Clinical Evaluation of T.R.U.E. TEST Panel 3.2 in Children and Adolescents (PREAII)

February 26, 2013 updated by: Allerderm
To evaluate the diagnostic performance (primary) and safety (secondary) of seven T.R.U.E. Test Panel 3.2 allergens: Gold sodium thiosulfate, Hydrocortisone-17-butyrate, Bacitracin, Parthenolide, Methyldibromoglutaronitrile, Disperse blue 106, and Bronopol in pediatric subjects 6-18 years of age with suspected contact dermatitis based on symptoms and clinical history.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

The study population will include at least 100 consecutive subjects 6-17 years of age with suspected contact dermatitis based on symptoms and clinical history. Study subjects must be otherwise healthy and fulfill entry criteria.

Visit 1 (Day 0): Informed Consent, Inclusion/Exclusion Criteria Assessment, Medical and Medicine History, Pregnancy Test (for female subjects of child-bearing potential), Panel Placement.Visit 2 (Day 2): Panel Removal, Panel Adhesion and Irritation Assessment, AE and Concomitant Medication Review.Visit 3 (Day 3- approximately 72 hours after placement): Skin Reactions Assessed and Scored. Adverse Event and Concomitant Medication Review.Visit 4 (Day 4 approximately 96 hours after placement): Skin Reactions Assessed and Scored. Adverse Event and Concomitant Medication Review.Visit 5 (Day 7±1): Skin Reaction Assessed and Scored. AE and Concomitant Medication Review. Visit 6 (Day 21±2): Skin Reaction Assessed and Scored. AE and Concomitant Medication Review. Visit performed via phone call, unless investigator determines that subject should be seen in clinic.

Primary Endpoint: Frequency and characterization of positive reactions per allergen. Secondary Endpoint: Prevalence of late or persistent reactions, irritation, adhesion, subject-reported itching or burning, and adverse events.

Study Type

Interventional

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Anschutz Health and Wellness Center, University of Colorado
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Dermatology Specialists

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Symptoms and history potentially consistent with allergic contact dermatitis based on symptoms and clinical history (i.e., subjects are visiting the clinic/physician to diagnose, treat or resolve this condition).
  • Children and adolescents 6 to 18 years of age, and in general good health.
  • Adolescent females 15 years of age or older (or with menarche) must consent to a urine pregnancy test; urine test results must be negative for study inclusion.
  • Informed consent must be signed and understood by subject. If under age, informed consent must be signed and understood by parent or legal guardian, consistent with all institutional, local and national regulations.

Exclusion Criteria:

  • Topical corticosteroid treatment during the last 7 days on or near the test area.
  • Systemic treatment with corticosteroids or other immunosuppressives during the last 7 days.
  • Subjects currently receiving (or received during the previous 3 weeks) other investigational drugs, treatments or devices, or participating in another clinical study.
  • Treatment with ultraviolet (UV) light (including tanning) during the previous 3 weeks.
  • Acute dermatitis outbreak or dermatitis on or near the test area on the back.
  • Subjects unable to comply with activity restrictions (e.g., protecting test panels from excess moisture due to showering or vigorous activity).
  • Subjects unable or unwilling to comply with multiple return visits.
  • Female subjects 15 years of age (or with onset of menarche) and older unable to consent to a urine pregnancy test, or those with a positive pregnancy test.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Patch Test
Biological: Patch Test
Patch Tested with Gold sodium thiosulfate, 0.075 mg/cm2 in hydroxypropylcellulose · Hydrocortisone-17-butyrate, 0.020 mg/cm2 in polyvinylpyrrolidone· Methyldibromoglutaronitrile, 0.0053 mg/cm2 in polyvinylpyrrolidone·Bacitracin, 0.60 mg/cm2 in hydroxypropylcellulose· Parthenolide, 0.0030 mg/cm2 in polyvinylpyrrolidone· Disperse blue 106, 0.050 mg/cm2 in polyvinylpyrrolidone· Bronopol, 0.25 mg/cm2 in polyvinylpyrrolidone
Other Names:
  • T.R.U.E. TEST

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Frequency and characterization of positive reactions per allergen.
Time Frame: 72 hours, 96 hours, 1 week, 21 Days
72 hours, 96 hours, 1 week, 21 Days

Secondary Outcome Measures

Outcome Measure
Time Frame
Prevalence of late or persistent reactions, irritation, adhesion, subject-reported itching or burning, and adverse events.
Time Frame: 72 hours, 96 hours, 1 week, 21 days
72 hours, 96 hours, 1 week, 21 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Allerderm

Investigators

  • Principal Investigator: Cory Dunnick, MD, Anschutz Health and Wellness Center, University of Colorado, Aurora, Colorado

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (ANTICIPATED)

December 1, 2013

Study Completion (ANTICIPATED)

December 1, 2013

Study Registration Dates

First Submitted

March 16, 2011

First Submitted That Met QC Criteria

January 23, 2012

First Posted (ESTIMATE)

January 26, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

February 27, 2013

Last Update Submitted That Met QC Criteria

February 26, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Mekos 107P3.2 401

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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