Clinical Evaluation of T.R.U.E. Test Allergens in Children an Adolescents
Information source: Allerderm
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Allergic Contact Dermatitis
Intervention: T.R.U.E. Test Panel 3.2 (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Allerderm Official(s) and/or principal investigator(s):
Cory Dunnick, MD, Principal Investigator, Affiliation: Anschutz Health and Wellness Center, University of Colorado, Aurora, CO
Joseph Fowler, MD, Principal Investigator, Affiliation: Dermatology Specialists, Louisville, KY
Lawrence Eichenfield, MD, Principal Investigator, Affiliation: Rady Children's Hospital, San Diego
Patricia Norris, MD, Principal Investigator, Affiliation: Oregon Health and Science University
Overall contact:
Kim Sullivan, Phone: 602-225-0595
Summary
To evaluate the performance and safety of seven T. R.U. E. Test Panel allergens in subjects
6-17 years of age with suspected contact dermatitis.
Clinical Details
Official title: Clinical Evaluation of T.R.U.E. Test Panel 3.2 in Children and Adolescents (PREA II)
Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Primary outcome: Frequency and characterization of positive reactions per allergen.
Secondary outcome: Prevalence of late or persistent reactions, irritation, adhesion, subject-reported itching or burning, and adverse events.
Detailed description:
To evaluate the diagnostic performance (primary) and safety (secondary) of seven T. R.U. E.
Test Panel allergens; Gold sodium thiosulfate, Hydrocortisone-17-butyrate, Bacitracin,
Parthenolide, Methyldibromoglutaronitrile, Disperse blue 106, and Bronopol in pediatric
subjects 6-17 years of age with suspected contact dermatitis based on symptoms and clinical
history.
Eligibility
Minimum age: 6 Years.
Maximum age: 17 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Symptoms and history potentially consistent with allergic contact dermatitis
- Children and adolescents 6-17 years of age, 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 underage, 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
Locations and Contacts
Kim Sullivan, Phone: 602-225-0595
Rady Children's Hospital, San Diego, California 92123, United States; Recruiting
Ann Funk, RN, Phone: 858-576-1700, Ext: 4295
Lawrence Eichenfield, MD, Principal Investigator
Anschutz Health and Wellness Center, University of Colorado, Aurora, Colorado 80045, United States; Recruiting
Teresa Derian, RN, Phone: 303-724-9155
Cory Dunnick, MD, Principal Investigator
Dermatology Specialists, Louisville, Kentucky 40202, United States; Recruiting
Maureen Beyel, RN, Phone: 502-582-7546
Joseph Fowler, MD, Principal Investigator
Oregon Health & Science University, Portland, Oregon 97239, United States; Recruiting
Kristin Morton, Phone: 503-494-6442
Patricia Norris, MD, Principal Investigator
Additional Information
Starting date: December 2012
Last updated: September 22, 2014
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