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

Primary Purpose

Diaper Rash

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Zinc Oxide Diaper Rash Ointment
Aloe Vera/Tocopherol/Zinc Oxide Cream
Sponsored by
Johnson & Johnson Consumer and Personal Products Worldwide
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diaper Rash

Eligibility Criteria

2 Months - 36 Months (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • JJCPPW Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

Trained evaluator's assessment of the severity of diaper rash and Parent/guardian's assessment of response to treatment

Secondary Outcome Measures

Adverse Events

Full Information

First Posted
September 13, 2005
Last Updated
August 19, 2011
Sponsor
Johnson & Johnson Consumer and Personal Products Worldwide
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1. Study Identification

Unique Protocol Identification Number
NCT00219466
Brief Title
Clinical Study to Evaluate the Efficacy and Safety of Two Marketed Investigational Products in Children With Diaper Rash
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2011
Overall Recruitment Status
Completed
Study Start Date
June 2005 (undefined)
Primary Completion Date
October 2005 (Actual)
Study Completion Date
October 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johnson & Johnson Consumer and Personal Products Worldwide

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diaper Rash

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigator
Allocation
Randomized
Enrollment
112 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Title
2
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Zinc Oxide Diaper Rash Ointment
Other Intervention Name(s)
Desitin Original, Formula 311-2
Intervention Description
Desitin Original at diaper change
Intervention Type
Other
Intervention Name(s)
Aloe Vera/Tocopherol/Zinc Oxide Cream
Other Intervention Name(s)
Desitin Creamy, Formula 316-1
Intervention Description
Desitin Creamy at diaper change
Primary Outcome Measure Information:
Title
Trained evaluator's assessment of the severity of diaper rash and Parent/guardian's assessment of response to treatment
Time Frame
At baseline and at 12 and 24 hours post-baseline
Secondary Outcome Measure Information:
Title
Adverse Events
Time Frame
during the course of the study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Months
Maximum Age & Unit of Time
36 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Qing Li, MD PhD
Organizational Affiliation
JJCPPW
Official's Role
Study Director
Facility Information:
Facility Name
JJCPPW Investigational Site
City
St. Petersburg
State/Province
Florida
ZIP/Postal Code
33710
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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