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

NCT ID: NCT00219466

Last Updated: 2011-08-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 112 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-06-30
• Study Completion Date: 2005-10-31

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.

Conditions

Diaper Rash

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1

Group Type: ACTIVE_COMPARATOR

Zinc Oxide Diaper Rash Ointment

Intervention Type: OTHER

Desitin Original at diaper change

2

Group Type: ACTIVE_COMPARATOR

Aloe Vera/Tocopherol/Zinc Oxide Cream

Intervention Type: OTHER

Desitin Creamy at diaper change

Interventions

Zinc Oxide Diaper Rash Ointment

Desitin Original at diaper change

Intervention Type: OTHER

Aloe Vera/Tocopherol/Zinc Oxide Cream

Desitin Creamy at diaper change

Intervention Type: OTHER

Other Intervention Names

Desitin Original, Formula 311-2; Desitin Creamy, Formula 316-1

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

• Minimum Eligible Age: 2 Months
• Maximum Eligible Age: 36 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Johnson & Johnson Consumer and Personal Products Worldwide

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Qing Li, MD PhD

Role: STUDY_DIRECTOR

JJCPPW

Locations

JJCPPW Investigational Site

St. Petersburg, Florida, United States

Countries

United States

Other Identifiers

A2301007

Identifier Type: -

Identifier Source: org_study_id