Trial Outcomes & Findings for Daily Use of Lipikar Balm AP From Birth in Infants at High Risk of Developing Atopic Dermatitis (NCT NCT01577628)
NCT ID: NCT01577628
Last Updated: 2016-04-21
Results Overview
Proportion of infants who develop atopic dermatitis at two years for infants randomized to Lipikar Balm AP as compared to infants randomized to the no intervention control group
TERMINATED
NA
2 participants
2 years
2016-04-21
Participant Flow
Participant milestones
| Measure |
Group 1: Lipikar Balm AP
Daily application of Lipikar Balm AP starting at birth
Lipikar Balm AP: Daily application of Lipikar Balm AP starting at birth
|
Group 2: No Intervention Control Group
Subjects may use a moisturizer if they wish to but no instruction or product is provided
|
Screen Only
Subject was not randomized to either treatment prior to study termination.
|
|---|---|---|---|
|
Overall Study
STARTED
|
0
|
0
|
2
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Daily Use of Lipikar Balm AP From Birth in Infants at High Risk of Developing Atopic Dermatitis
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: 2 yearsPopulation: Subjects were not randomized to either treatment prior to study termination and therefore no data was collected for this Outcome Measure
Proportion of infants who develop atopic dermatitis at two years for infants randomized to Lipikar Balm AP as compared to infants randomized to the no intervention control group
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 yearsPopulation: Subjects were not randomized to either treatment prior to study termination and therefore no data was collected for this Outcome Measure
Proportion of infants who develop asthma at two years for infants randomized to Lipikar Balm AP as compared to infants randomized to the no intervention control group
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 yearsPopulation: Subjects were not randomized to either treatment prior to study termination and therefore no data was collected for this Outcome Measure
Proportion of infants who develop a food allergy at two years for infants randomized to Lipikar Balm AP as compared to infants randomized to the no intervention control group
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 yearsPopulation: Subjects were not randomized to either treatment prior to study termination and therefore no data was collected for this Outcome Measure
Influence of the presence of mutation in the filaggrin gene on the proportion of infants who develop atopic dermatitis at two years for infants randomized to Lipikar Balm AP as compared to infants randomized to the no intervention control group
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 yearsPopulation: Subjects were not randomized to either treatment prior to study termination and therefore no data was collected for this Outcome Measure
Influence of the presence of mutation in the filaggrin gene on the proportion of infants who develop asthma at two years for infants randomized to Lipikar Balm AP as compared to infants randomized to the no intervention control group
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 yearsPopulation: Subjects were not randomized to either treatment prior to study termination and therefore no data was collected for this Outcome Measure
Influence of the presence of mutation in the filaggrin gene on the proportion of infants who develop a food allergy at two years for infants randomized to Lipikar Balm AP as compared to infants randomized to the no intervention control group
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 yearsPopulation: Subjects were not randomized to either treatment prior to study termination and therefore no data was collected for this Outcome Measure
Time of onset of asthma in infants randomized to Lipikar Balm AP as compared to infants randomized to the no intervention control group
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 yearsPopulation: Subjects were not randomized to either treatment prior to study termination and therefore no data was collected for this Outcome Measure
Time of onset of food allergy in infants randomized to Lipikar Balm AP as compared to infants randomized to the no intervention control group
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 yearsPopulation: Subjects were not randomized to either treatment prior to study termination and therefore no data was collected for this Outcome Measure
Adverse events (Skin AEs, asthma, food allergies, allergic rhinitis and any AE related to Lipikar Syndet, Lipikar Balm AP (group 1) or any other moisturizer application (group 2) will be collected.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 yearsPopulation: Subjects were not randomized to either treatment prior to study termination and therefore no data was collected for this Outcome Measure
Time of onset of atopic dermatitis in infants randomized to Lipikar Balm AP as compared to infants randomized to the no intervention control group
Outcome measures
Outcome data not reported
Adverse Events
Group 1: Lipikar Balm AP
Group 2: No Intervention Control Group
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