Diaper Rash
Conditions
Brief summary
This is a single-center, 1:1 randomized, double-blind, parallel-group, non-inferiority controlled trial to demonstrate non-inferiority of CeraVe Baby Diaper Rash Cream compared to Desitin Maximum Strength Original Paste when administered to children with diaper dermatitis who are between 3 months to 18 months of age. Parents/caregivers of subjects in both groups will administer the product with each diaper change throughout the course of the study period. Product can be applied liberally as needed. Diapers and skin cleansing interventions will stay constant throughout the treatment period. Subjects will be assessed by the study doctor, parent/caregiver will be asked about any adverse effects. Parent/caregivers will also 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. Parents/caregivers will also be given a questionnaire rating the use of the study products.
Detailed description
Visit 1 - Screening and Baseline Visit (Day 0) Subjects will be evaluated for study eligibility using inclusion and exclusion criteria. The study doctor will assess diaper dermatitis for inclusion and exclusion criteria and to verify mild to moderate severity. Once study eligibility has been confirmed, parental/guardian consent will be obtained. No washout period is necessary for this study. Location of clinically apparent involved area will be shaded by hand onto diagram by the research personnel. Study products will be dispensed to parent/caregiver, along with instructions for administration. Parent/caregivers will also 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. Parents/caregivers will be asked to complete the daily diary for each day of the study. Visit 2 (Day 7) Subjects will again be assessed by the study doctor. Parent/caregiver will be asked about any adverse effects in last 7 days. Visit 3 - End of study (Day 14) Subjects will again be assessed by the study doctor. Daily diaries and product will be collected at this time. Parent/caregiver will be asked about any adverse effects in last 7 days. Parents/caregivers will also be given a questionnaire rating the use of the study products.
Interventions
DRUGCeraVe 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) 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.
DRUGDesitin Maximum Strength Original Paste
Parents/caregivers of subjects will administer 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.
Sponsors
Bausch Health Americas, Inc.
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
3 Months to 18 Months
Healthy volunteers
No
Inclusion criteria
* Healthy children (except for diaper dermatitis) between 3 and 18 months of age * Wearing diapers 24 hours per day * Clinical irritant diaper dermatitis * Received a Diaper Dermatitis severity score of 1.0 to 2.0 by investigator at screening visit (mild-moderate severity) * Parent/caregiver will not change type or brand of diaper during the study, although the diaper type will be recorded * No alteration of current product usage for creams, lotions, ointments, powders, soap, laundry detergents, and fabric softeners * A parent or guardian of minors must sign the approved Institutional Review Board consent form prior to the conduct of any study-related procedures
Exclusion criteria
* Illness within past 4 days before study enrollment or any medical condition that may affect risk of study participation * Does not wear diapers 24 hours per day or currently being toilet trained * Active diagnosis or history of dermatological conditions other than diaper rash that may affect study * Concomitant use of medications that may affect study (e.g., antifungal, topical steroid, or topical calcineurin inhibitor) * Previous allergic reaction or known sensitivity to ingredients in study agents
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline for the Physician Assessment Diaper Dermatitis Scores to Day 14 for Each Treatment Group. | 14 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Physician Assessment Diaper Dermatitis Scores to Day 7 | 7 days | 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. |
| Parents/Caregivers Daily Scores Through Duration of the Study Period | 14 days | 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 |
| Assessment of Tolerability by the Infant | 14 days | 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 |
| Parent/Caregiver Rating of Satisfaction With Use of the Product | 14 days | Parents/caregivers will be given a questionnaire rating the use of the study products. |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 4 |
| Total | 4 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | CeraVe Baby Diaper Rash Cream/Desitin Maximum Strength Origina |
|---|---|
| Age, Continuous | 11.5 months STANDARD_DEVIATION 1.73 |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 4 |
| serious Total, serious adverse events | 0 / 4 |
Outcome results
Primary
Change From Baseline for the Physician Assessment Diaper Dermatitis Scores to Day 14 for Each Treatment Group.
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.
Time frame: 14 days
Population: Study was terminated prior to analysis due to low enrollment.
Secondary
Assessment of Tolerability by the Infant
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
Time frame: 14 days
Population: Study was terminated prior to analysis due to low enrollment.
Secondary
Change in Physician Assessment Diaper Dermatitis Scores to Day 7
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.
Time frame: 7 days
Population: Study was terminated prior to analysis due to low enrollment.
Secondary
Parent/Caregiver Rating of Satisfaction With Use of the Product
Parents/caregivers will be given a questionnaire rating the use of the study products.
Time frame: 14 days
Population: Study was terminated prior to analysis due to low enrollment.
Secondary
Parents/Caregivers Daily Scores Through Duration of the Study Period
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
Time frame: 14 days
Population: Study was terminated prior to analysis due to low enrollment.