Clinical Evaluation of Metal Panel Allergens: Safety and Efficacy Study

SmartPractice0 个研究点目标入组 300 人开始时间: 2023年2月7日最近更新: 2025年4月10日

适应症

试验速览

暂无简介。

•The study population will consist of two groups of subjects. Group 1 will include the intended population, individuals with suspected allergic contact dermatitis to one or more of the investigational metal allergens. Subjects may have active dermatitis attributable to metal allergy at the time of enrollment or a recent history (within the past 5 years) of dermatitis that is suspected to be due to metal allergy that resolved prior to enrollment due to treatment or elimination of exposure to the suspected metal trigger. Group 2 will include patients without history or symptoms of metal-induced allergic contact dermatitis and without chronic exposure

•Participation in SmartPractice dose response study
•Breastfeeding or pregnant
•Topical treatment with corticosteroids or immunosuppressive agents on or near the test area
•Systemic treatment with corticosteroids or immunosuppressive agents
•Treatment with UV light
•Dermatitis on or near the test area on the back
•Known or suspected infection of the skin, joints or other site(s) associated with metal exposure
•Fibromyalgia, chronic fatigue, depression, cognitive impairment, flu-like symptoms, diarrhea and/or headache without at least one of the symptoms related to metal exposure
•Psoriasis, dermatitis herpetiformis, mycosis fungoides or cutaneous T-cell lymphoma
•Inability to comply with patch test study requirements
•Participation in an investigational clinical trial 3 weeks prior to inclusion in this study.
•An opinion of the Investigator that deems the potential subject is unsuitable

Elicitation of allergic reaction.

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