NCT03886987

Skin Sensitization Test (Modified Draize-95 Test)

Skin Sensitization Test (Modified Draize-95 Test) to Support a Low Dermatitis Potential Claim

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 245 (actual)
• Sponsor: Central Medicare Sdn. Bhd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

Skin Sensitization Test (Modified Draize-95 Test) to Support a Low Dermatitis Potential Claim for a Blue Non Sterile Powder Free Nitrile Examination Gloves. This study is a RIPT (Repeat Insult Patch Test) to evaluate whether residual chemical additives at the level that may induce Type IV allergy in the nonsensitized general user population are present in a finished Blue Non Sterile Powder Free Nitrile Examination Glove.

Conditions

• Skin Sensitisation

Interventions

Type	Name	Description
DEVICE	Blue Non Sterile Powder Free Nitrile Examination Gloves	Approximately 2cm x 2cm square positioned to ensure that the inside portion of the test material maintained skin contact.

Timeline

• Start date: 2018-04-02
• Primary completion: 2018-06-08
• Completion: 2018-06-08
• First posted: 2019-03-22
• Last updated: 2019-03-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study