Trials / Completed
CompletedNCT01797562
Clinical Evaluation of T.R.U.E. Test Allergens in Children an Adolescents
Clinical Evaluation of T.R.U.E. Test Panel 3.2 in Children and Adolescents (PREA II)
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 116 (actual)
- Sponsor
- Allerderm · Industry
- Sex
- All
- Age
- 6 Years – 17 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | Panels 1.3, 2.2 and 3.2 experimental allergens | Three allergen panels will be applied to the upper backs of study subjects and will be worn for 48 hours. Allergen test sites will be evaluated at 3, 4, 7(±1) and 21(±2) days post application. |
Timeline
- Start date
- 2012-12-10
- Primary completion
- 2015-09-08
- Completion
- 2015-09-08
- First posted
- 2013-02-22
- Last updated
- 2020-08-21
- Results posted
- 2020-08-12
Locations
4 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01797562. Inclusion in this directory is not an endorsement.