Clinical Study to Evaluate the Efficacy and Safety of Two Marketed Investigational Products in Children With Diaper Rash

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Diaper Rash

Intervention / Treatment
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* Other: Zinc Oxide Diaper Rash Ointment
* Other: Aloe Vera/Tocopherol/Zinc Oxide Cream


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 2 Months
Maximum Age: 36 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br> | Other: Zinc Oxide Diaper Rash Ointment<br>* Desitin Original at diaper change<br>* Other names: Desitin Original, Formula 311-2;|
| Active Comparator: 2<br> | Other: Aloe Vera/Tocopherol/Zinc Oxide Cream<br>* Desitin Creamy at diaper change<br>* Other names: Desitin Creamy, Formula 316-1;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Trained evaluator's assessment of the severity of diaper rash and Parent/guardian's assessment of response to treatment |  | At baseline and at 12 and 24 hours post-baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events |  | during the course of the study |