Status:
COMPLETED
Clinical Evaluation of T.R.U.E. Test Allergens in Children an Adolescents
Lead Sponsor:
Allerderm
Conditions:
Allergic Contact Dermatitis
Eligibility:
All Genders
6-17 years
Phase:
NA
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 alle...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 10 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 8 2015
Estimated Enrollment :
116 Patients enrolled
Trial Details
Trial ID
NCT01797562
Start Date
December 10 2012
End Date
September 8 2015
Last Update
August 21 2020
Active Locations (4)
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1
Rady Children's Hospital
San Diego, California, United States, 92123
2
Anschutz Health and Wellness Center, University of Colorado
Aurora, Colorado, United States, 80045
3
Dermatology Specialists
Louisville, Kentucky, United States, 40202
4
Oregon Health & Science University
Portland, Oregon, United States, 97239