MedPath

Metal Panel Patch Test Study

Phase 3
Conditions
Skin rash, Eczema
D000066491
Registration Number
JPRN-jRCT2031220654
Lead Sponsor
Yoshizumi Yuriko
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
All
Target Recruitment
300
Inclusion 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

Exclusion 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

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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