A Parallel, Evaluator-Blind, Randomized Clinical Trial to Evaluate the Efficacy and Safety of Two Marketed Topical Skin Protectants Containing Zinc Oxide in Children With Diaper Rash
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 112
- 试验地点
- 2
- 主要终点
- Trained evaluator's assessment of the severity of diaper rash and Parent/guardian's assessment of response to treatment
研究概览
简要总结
To evaluate whether Desitin; Zinc Oxide Diaper Rash Ointment (Desitin Original) and Desitin Creamy; Zinc Oxide Diaper Rash Ointment (Desitin Creamy) provide relief of the signs and symptoms associated with diaper rash after 12 and 24 hours of product application.
详细描述
Subjects received applications of the investigational products following a gentle cleansing of the diaper zone at every diaper change and following bathing of the child during a 24 hour period.
Efficacy was assessed during this study through the documentation of the severity of diaper rash. Results of five anatomic areas and overall severity score by the evaluator's assessments, and parent/guardian's assessments all indicated that both products were significantly effective (P<0.05 in relieving diaper dermatitis (rash) after 12 and 24 hours of treatment.
Safety was assessed through the reporting of adverse events during the course of the study. Overall, the reporting of no adverse events under the conditions of the protocol indicate that the investigational products would appear to be safe for their intended use.
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
- 2 Months 至 36 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male and female children, 2-36 months of age
- •Wear diapers 24 hours per day
- •Present to the test facility for enrollment at baseline with diaper rash receiving an "Overall Severity Score" greater than or equal to 1.5 as determined by the trained evaluator
- •Parent/guardian signed informed consent
- •Parent/guardian willing to use only the test product in the diaper area during the trial
- •Parent/guardian willing to ensure that their child continues to wear their usual brand of diapers and will continue to clean their child during diaper changes using their usual products and method with the exception of ointments, lotions, creams or powders during the trial
- •Parent/guardian is willing to refrain from changing any other products whose use may have an effect on their child's skin condition during the trial, i.e., laundry detergents, fabric softeners, and products used to bathe the child
- •A Fitzpatrick Skin Type of I-IV
排除标准
- •Illness within 4 days preceding enrollment
- •Currently being toilet trained
- •Active dermatological conditions other than diaper rash that may affect trial results
- •History of recurrent dermatological conditions other than diaper rash that may affect trial results
- •Concomitant use of medications that may affect trial results
- •Known sensitivity to ingredients in trial medications
- •Known sensitivity, rash or other abnormal skin reaction to topical or systemic medications or cleansing products within one year of trial initiation
- •Other severe acute or chronic medical conditions that may increase the risk associated with trial participation or may interfere with the interpretation of results
结局指标
主要结局
Trained evaluator's assessment of the severity of diaper rash and Parent/guardian's assessment of response to treatment
时间窗: At baseline and at 12 and 24 hours post-baseline
次要结局
- Adverse Events(during the course of the study)