CompletedInterventionalNot ApplicableUpdated Nov 10, 2015
Repeated Insult Patch Test of Personal Lubricants | NCT02297841 | Trialant
CompletedInterventionalNot ApplicableUpdated Oct 5, 2016
Repeated Insult Patch Test of Personal Lubricants
ClinicalTrials.gov ID
NCT02297841
Lead Sponsor
Church & Dwight Company, Inc.INDUSTRY
Overall Status
Completed
Study Type
Interventional
Phase
Not Applicable
Enrollment
209Actual
Last Update Posted
Oct 5, 2016Estimated
Start Date
Nov 2014
Primary Completion Date
Dec 2014Actual
Completion Date
Dec 2014Actual
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.
Erythema
Edema
Experimental: Novel lubricant Miami Fragrance
Experimental: Novel lubricant Miami no Fragrance
KY Liquid lubricant
Astroglide Gel lubricant
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
Yes
Eligibility Criteria
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