Clinical Evaluation of T.R.U.E. Test Allergens in Children an Adolescents

Not Applicable

Completed

Interventions: Diagnostic Test: Panels 1.3, 2.2 and 3.2 experimental allergens

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Positive Response Rates: 7 new and 4 reformulated allergens	Panels 1.3, 2.2 and 3.2 experimental allergens	Subjects will be patched with TRUE Test Panels 1.3, 2,2 and 3.2. Panel 1 allergens nickel sulfate (0.60 mg/cm2), potassium dichromate (0.054 mg/cm2), fragrance mix (0.050 mg/cm2) and ethylenediamine dihydrochloride (0.050 mg/cm2), Panel 2 allergen Methyldibromoglutaronitrile (0.0053 mg/cm2) and Panel 3 allergens Gold sodium thiosulfate (0.075 mg/cm2), Hydrocortisone-17-butyrate (0.020 mg/cm2), Bacitracin (0.60 mg/cm2), Parthenolide (0.0030 mg/cm2), Disperse blue 106 (0.050 mg/cm2 in PVP), 2-Bromo-2-nitropropane-1,3-diol (Bronopol) (0.25 mg/cm2) will be evaluated

Primary Outcome Measures

Name	Time	Method
Number of Participants With Negative, Positive, Irritant or Doubtful Reaction Scores	Investigator Determination of Positive Reaction: 21 days post application	Reactions at patch test sites were evaluated:Negative: No reaction, Irritant: Discrete, patchy, follicular, or homogenous erythema with no infiltration, Doubtful: Faint macular or homogenous erythema with no infiltration, 1+: Faint macular or homogenous erythema with no infiltration, 2+: Erythema, papules, infiltration, discrete vesicles 3+: Coalescing vesicles, bullous reaction

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Late or Persistent Positive Patch Test Reactions	Day 7-21	Late reactions are positive reactions that initially occur at 7-21 days after application of the panels. Persistent reactions are positive reactions that persist from one visit to the next. Numbers reported only include late or persistent positive patch test reactions. Not all positive reactions are late or persistent.

Locations (4): Dermatology Specialists
🇺🇸
Louisville, Kentucky, United States
Rady Children's Hospital
🇺🇸
San Diego, California, United States
Anschutz Health and Wellness Center, University of Colorado
🇺🇸
Aurora, Colorado, United States
Oregon Health & Science University
🇺🇸
Portland, Oregon, United States