Status:
COMPLETED
Repeated Insult Patch Test of Personal Lubricants
Lead Sponsor:
Church & Dwight Company, Inc.
Conditions:
Erythema
Edema
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
209 Patients enrolled
Trial Details
Trial ID
NCT02297841
Start Date
November 1 2014
End Date
December 1 2014
Last Update
October 5 2016
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