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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary:

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.

Sponsor: Johnson & Johnson Consumer and Personal Products Worldwide

Current Primary Outcome: 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 ]

Original Primary Outcome: Trained evaluator's assessment of the severity of diaper rash Parent/guardian's assessment of response to treatment

Current Secondary Outcome: Adverse Events [ Time Frame: during the course of the study ]

Original Secondary Outcome:

Information By: Johnson & Johnson Consumer and Personal Products Worldwide

Dates:
Date Received: September 13, 2005
Date Started: June 2005
Date Completion:
Last Updated: August 19, 2011
Last Verified: August 2011