier, MD · Winthrop University

  • Donald V Belsito, MD · American Dermatology Associates

  • Jerri Hoskyn, MD · Rivery City Dermatology

  • Sandy Skotnicki-Grant, MD · Bay Dermatology Centre

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-04-30
Primary Completion
2009-08-31
Completion
2009-10-31

Countries

  • United States
  • 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 NCT00640614 on ClinicalTrials.gov