Status:
COMPLETED
Human Repeated Insult Patch Test
Lead Sponsor:
NeXtGen Biologics, Inc.
Conditions:
Dermatitis
Allergy
Eligibility:
All Genders
18-79 years
Phase:
NA
Brief Summary
Repeated insult patch test on healthy males and females to determine potential contact irritation or contact allergy in the skin
Eligibility Criteria
Inclusion
- Adults;
- Subjects must understand and execute an Informed Consent Form that includes a HIPAA statement;
- Subjects must be considered dependable and able to follow directions
Exclusion
- Subjects who are in ill health;
- Subjects who are taking medications other than birth control;
- Female subjects who are pregnant (return positive urine pregnancy test), planning to become pregnant or lactating during the course of the trial;
- Subjects who have a history of adverse reactions to personal care products, or known sensitivity to the test materials or their constituents including patch materials;
- Subjects with any active skin disease;
- Subjects who have heavy alcohol consumption;
- Subjects with current use or history of repeated use of street drugs;
- Subjects with a significant past medical history to potentially effect results of study;
- Subjects with immunization less than 10 days prior to the test patch application;
Key Trial Info
Start Date :
February 26 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 6 2018
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT03474874
Start Date
February 26 2018
End Date
April 6 2018
Last Update
July 16 2019
Active Locations (1)
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1
Consumer Product Testing Company, Inc.
Fairfield, New Jersey, United States, 07004