Trial Outcomes & Findings for Repeated Insult Patch Test of Personal Lubricants (NCT NCT02297841)
NCT ID: NCT02297841
Last Updated: 2016-10-05
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
209 participants
Primary outcome timeframe
24, 48, and 72 hours after patch application
Results posted on
2016-10-05
Participant Flow
Participant milestones
| Measure |
Human Repeat Insult Patch Test
Experimental: Human Repeat Insult Patch Test
Approximately 0.2ml of each intervention (Experimental: Novel lubricant Miami Fragrance, Experimental: Novel lubricant Miami no Fragrance, KY Liquid lubricant, Astroglide Gel lubricant) was applied to an occlusive patch and applied to participant's back.
|
|---|---|
|
Overall Study
STARTED
|
209
|
|
Overall Study
Induction Phase
|
209
|
|
Overall Study
Challenge Phase
|
201
|
|
Overall Study
COMPLETED
|
201
|
|
Overall Study
NOT COMPLETED
|
8
|
Reasons for withdrawal
| Measure |
Human Repeat Insult Patch Test
Experimental: Human Repeat Insult Patch Test
Approximately 0.2ml of each intervention (Experimental: Novel lubricant Miami Fragrance, Experimental: Novel lubricant Miami no Fragrance, KY Liquid lubricant, Astroglide Gel lubricant) was applied to an occlusive patch and applied to participant's back.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Protocol Violation
|
7
|
Baseline Characteristics
Repeated Insult Patch Test of Personal Lubricants
Baseline characteristics by cohort
| Measure |
HRIPT
n=201 Participants
Novel lubricant Miami w/ fragrance Novel lubricant Miami w/o fragrance 510(k) cleared and currently marketed personal lubricant 510(k) cleared and currently marketed personal lubricant
|
|---|---|
|
Age, Customized
18-70
|
201 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
161 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
40 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24, 48, and 72 hours after patch applicationOutcome measures
| Measure |
Human Repeat Insult Patch Test
n=201 Participants
Experimental: Human Repeat Insult Patch Test
Approximately 0.2ml of each intervention (Experimental: Novel lubricant Miami Fragrance, Experimental: Novel lubricant Miami no Fragrance, KY Liquid lubricant, Astroglide Gel lubricant) was applied to an occlusive patch and applied to participant's back.
|
|---|---|
|
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
|
0 participants
|
Adverse Events
HRIPT
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