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Mar. 18, 2019

Oct. 15, 2026

jRCTs041180105

Study on Establishment of Allergy Confirmation Method for Cosmetics and Others (Study on Establishment of Allergy Confirmation Method for Cosmetics and Others)

Study on Establishment of Allergy Confirmation Method for Cosmetics and Others (Study on Establishment of Allergy Confirmation Method for Cosmetics and Others)

Yagami Akiko

Fujita Health University Bantane Hospital

3-6-10,Otobashi, Nakagawa-ku, Nagoya, Aichi 454-8509, Japan

+81-52-323-5714

ayagami@fujita-hu.ac.jp

shibata mina

Fujita Health University

3-6-10,Otobashi, Nakagawa-ku, Nagoya, Aichi 454-8509, Japan

+81-52-323-5714

mina.shibata@fujita-hu.ac.jp

Recruiting

Jan. 25, 2019

Jan. 25, 2019
30000

Interventional

single arm study

open(masking not used)

no treatment control/standard of care control

single assignment

diagnostic purpose

Allergy / photoallergic contact dermatitis, allergic contact urticaria (syndrome), protein contact dermatitis, immediate allergy by ingestion, irritant / irritant / allergic contact erythema (syndrome) due to products and chemical substances used routinely such as cosmetics, Understanding the purpose of this research and notifying the applicant in written form, in patients who are suffering skin and body disorders such as phototoxic contact dermatitis, vitiligo / depigmenting plaques, chemical burns, etc., satisfying certain qualification criteria and not meeting exclusion criteria Children aged (under 20 years old) and adults (over 20 years old)
Selection criteria
1) Patients should have skin disorder induced by any substance / product applied / contacted to the skin.
2) Be patient who is willing to comply with the research implementation plan.
3) Sign the consent form approved by the Ethics Review Committee of the medical institution conducting the trial
about.

A patient whose research doctor judges that participation in research is inappropriate

No limit
No limit

Both

Allergic contact dermatitis

Apply allergen (unapproved drug) to the patient and confirm allergy.

Survey analysis of cases of problems in the skin and the body such as contact dermatitis in Japan

Search for harmful cases
Sensitization rate of contact dermatitis allergens
Number of cases by region
Number of occupational skin disorder cases
Comparison with historical data

Japanese Cosmetic Science Society
Fujita Health University Certified Clinical Research Review Board
1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Japan, Aichi

+81-562-93-2865

crb-f@fujita-hu.ac.jp
Approval

Feb. 14, 2019

none

History of Changes

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