Study on Establishment of Allergy Confirmation Method for Cosmetics and Others

JRCT ID: jRCTs041180105

Registered date:18/03/2019

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Allergic contact dermatitis
• Date of first enrollment: 25/01/2019
• Target sample size: 1000
• Study type: Interventional
• Intervention(s): Apply allergen (unapproved drug) to the patient and confirm allergy.

Outcome(s)

• Primary Outcome: Survey analysis of cases of problems in the skin and the body such as contact dermatitis in Japan

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Both

Include criteria

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.

• Exclude criteria: A patient whose research doctor judges that participation in research is inappropriate

Related Information

• Primary Sponsor: Yagami Akiko