Randomized, Double-Blind, Parallel Group, Non-Inferiority Clinical Trial of CeraVe Baby Diaper Rash Cream Compared to Desitin Maximum Strength Original Paste for Management of Diaper Dermatitis in Infants
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 3
- 主要终点
- Change From Baseline for the Physician Assessment Diaper Dermatitis Scores to Day 14 for Each Treatment Group.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Care Provider, Investigator)
入排标准
- 年龄范围
- 3 Months 至 18 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
CeraVe Baby Diaper Rash Cream
Healthy 3-18 months old infants with mild to moderate diaper dermatitis.
干预措施: CeraVe Baby Diaper Rash Cream (Drug)
Desitin Maximum Strength Original Paste
Healthy 3-18 months old infants with mild to moderate diaper dermatitis.
干预措施: Desitin Maximum Strength Original Paste (Drug)
结局指标
主要结局
Change From Baseline for the Physician Assessment Diaper Dermatitis Scores to Day 14 for Each Treatment Group.
时间窗: 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.
次要结局
- Change in Physician Assessment Diaper Dermatitis Scores to Day 7(7 days)
- Parents/Caregivers Daily Scores Through Duration of the Study Period(14 days)
- Assessment of Tolerability by the Infant(14 days)
- Parent/Caregiver Rating of Satisfaction With Use of the Product(14 days)
研究者
Amy Paller
Professor and Chair of Department of Dermatology, Professor of Pediatrics
Northwestern University