Trial Outcomes & Findings for CeraVe Cream Compared to Desitin Paste for Treating Diaper Dermatitis in Infants (NCT NCT02299206)
NCT ID: NCT02299206
Last Updated: 2018-03-13
Results Overview
For each visit the study doctor will assess the diaper dermatitis severity with a Diaper Dermatitis Severity Score tool. In Addition, location of clinically apparent involved area will be shaded by hand onto diagram by the research personnel. Scores will be compared.
TERMINATED
NA
4 participants
14 days
2018-03-13
Participant Flow
Arms are combined for overall number of participants. Due to the low number of subjects, data will not be analyzed and the arm assignment for the subjects was not determined.
Participant milestones
| Measure |
CeraVe Baby Diaper Rash Cream/Desitin Maximum Strength Origina
Healthy 3-18 months old infants with mild to moderate diaper dermatitis.
CeraVe Baby Diaper Rash Cream: Parents/caregivers of subjects will administer CeraVe Baby Diaper Rash Cream (ingredients: Zinc oxide 10mg in 1g (1%) and dimethicone 10mg in 1g) or Desitin Maximum Strength Original Paste (ingredients: Zinc Oxide 40%) with each diaper change throughout the course of the study period. The product can be applied liberally as needed. Diapers and skin cleansing interventions will stay constant throughout the treatment period.
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|---|---|
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Overall Study
STARTED
|
4
|
|
Overall Study
COMPLETED
|
2
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
CeraVe Baby Diaper Rash Cream/Desitin Maximum Strength Origina
Healthy 3-18 months old infants with mild to moderate diaper dermatitis.
CeraVe Baby Diaper Rash Cream: Parents/caregivers of subjects will administer CeraVe Baby Diaper Rash Cream (ingredients: Zinc oxide 10mg in 1g (1%) and dimethicone 10mg in 1g) or Desitin Maximum Strength Original Paste (ingredients: Zinc Oxide 40%) with each diaper change throughout the course of the study period. The product can be applied liberally as needed. Diapers and skin cleansing interventions will stay constant throughout the treatment period.
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|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
CeraVe Cream Compared to Desitin Paste for Treating Diaper Dermatitis in Infants
Baseline characteristics by cohort
| Measure |
CeraVe Baby Diaper Rash Cream/Desitin Maximum Strength Origina
n=4 Participants
Healthy 3-18 months old infants with mild to moderate diaper dermatitis.
CeraVe Baby Diaper Rash Cream: Parents/caregivers of subjects will administer CeraVe Baby Diaper Rash Cream (ingredients: Zinc oxide 10mg in 1g (1%) and dimethicone 10mg in 1g) or Desitin Maximum Strength Original Paste (ingredients: Zinc Oxide 40%) with each diaper change throughout the course of the study period. The product can be applied liberally as needed. Diapers and skin cleansing interventions will stay constant throughout the treatment period.
|
|---|---|
|
Age, Continuous
|
11.5 months
STANDARD_DEVIATION 1.73 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
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Sex: Female, Male
Male
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1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 14 daysPopulation: Study was terminated prior to analysis due to low enrollment.
For each visit the study doctor will assess the diaper dermatitis severity with a Diaper Dermatitis Severity Score tool. In Addition, location of clinically apparent involved area will be shaded by hand onto diagram by the research personnel. Scores will be compared.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 7 daysPopulation: Study was terminated prior to analysis due to low enrollment.
For each visit the study doctor will assess the diaper dermatitis severity with a Diaper Dermatitis Severity Score tool. In Addition, location of clinically apparent involved area will be shaded by hand onto diagram by the research personnel. Scores will be compared.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 14 daysPopulation: Study was terminated prior to analysis due to low enrollment.
Parent/caregivers will be asked to complete a daily diary that asks about changes in their baby's diaper dermatitis, a Visual Analogue Scale severity assessment of their baby's diaper dermatitis, and observations related to product use and the baby's comfort level
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 14 daysPopulation: Study was terminated prior to analysis due to low enrollment.
Parent/caregivers will be asked to complete a daily diary that asks about changes in their baby's diaper dermatitis, a VAS severity assessment of their baby's diaper dermatitis, and observations related to product use and the baby's comfort level
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 14 daysPopulation: Study was terminated prior to analysis due to low enrollment.
Parents/caregivers will be given a questionnaire rating the use of the study products.
Outcome measures
Outcome data not reported
Adverse Events
CeraVe Baby Diaper Rash Cream/Desitin Maximum Strength Origina
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