Trial Outcomes & Findings for Controlled Study of the Effect of Xenaderm® Ointment Vehicle Versus White Petrolatum on Healing (NCT NCT00713349)
NCT ID: NCT00713349
Last Updated: 2013-12-06
Results Overview
Each subject acting as their own control
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
25 participants
Primary outcome timeframe
21 Days
Results posted on
2013-12-06
Participant Flow
Healthy adult volunteers, 18 years of age and older
Each subject acting as their own control
Participant milestones
| Measure |
Vehicle vs. Placebo
Xenaderm Vehicle and White Petrolatum as Placebo Comparator
Xenaderm Vehicle : Ointment to be applied three times a day on cryo-surgery wound for 21 days.
White Petrolatum : Ointment to be applied three times a day on cryo-surgery wound for 21 days
Each subject acting as their own control
|
|---|---|
|
Overall Study
STARTED
|
25
|
|
Overall Study
COMPLETED
|
24
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Vehicle vs. Placebo
Xenaderm Vehicle and White Petrolatum as Placebo Comparator
Xenaderm Vehicle : Ointment to be applied three times a day on cryo-surgery wound for 21 days.
White Petrolatum : Ointment to be applied three times a day on cryo-surgery wound for 21 days
Each subject acting as their own control
|
|---|---|
|
Overall Study
Protocol Violation
|
1
|
Baseline Characteristics
Controlled Study of the Effect of Xenaderm® Ointment Vehicle Versus White Petrolatum on Healing
Baseline characteristics by cohort
| Measure |
Vehicle vs. Placebo
n=25 Participants
Xenaderm Vehicle and White Petrolatum as Placebo Comparator
Xenaderm Vehicle : Ointment to be applied three times a day on cryo-surgery wound for 21 days.
White Petrolatum : Ointment to be applied three times a day on cryo-surgery wound for 21 days
Each subject acting as their own control
|
|---|---|
|
Age, Categorical
<=18 years
|
1 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
24 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age Continuous
|
43 years
STANDARD_DEVIATION 12.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 21 DaysEach subject acting as their own control
Outcome measures
| Measure |
Vehicle
n=24 Participants
Xenaderm Ointment Vehicle : each subject acting as their own control
|
Placebo Control
n=24 Participants
White Petrolatum : each subject acting as their own control
|
|---|---|---|
|
Complete Wound Closure
|
14.8 days
Standard Deviation 1.1
|
14.9 days
Standard Deviation 1.3
|
Adverse Events
Vehicle
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Placebo Control
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Vehicle
n=25 participants at risk
Xenaderm Ointment Vehicle : each subject acting as their own control
|
Placebo Control
n=25 participants at risk
White Petrolatum : each subject acting as their own control
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders
|
24.0%
6/25 • Number of events 6 • 21 days
|
24.0%
6/25 • Number of events 6 • 21 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60