14-Day Cumulative Irritation Patch Test in Subjects With Normal Skin - Chameleon
ClinicalTrials.gov ID
NCT02737618
Lead Sponsor
Church & Dwight Company, Inc.INDUSTRY
Overall Status
Completed
Study Type
Interventional
Phase
Not Applicable
Enrollment
35Actual
Last Update Posted
Sep 1, 2017Actual
Start Date
Feb 2016
Primary Completion Date
Mar 2016Actual
Completion Date
Mar 2016Actual
Brief Summary
to determine the ability of the test article to cause irritation to the skin of humans under controlled patch test conditions
Dermal Irritation
Trojan "Chameleon" Personal Lubricant
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
Yes
Eligibility Criteria
Inclusion Criteria:
male or female, 18-70 years of age, in general good health
normal skin
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
of any skin type or race providing the skin pigmentation will allow discernment of erythema
agree to complete a medical history and concomitant medication form
read, understand and sign informed consent
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
have a known sensitivity to cosmetics, skin care test articles, or topical drugs as related to the test article being evaluated
are females who are pregnant or breastfeeding or become pregnant