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Clinical Evaluation of T.R.U.E. TEST® Fragrance Mix and Thimerosal Allergens:Bioequivalence of PVP Formulations

NCT00612768 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2018-04-09

Study results available
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Summary

Open, prospective, multi-center study to evaluate the bioequivalence of povidone (PVP) formulations of 2 T.R.U.E. TEST allergens: fragrance mix and thimerosal.

Conditions

  • Dermatitis, Contact

Interventions

BIOLOGICAL

TRUE Test allergens Fragrance Mix and Thimerosol

* Thimerosal, 0.008 mg/cm2 in hydroxypropylcellulose * Thimerosal, 0.008 mg/cm2 in polyvinylpyrrolidone * Fragrance mix, 0.43 mg/cm2 in hydroxypropylcellulose with β-cyclodextrin * Fragrance mix, 0.43 mg/cm2 in polyvinylpyrrolidone with β-cyclodextrin Patches are placed at day one and removed 48 hours. The duration of the study lasts 21 days. However, the subject is only exposed the the study allergen for 48 hours.

Sponsors & Collaborators

  • Allerderm

    lead INDUSTRY

Principal Investigators

  • Joseph Fowler, MD · Dermatology Specialists PSC

  • Luz Fonacier, MD · Winthrop University Hospital

  • Donald V. Belsito, MD · American Dermatology Associates

  • Jerri Hoskyn, MD · River City Dermatology

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2008-12-31
Completion
2009-10-31

Countries

  • United States

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 NCT00612768 on ClinicalTrials.gov