A Clinical Study to Evaluate The Efficacy of Two Marketed Zinc Oxide-Based Diaper Rash Ointments in Children with Diaper Dermatitis
W. Michael Brown, MD, FAAP1, Jeffrey E. Berg, BS1, Qing Li, MD, PhD2, Bruce E. Kohut, DMD2, 1 - Health & Personal Care, Hill Top Research, St. Petersburg, FL, USA, 2 - Global Medical Affairs & Clinical Research, Pfizer Consumer Healthcare, Morris Plains, NJ, USA. Presented at The Fall Clinical Dermatology Conference, October 6-9, 2006. Las Vegas, NV.
ABSTRACT
The objective of this study was to evaluate whether two marketed topical zinc oxide-based diaper rash products provided relief of diaper dermatitis after 12 and 24 hours of treatment.
This was an evaluator-blinded, two-arm, randomized, parallel trial conducted on children 2-36 months old and wearing diapers 24 hours a day. Severity of diaper dermatitis was assessed by a trained skin evaluator and parents/guardians after 12 and 24 hours of treatment. Subjects were enrolled and randomized if they received an overall severity score of mild/moderate or higher at baseline by the trained evaluator. Investigational products (IPs) were applied following a gentle cleansing of the diaper zone at every diaper change and following bathing of the subject.
Results of the analyses of the 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 after 12 and 24 hours of treatment.
