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

NCT00219466 | Completed Phase 4

• 1 other identifier: A2301007
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

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.

Conditions

Diaper Rash

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Adverse Events

  during the course of the study

Study Arms (2)

1

ACTIVE COMPARATOR

Other: Zinc Oxide Diaper Rash Ointment

2

ACTIVE COMPARATOR

Other: Aloe Vera/Tocopherol/Zinc Oxide Cream

Interventions

Zinc Oxide Diaper Rash Ointment OTHER

Desitin Original at diaper change

Also known as: Desitin Original, Formula 311-2

1

Aloe Vera/Tocopherol/Zinc Oxide Cream OTHER

Desitin Creamy at diaper change

Also known as: Desitin Creamy, Formula 316-1

2

Eligibility Criteria

• Age: 2 Months - 36 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johnson & Johnson Consumer and Personal Products Worldwide: lead

Study Sites (1)

JJCPPW Investigational Site

St. Petersburg, Florida, 33710, United States

Location

MeSH Terms

Conditions

Diaper Rash

Condition Hierarchy (Ancestors)

Dermatitis, Irritant; Dermatitis, Contact; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous

Study Officials

• Qing Li, MD PhD

  JJCPPW

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 22, 2005
• Study Start: June 1, 2005
• Primary Completion: October 1, 2005
• Study Completion: October 1, 2005
• Last Updated: August 22, 2011

Record last verified: 2011-08

Locations

US (1)