Clinical Evaluation of T.R.U.E. Test Panel 3.2 in Children and Adolescents (PREA II)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 116
- Locations
- 8
- Primary Endpoint
- Number of Participants With Negative, Positive, Irritant or Doubtful Reaction Scores
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 6 Years to 17 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Number of Participants With Negative, Positive, Irritant or Doubtful Reaction Scores
Time Frame: 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 Outcomes
- Number of Participants With Late or Persistent Positive Patch Test Reactions(Day 7-21)