Trial Outcomes & Findings for 14-Day Cumulative Irritation Patch Test in Subjects With Normal Skin - Chameleon (NCT NCT02737618)
NCT ID: NCT02737618
Last Updated: 2017-09-01
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
35 participants
Primary outcome timeframe
14 days
Results posted on
2017-09-01
Participant Flow
Participant milestones
| Measure |
Healthy Subject
Healthy subjects exposed to Trojan "Chameleon" Personal Lubricant applied by occlusive patch
Trojan "Chameleon" Personal Lubricant: silicone base with sensate
|
|---|---|
|
Overall Study
STARTED
|
43
|
|
Overall Study
COMPLETED
|
34
|
|
Overall Study
NOT COMPLETED
|
9
|
Reasons for withdrawal
| Measure |
Healthy Subject
Healthy subjects exposed to Trojan "Chameleon" Personal Lubricant applied by occlusive patch
Trojan "Chameleon" Personal Lubricant: silicone base with sensate
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
9
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Healthy Subject
n=34 Participants
Healthy subjects exposed to Trojan "Chameleon" Personal Lubricant applied by occlusive patch
Trojan "Chameleon" Personal Lubricant: silicone base with sensate
|
|---|---|
|
Age, Customized
18-69
|
34 Participants
n=34 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=34 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=34 Participants
|
PRIMARY outcome
Timeframe: 14 daysOutcome measures
| Measure |
Healthy Subject
n=34 Participants
Healthy subjects exposed to Trojan "Chameleon" Personal Lubricant applied by occlusive patch
Trojan "Chameleon" Personal Lubricant: silicone base with sensate
|
|---|---|
|
Number of Subjects That Showed Erythema Based on 5 Point Scoring Scale
|
0 Participants
|
PRIMARY outcome
Timeframe: 14 daysOutcome measures
| Measure |
Healthy Subject
n=34 Participants
Healthy subjects exposed to Trojan "Chameleon" Personal Lubricant applied by occlusive patch
Trojan "Chameleon" Personal Lubricant: silicone base with sensate
|
|---|---|
|
Number of Subjects That Showed Edema Based on the 5 Point Scoring Scale
|
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 PI
- Publication restrictions are in place
Restriction type: OTHER