Clinical Evaluation of T.R.U.E. TEST Panel 3.2 in Children and Adolescents
Information source: Allerderm
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Contact Dermatitis
Intervention: Patch Test (Biological)
Phase: Phase 3
Status: Withdrawn
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, Colorado
Joseph Fowler, MD, Principal Investigator, Affiliation: Dermatology Specialists, Louisville, KY
Summary
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.
Clinical Details
Official title: Clinical Evaluation of T.R.U.E. TEST Panel 3.2 in Children and Adolescents
Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Primary outcome: Change in 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:
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.
Eligibility
Minimum age: 6 Years.
Maximum age: 18 Years.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Anschutz Health and Wellness Center, University of Colorado, Aurora, Colorado 80045, United States
Dermatology Specialists, Louisville, Kentucky 40202, United States
Additional Information
Starting date: December 2012
Last updated: February 26, 2013
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