Metal Panel Patch Test Study

JRCT ID: jRCT2031220654

Registered date:22/02/2023

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Skin rash, Eczema
• Date of first enrollment: 07/02/2023
• Target sample size: 300
• Countries of recruitment: USA,Japan,Germany,Japan,Italy,Japan,Netherland,Japan
• Study type: Interventional

Intervention(s)

Diagnostic skin test for contact allergy
Apply patchtest panel 1 time

Outcome(s)

• Primary Outcome: Elicitation of allergic reaction.
• Secondary Outcome: Allergen safety

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both
• Include criteria: 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

Exclude criteria

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

Related Information

• Primary Sponsor: Yoshizumi Yuriko
• Secondary ID(s): NCT04500834