Skin Irritation Clinical Trial
Determine the ability of the study material (personal lubricant) to cause sensitization by repeated topical application to the skin of humans under controlled patch test conditions.
Status | Completed |
Enrollment | 201 |
Est. completion date | December 2014 |
Est. primary completion date | December 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: - In general good health - Free of any systemic or dermatologic disorder which, in the opinion of the investigative personnel, will interfere with the study results or increase the risk of adverse events - Are of any skin type or race, providing the skin pigmentation will allow discernment of erythema - Complete a medical screening procedure - Read, understand, and sign an informed consent agreement Exclusion Criteria: - Have any visible skin disease at the study site which, in the opinion of the investigative personnel, will interfere with the evaluation - Are receiving systemic or topical drugs or medication which, in the opinion of the investigative personnel, will interfere with the study results - Have psoriasis and/or active atopic dermatitis/eczema. - Are females who are pregnant, planning on getting pregnant during the study, or breast-feeding - Have a known sensitivity for cosmetics, skin care products, topical drugs, or any other type of the products, as related to the material being evaluated |
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Screening
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Church & Dwight Company, Inc. |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants with Adverse Events as a Measure of Safety and Tolerability | Change from baseline to skin sensitization graded at 24, 48, and 72 hours after patch application | Yes |
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