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

Completed · Phase 4

Conditions studied: Diaper Rash

In brief

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.

Key facts

Study ID

NCT00219466

Run by

Johnson & Johnson Consumer and Personal Products Worldwide

People needed

112

Starts

2005-06-01

Expected to finish

2005-10-01

Last updated by the study team

2011-08-22

Who can join

Age: 0 and older, up to 3. Sex: any. Healthy volunteers: accepted.

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

Where it is running

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

Full record on ClinicalTrials.gov

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