Trial Outcomes & Findings for A Study to Investigate the Use of Hydrogel Vehicle in Maintaining the Skin Barrier in Persons With Atopic Dermatitis (NCT NCT01065714)
NCT ID: NCT01065714
Last Updated: 2013-04-25
Results Overview
The average of three sequential Tewameter 300 meter readings taken at a minimum of one minute intervals on targeted area of body half treated with Eucerin lotion
COMPLETED
PHASE4
20 participants
Day 1 to Day 14
2013-04-25
Participant Flow
Recruitment from March 2010 through September 2010. Subjects enrolled from physician data base.
Participant milestones
| Measure |
Hydrogel Vehicle/Eucerin Lotion
Parallel designed study. Split body treatment. Eucerin Lotion applied to one side of body, Hydrogel applied to the opposite side of body.
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Investigate the Use of Hydrogel Vehicle in Maintaining the Skin Barrier in Persons With Atopic Dermatitis
Baseline characteristics by cohort
| Measure |
Hydrogel Vehicle/Eucerin Lotion
n=20 Participants
Parallel designed study. Split body treatment
|
|---|---|
|
Age, Categorical
<=18 years
|
4 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=99 Participants
|
|
Age Continuous
|
35 years
STANDARD_DEVIATION 16.0 • n=99 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Day 14Population: per protocol
The average of three sequential Tewameter 300 meter readings taken at a minimum of one minute intervals on targeted area of body half treated with Eucerin lotion
Outcome measures
| Measure |
Skin Barrier Function With Eucerin Lotion
n=20 Participants
Measurement of TEWL on targeted area on one side of body treated with Eucerin Lotion
|
|---|---|
|
Percent Change of Trans Epidermal Water Loss (TEWL) With Use of Eucerin Lotion
|
21.4 percent change
Full Range 54.8 • Interval -66.8 to 214.8
|
PRIMARY outcome
Timeframe: Day 1 to Day 14Population: Per protocol
The average of three sequential Tewameter 300 meter readings taken at a minimum of one minute intervals on target areas of body half treated with Hydrogel vehicle
Outcome measures
| Measure |
Skin Barrier Function With Eucerin Lotion
n=20 Participants
Measurement of TEWL on targeted area on one side of body treated with Eucerin Lotion
|
|---|---|
|
Percent Change of Trans Epidural Water Loss (TEWL) With the Use of Hydrogel Vehicle
|
4.2 percent change
Full Range 31.2 • Interval -76.9 to 57.9
|
SECONDARY outcome
Timeframe: Baseline to 14 daysPopulation: per protocol
Five timed readings ( 0, 15, 30, 45 and 60 minutes) were taken using the Corneometer 825 meter on subjects using Eucerin lotion on targeted area on one half of body
Outcome measures
| Measure |
Skin Barrier Function With Eucerin Lotion
n=20 Participants
Measurement of TEWL on targeted area on one side of body treated with Eucerin Lotion
|
|---|---|
|
Percentage of Participants With an Increase in Skin Hydration Using Eucerin Lotion on Targeted Area on One Half of Body
|
33.5 Percentage of participants
Standard Deviation 72.2
|
SECONDARY outcome
Timeframe: Baseline to 14 daysPopulation: per protocol
Five timed readings at (0, 15, 30, 45 and 60 minutes) were taken, using the Corneometer 825 meter, on participants using Hydrogel vehicle
Outcome measures
| Measure |
Skin Barrier Function With Eucerin Lotion
n=20 Participants
Measurement of TEWL on targeted area on one side of body treated with Eucerin Lotion
|
|---|---|
|
Percentage of Participants With an Increase in Skin Hydration Using Hydrogel Vehicle on Targeted Area of One Half of Body.
|
32.3 percentage of participants
Standard Deviation 51.5
|
Adverse Events
Hydrogel Vehicle/Eucerin Lotion
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
- Publication restrictions are in place