Status:
COMPLETED
Clinical Evaluation of T.R.U.E. TEST in Children and Adolescents
Lead Sponsor:
Allerderm
Conditions:
Dermatitis, Contact
Eligibility:
All Genders
6-18 years
Phase:
PHASE4
Brief Summary
Open, prospective, single-site, non-randomized study of the efficacy and safety of T.R.U.E. TEST allergens in children and adolescents ages 6-18.
Detailed Description
Three T.R.U.E. TEST panels (1.1, 2.1 and 3.1) containing 28 allergens and a negative control will be applied to the skin on the subject's back and worn for approximately 48 hours. Patch test site skin...
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 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 immunosuppressive 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 :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2009
Estimated Enrollment :
102 Patients enrolled
Trial Details
Trial ID
NCT00795951
Start Date
November 1 2008
End Date
November 1 2009
Last Update
August 6 2020
Active Locations (1)
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1
Rady Children's Hospital
San Diego, California, United States, 92123