Clinical Evaluation of T.R.U.E. TEST® Neomycin Sulfate and Potassium Dichromate Allergens: Bioequivalence of Vehicle Formulations

SmartPractice0 个研究点目标入组 40 人开始时间: 2010年9月23日最近更新: 2021年8月2日

适应症

试验速览

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•·Current or previous symptoms and/or history consistent with allergic contact dermatitis, and positive patch test (within the past 10 years) to the current T.R.U.E. TEST formulation of neomycin sulfate, AND/OR potassium dichromate.
•·All subjects must be adults (18 years of age or older) and otherwise in good health.
•·Female subjects of child-bearing potential must consent to a urine pregnancy test; results must be negative for study inclusion. Menopausal females (amenorrhic for >1 year) may be excluded from a pregnancy test.
•·Informed consent must be signed and understood by each subject, and consistent with all institutional, local and national regulations.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•·Subjects unable to meet inclusion requirements.
•·Women who are breastfeeding or pregnant.
•·Topical treatment during the last 7 days with corticosteroids or other immunosuppressive agents on or near the test area.
•·Systemic treatment during the last 7 days with corticosteroids (equivalent to > 10 mg prednisone) or other immunosuppressive agents.
•·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 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).
•·Subject participation in clinical trials of investigational drugs, treatments, or devices, other than T.R.U.E. TEST, during this study or 3 weeks prior to inclusion in this study.

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