Clinical trial NCT01797562: Clinical Evaluation of T.R.U.E. Test Allergens in Children an Adolescents
Official title: Clinical Evaluation of T.R.U.E. Test Panel 3.2 in Children and Adolescents (PREA II)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Allergic Contact Dermatitis
Keywords: Contact dermatitis
Eczema
Lead sponsor: Allerderm
Sponsor class: INDUSTRY
First posted: 2013-02-22
Enrollment: 116
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 3 T.R.U.E. Test panels were applied to the paraspinal regional of the back and were to be worn for approximately 48 hours. Post application evaluations were performed at days 3, 4, 7(+1) and 21(+2).
Primary purpose: DIAGNOSTIC

Brief summary: The objective of the study was to evaluate the diagnostic performance and safety of T.R.U.E. Test allergens in pediatric subjects aged 6-17 years old. In total, 11 allergens were evaluated; 7 new allergens on panels 2.2 and 3.2 and 4 previously approved allergens for which changes were made to dose and excipient.

Detailed description: The evaluation of 7 new allergens on panels 2.2 and 3.2, Gold sodium thiosulfate, Hydrocortisone-17-butyrate, Bacitracin, Parthenolide, Methyldibromoglutaronitrile, Disperse blue 106, and Bronopol was the original objective of the study. The protocol was amended to include evaluation of 4 reformulated allergens; neomycin sulfate, potassium dichromate, ethylenediamne dihydrochloride and fragrance mix.

Eligibility 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

Primary outcomes:
measure: Number of Participants With Negative, Positive, Irritant or Doubtful Reaction Scores
timeFrame: Investigator Determination of Positive Reaction: 21 days post application
Secondary outcomes:
measure: Number of Participants With Late or Persistent Positive Patch Test Reactions
timeFrame: Day 7-21
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Rady Children's Hospital
state: California
city: Aurora
country: United States
facility: Anschutz Health and Wellness Center, University of Colorado
state: Colorado
city: Louisville
country: United States
facility: Dermatology Specialists
state: Kentucky
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
Study officials:
affiliation: Anschutz Health and Wellness Center, University of Colorado, Aurora, CO
name: Cory Dunnick, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dermatology Specialists, Louisville, KY
name: Joseph Fowler, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rady Children's Hospital, San Diego
name: Lawrence Eichenfield, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Oregon Health and Science University
name: Patricia Norris, MD
role: PRINCIPAL_INVESTIGATOR
References: