Clinical Evaluation of T.R.U.E. TEST Panel 3.2 in Children and Adolescents

Withdrawn before enrolling · Phase 3

Conditions studied: Contact Dermatitis

In brief

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, Methyldibromoglutaronitrile, Disperse blue 106, and Bronopol in pediatric subjects 6-18 years of age with suspected contact dermatitis based on symptoms and clinical history.

Key facts

Study ID

NCT01518348

Run by

Allerderm

People needed

0

Starts

2012-12-01

Expected to finish

2013-12-01

Last updated by the study team

2013-02-27

Who can join

Age: 6 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Anschutz Health and Wellness Center, University of Colorado — Aurora, Colorado, United States
• Dermatology Specialists — Louisville, Kentucky, United States

Full record on ClinicalTrials.gov

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