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

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

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.

Study Overview

• Status: Completed
• Conditions: Diaper Rash
• Intervention / Treatment: Other: Zinc Oxide Diaper Rash Ointment; Other: Aloe Vera/Tocopherol/Zinc Oxide Cream

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.

• Study Type: Interventional
• Enrollment (Actual): 112
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Florida
    • St. Petersburg, Florida, United States, 33710
      • JJCPPW Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 months to 3 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: 1	Other: Zinc Oxide Diaper Rash Ointment; Desitin Original at diaper change; Other Names: Desitin Original, Formula 311-2
ACTIVE_COMPARATOR: 2	Other: Aloe Vera/Tocopherol/Zinc Oxide Cream; Desitin Creamy at diaper change; Other Names: Desitin Creamy, Formula 316-1

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	Time Frame
Adverse Events	during the course of the study

Collaborators and Investigators

• Sponsor: Johnson & Johnson Consumer and Personal Products Worldwide
• Investigators: Study Director: Qing Li, MD PhD, JJCPPW

Study record dates

Study Major Dates

• Study Start: June 1, 2005
• Primary Completion (ACTUAL): October 1, 2005
• Study Completion (ACTUAL): October 1, 2005

Study Registration Dates

• First Submitted: September 13, 2005
• First Submitted That Met QC Criteria: September 13, 2005
• First Posted (ESTIMATE): September 22, 2005

Study Record Updates

• Last Update Posted (ESTIMATE): August 22, 2011
• Last Update Submitted That Met QC Criteria: August 19, 2011
• Last Verified: August 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Dermatitis; Skin Diseases, Eczematous; Dermatitis, Irritant; Dermatitis, Contact; Diaper Rash; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Dermatologic Agents; Trace Elements; Micronutrients; Vitamins; Antioxidants; Radiation-Protective Agents; Sunscreening Agents; Vitamin E; Tocopherols; alpha-Tocopherol; Tocotrienols; Zinc Oxide; Zinc
• Other Study ID Numbers: A2301007