Status:
WITHDRAWN
Clinical Evaluation of T.R.U.E. TEST Panel 3.2 in Children and Adolescents
Lead Sponsor:
Allerderm
Conditions:
Contact Dermatitis
Eligibility:
All Genders
6-18 years
Phase:
PHASE3
Brief Summary
To evaluate the diagnostic performance (primary) and safety (secondary) of seven T.R.U.E. Test Panel 3.2 allergens: Gold sodium thiosulfate, Hydrocortisone-17-butyrate, Bacitracin, Parthenolide, Methy...
Detailed Description
The study population will include at least 100 consecutive subjects 6-17 years of age with suspected contact dermatitis based on symptoms and clinical history. Study subjects must be otherwise healthy...
Eligibility Criteria
Inclusion
- Symptoms and history potentially consistent with allergic contact dermatitis based on symptoms and clinical history (i.e., subjects are visiting the clinic/physician to diagnose, treat or resolve this condition).
- Children and adolescents 6 to 18 years of age, and 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 under age, 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 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01518348
Start Date
December 1 2012
End Date
December 1 2013
Last Update
February 27 2013
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Anschutz Health and Wellness Center, University of Colorado
Aurora, Colorado, United States, 80045
2
Dermatology Specialists
Louisville, Kentucky, United States, 40202