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Exploratory performance comparison trial of titanium allergy diagnostic agent

Exploratory performance comparison trial of titanium allergy diagnostic agent - Exploratory performance comparison trial of titanium allergy diagnostic agent

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000021240
Enrollment
50
Registered
2016-03-01
Start date
2016-03-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Titanium allergy

Interventions

Perform patch test to healthy person with titanium sulfate solution and titanimu chloride solution and oxidized titanium, it is judged according to the criteria of International Contact Dermatitis Res

Sponsors

Hiroshima University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Subjects who agree to participate for a week-long study. 2.Subjects who agree for a written informed consent for participating in this study. 3. Subjects without any symptoms of allergy (allergic dermatitis, palmoplantar pustulosis and lichen planus) and titanium allergy over the past decade.

Exclusion criteria

Exclusion criteria: 1. Subjects who cannot interrupt the anti-allergic drugs from 3 days before patch test to date ended. 2. Subjects who have used corticosteroid medicine internally and/or externally within 1 month prior to the study. 3. Pregnant women and women of child bearing potential. 4. Subjects who cannot give informed consent.

Design outcomes

Primary

MeasureTime frame
Positive rate, negative rate, safety (rate of irritation response) and specificity to 0.1%, 0.5% titanium sulfate solution, 0.1% titanium chloride solution and oxidized titanium on the 7th day.

Secondary

MeasureTime frame
Expression frequency and rate of adverse events

Countries

Japan

Contacts

Public ContactMasae Kitagawa

Hiroshima University Hospital Center of Oral Clinical Examination

mhiraoka@hiroshima-u.ac.jp082-257-5727

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026