Trial Outcomes & Findings for Human Repeat Insult Patch Test to Evaluate Personal Lubricants (NCT NCT02737631)
NCT ID: NCT02737631
Last Updated: 2021-04-15
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
222 participants
Primary outcome timeframe
24, 48 and 72 hours after patch application
Results posted on
2021-04-15
Participant Flow
Participant milestones
| Measure |
Healthy Subject
Healthy subjects exposed to Trojan "Chameleon" personal lubricant via occlusive patch
Trojan "Chameleon" Personal Lubricant
|
|---|---|
|
Overall Study
STARTED
|
222
|
|
Overall Study
COMPLETED
|
222
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Healthy Subject
n=222 Participants
Healthy subjects exposed to Trojan "Chameleon" personal lubricant via occlusive patch
Trojan "Chameleon" Personal Lubricant
|
|---|---|
|
Age, Customized
18-69 years
|
222 Participants
n=222 Participants
|
|
Sex: Female, Male
Female
|
150 Participants
n=222 Participants
|
|
Sex: Female, Male
Male
|
72 Participants
n=222 Participants
|
PRIMARY outcome
Timeframe: 24, 48 and 72 hours after patch applicationOutcome measures
| Measure |
Healthy Subject
n=222 Participants
Healthy subjects exposed to "Chameleon" personal lubricant via occlusive patch
"Chameleon" Personal Lubricant
|
|---|---|
|
Number of Patients That Showed Sensitization Reaction to the Test Material at Challenge
|
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 Confidentiality agreement in place with PIs.
- Publication restrictions are in place
Restriction type: OTHER