Sponsor study identifier
interventional
245
1 country
1
Study Start
April 2, 2018
Actual (reported)Primary Completion
June 8, 2018
Actual (reported)Study Completion
June 8, 2018
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 8, 2018
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 2, 2018
Actual (reported)June 8, 2018
Actual (reported)June 8, 2018
Actual (reported)March 18, 2019
Actual (reported)March 22, 2019
Actual (reported)Irritation scored by Erythemal Scoring Scale
Basic Score and Description: 0 - No visible reaction. 0.5 - Doubtful or negligible erythema reaction. 1.0 - Mild or just perceptible macular erythema reaction in a speckled/follicular, patchy or confluent pattern (slight pinking). 2.0 - Moderate erythema reaction in a confluent pattern (definite redness). 3.0 - Strong or brisk erythema reaction that may spread beyond the test site. If a subject develops a positive reaction (a score value of 1.5) to the test material or shows signs of irritation after patch applications, further patching on those individuals are stopped. In order to qualify for the claim of a reduced sensitization potential, all 200 individuals completing the study should exhibit a score value of no more than 1.5 based on the scoring criteria.
8 weeks
Blue Non Sterile Powder Free Nitrile Examination Gloves Dose: Approximately 2cm x 2cm square positioned to ensure that the inside portion of the test material maintained skin contact. Positive control: 0.4% sodium lauryl sulfate (SLS) Dose: 0.2 ml Negative control: Blank patch Dose: Not applicable
Approximately 2cm x 2cm square positioned to ensure that the inside portion of the test material maintained skin contact.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Consumer Product Testing Company, Inc.
Fairfield, New Jersey, 07004, United States
Michael Caswell, Ph.D., CCRA, CCRC
Consumer Product Testing Company, Inc.
245 participants (actual enrollment reported by the registry).
First Submitted
March 18, 2019
First Posted
March 22, 2019
Study Start
Safety Dermatological Assessment of Topical Use Product Through Dressings Predictive Studies for Evaluation of Photoirritation and Dermal Photosensitivity
Contact the study team to confirm eligibility.
April 2, 2018
Actual (reported)Primary Completion
June 8, 2018
Actual (reported)Study Completion
June 8, 2018
Actual (reported)Last Updated
March 22, 2019
Record last verified: 2019-03
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Source: ClinicalTrials.gov.
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