Trial Outcomes & Findings for An Open-Label Study Investigating the Effects of Early Skin Barrier Protection on the Development of Atopic Dermatitis (NCT NCT00806221)
NCT ID: NCT00806221
Last Updated: 2017-07-11
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
22 participants
Primary outcome timeframe
1 and 2 year time points
Results posted on
2017-07-11
Participant Flow
Participant milestones
| Measure |
Emollient
Emollient (Cetaphil cream): Cetaphil cream applied daily from birth
|
|---|---|
|
Overall Study
STARTED
|
22
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
An Open-Label Study Investigating the Effects of Early Skin Barrier Protection on the Development of Atopic Dermatitis
Baseline characteristics by cohort
| Measure |
Emollient
n=22 Participants
Skin barrier protection from birth
emollient (Cetaphil cream): Cetaphil cream applied daily from birth
|
|---|---|
|
Age, Categorical
<=18 years
|
22 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
|
Sex/Gender, Customized
gender/sex was not recorded
|
22 participants
n=99 Participants
|
|
Race/Ethnicity, Customized
non-Hispanic Caucasian
|
16 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Hispanic Caucasian
|
2 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
African American
|
2 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
22 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 1 and 2 year time pointsOutcome measures
| Measure |
Emollient
n=22 Participants
Emollient (Cetaphil cream): Cetaphil cream applied daily from birth
|
|---|---|
|
Incidence of Skin Irritation
|
0 Participants
|
PRIMARY outcome
Timeframe: 1 and 2 year timepointsOutcome measures
| Measure |
Emollient
n=22 Participants
Emollient (Cetaphil cream): Cetaphil cream applied daily from birth
|
|---|---|
|
Incidence of Skin Infection
|
0 Participants
|
PRIMARY outcome
Timeframe: over two yearsOutcome measures
| Measure |
Emollient
n=22 Participants
Emollient (Cetaphil cream): Cetaphil cream applied daily from birth
|
|---|---|
|
Compliance With Protocol
|
20 participants
|
SECONDARY outcome
Timeframe: 1 and 2 year time pointsOutcome measures
| Measure |
Emollient
n=22 Participants
Emollient (Cetaphil cream): Cetaphil cream applied daily from birth
|
|---|---|
|
Development of Eczema
|
5 Participants
|
Adverse Events
Emollient
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
Eric Simpson, MD, MCR
Oregon Health & Science University
Phone: 503-494-2121
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place