Trial Outcomes & Findings for 14-Day Cumulative Irritation Patch Test in Subjects With Normal Skin (NCT NCT02309294)
NCT ID: NCT02309294
Last Updated: 2016-10-12
Results Overview
Score of less than or equal to 1.2 on the Cumulative Irritation Test scale (0-5).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
43 participants
Primary outcome timeframe
14 days
Results posted on
2016-10-12
Participant Flow
Participant milestones
| Measure |
Healthy Subject
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).
|
|---|---|
|
Overall Study
STARTED
|
43
|
|
Overall Study
COMPLETED
|
41
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Healthy Subject
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).
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
Baseline Characteristics
14-Day Cumulative Irritation Patch Test in Subjects With Normal Skin
Baseline characteristics by cohort
| Measure |
Healthy Subject
n=41 Participants
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).
|
|---|---|
|
Age, Customized
20-72
|
41 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 14 daysScore of less than or equal to 1.2 on the Cumulative Irritation Test scale (0-5).
Outcome measures
| Measure |
Healthy Subject
n=41 Participants
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).
|
|---|---|
|
Number of Subjects That Showed no Significant Irritation
|
0 participants
|
Adverse Events
Healthy Subject
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Master service agreement and confidentiality agreement in place
- Publication restrictions are in place
Restriction type: OTHER