clinical evaluation of t.r.u.e. test® : safety and efficacy

Conditions: Contact Dermatitis

Summary: we propose an open, prospective, multi-center phase iii study to evaluate the diagnostic performance and safety of seven new t.r.u.e. test allergens: gold sodium thiosulfate, hydrocortisone-17-butyrate, bacitracin, parthenolide, methyldibromoglutaronitrile, disperse blue 106, and bronopol.allergen performance and safety will be evaluated in adult patients with suspected contact dermatitis, and in adult patients with a known or suspected sensitization to at least one of the seven allergens.

primary endpoint: the performance (efficacy) of each allergen will be evaluated in adult patients with suspected contact dermatitis, and in adult patients with a known or suspected sensitization to at least one of the seven allergens. performance will be based on: * calculated concordance/discordance between t.r.u.e. test panel 3.2 allergens and their corresponding petrolatum or aqueous-based allergens. * calculated sensitivity and specificity for t.r.u.e. test panel 3.2 allergens. secondary endpoint: to evaluate the safety of seven t.r.u.e. test panels 3.2 allergens (gold sodium thiosulfate, hydrocortisone-17-butyrate, methyldibromoglutaronitrile, bacitracin, parthenolide, disperse blue 106 and bronopol) in adult subjects with suspected contact dermatitis ("consecutives"), and/or in adult subjects with a clinical history of contact dermatitis and a current or previous positive patch test to one (or more) of these 7 allergens ("sensitives"). evaluations will be based on: * the frequency and characterization of late and/or persistent reactions, tape-induced irritation at the test site, incomplete panel adhesion, and subject-reported sensations of itching or burning during the test period. * the frequency of adverse events and serious adverse events.

Eligibility criteria:
inclusion criteria: * consecutive subjects must report symptoms and/or history consistent with allergic contact dermatitis to at least one of the allergens tested in the study (i.e., subjects are visiting the clinic/physician to diagnose, treat or resolve this condition). * sensitive subjects must have a positive patch test to one of the following allergens within the past 10 years. * gold sodium thiosulfate * methyldibromoglutaronitrile (alone or with phenoxyethanol) * bacitracin * bronopol * disperse blue 106 (alone or with disperse blue 124) * parthenolide (or compositae mix) * hydrocortisone-17-butyrate * all subjects must be adults over 18 years of age, and otherwise in good health. * premenopausal female subjects with childbearing potential must consent to a urine pregnancy test; urine test results must be negative for study inclusion. * informed consent must be signed and understood by each subject, and consistent with all institutional, local and national regulations. exclusion criteria: * subjects unable to meet inclusion requirements. * women who are breastfeeding or pregnant. * topical corticosteroid treatment during the last 7 days before visit 1 on or near the test area. * systemic treatment with corticosteroids or other immunosuppressants during the last 7 days.before visit 1. * subjects currently receiving (or received in the 21 days before visit 1) other investigational drugs, treatments or devices, or participating in another clinical study. * treatment with ultraviolet (uv) light (including tanning) during the 21 days before visit * acute dermatitis outbreak or dermatitis on or near the test area on the back. * subjects unable to comply with patch test study requirements including multiple return visits and activity restrictions (e.g., protecting test panels from excess moisture due to showering or vigorous activity).

Keywords: dermatitis, contact