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

Allerderm Laboratories

Status and phase

Completed

Phase 4

Conditions

Dermatitis, Contact

Treatments

Biological: T.R.U.E. Test

Study type

Interventional

Funder types

Industry

Identifiers

NCT00795951

MEKOS 07 29P1/2/3/401

Details and patient eligibility

About

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.

Full 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 reactions will be evaluated at days 2, 3 (+1), 7 and 21 following panel application

Enrollment

102 patients

Sex

All

Ages

6 to 18 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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.