An interventional study of Novel lubricant Miami w/ fragrance and Novel lubricant Miami no fragrance in Cumulative Irritation, sponsored by Church & Dwight Company, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-10-12.
Sponsored by Church & Dwight Company, Inc. · Not applicable and Interventional
The objective of this study is to determine the ability of the study material to cause irritation to the skin of humans under controlled patch test conditions. Substances that come into contact with human skin need to be evaluated for their propensity to irritate and/or sensitize. This testing is a modified primary irritancy patch test that can detect weak irritants that require multiple applications to cause a skin reaction.
Church & Dwight Company, Inc. is the lead sponsor of 33 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Occlusive patches applied each day for 14 days for each intervention (Experimental: Novel lubricant Miami w/ fragrance, Experimental: Novel lubricant Miami no fragrance, KY Liquid lubricant, Astroglide Gel lubricant, Wet Platinum lubricant).
Device: Novel lubricant Miami w/ fragrance · Device: Novel lubricant Miami no fragrance · Device: KY Liquid lubricant · Device: Astroglide Gel lubricant · Device: Wet Platinum lubricant
0.2 ml aliquot on occlusive patch
0.2 ml aliquot on occlusive patch
0.2 ml aliquot on occlusive patch
0.2 ml aliquot on occlusive patch
0.2 ml aliquot on occlusive patch
Number of Subjects That Showed no Significant Irritation
Score of less than or equal to 1.2 on the Cumulative Irritation Test scale (0-5).
Time frame: 14 days
| Milestone | Healthy Subject |
|---|---|
| Started | 43 |
| Completed | 41 |
| Not completed | 2 |
| Withdrew: Withdrawal by subject | 2 |
Score of less than or equal to 1.2 on the Cumulative Irritation Test scale (0-5).
| participants | Healthy Subject |
|---|---|
| Number of Subjects That Showed no Significant Irritation | 0 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Healthy Subject | — | 0/41 (0%) | 0/41 (0%) |
| Age, Customized(participants) | Healthy Subject |
|---|---|
| 20-72 | 41 |
| Sex: Female, Male(Participants) | Healthy Subject |
|---|---|
| Female | 31 |
| Male | 10 |
This study is completed, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.
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Church & Dwight Company, Inc.